Resources

There is an increasing number of digital tools available to us as clinical researchers, as our industry continues to work to streamline the complex process of running clinical trials. These technologies can help us improve efficiency, accuracy, and the participant experience, but our strategies for implementing these resources do matter. As a site operations lead for an IRO, or Integrated Research Organization (Javara), I am embedded within a health care facility in Savannah, Georgia. Working as an extension of the care teams at this practice, our approach to new technological resources has illuminated a lot of inefficiencies and areas for growth. For example, we have found that just the initial shift from paper to an eSource system leads to significant improvements, such as more rapid identification or anomalous data, and ensuring audit readiness. There are a multitude of additional systems that can be used in tandem with the eSource system, and many are worth incorporating, but it is important to note that just the first step of eSource implementation is impactful to evolve the way in which trials are run. A multitude of systems The current trend for technologies in clinical research is integration and interoperability. When systems communicate with each other, it increases data accuracy and improves trial efficiency by streamlining workflows. At our sites, we are also experienced interacting with the electronic data capture (EDC) systems that are provided by sponsors to all trial locations. The benefit of leveraging these platforms is they aggregate data from various sites, with clear visibility for the sponsor at all times. The system validates data, manages queries, and hosts audit trails allowing sponsors to manage data efficiently and comply with regulatory standards. The eSource system is the heart of the digital system at the site level. These systems are electronic platforms used to capture data right at the source. Instead of recording data on paper, it can now be entered digitally during participant visits. We use this system both during the trial and also to retain participant information after the study has concluded and the sponsor has removed site access to their systems. Our eSource system does not currently communicate directly with EDC systems, as it is vital that strong measures be in place for data integrity and security. However, entering data into EDC systems from our eSource system instead of via paper charts alone improves efficiencies greatly. A variety of other systems do connect with eSource systems, EDC systems or both, some of which we do leverage as well. Examples of other systems integrating with eSource include: Recruitment platforms, which use data from electronic health records (EHRs) as well as demographic analysis to identify potential participants. These platforms generally integrate with eSource systems to automatically update participant status and share eligibility data. Scheduling tools, which also integrate with eSource systems and send automated reminders to site staff and participants. eConsent systems, which provide digital, interactive documents, send signed consent forms to the participants directly. This is also stored for quick accessibility to sites. Randomization and trial supply management (RTSM) systems, which also can integrate with both eSource and EDC systems, automating participant randomization, drug inventory management, and the allocation and tracking of study treatments across trial sites. Choosing the right system As helpful and time effective as these new systems can be, it is important to be diligent in researching each system’s capabilities and limitations to find the tools or technologies that best meet your needs. For example, are you looking for a tool to improve patient recruitment? Or something to speed up data collection and reporting? These questions can be challenging to answer in an environment of rapid advancement, where both current features and future capabilities are important aspects of a comparison and require mindful evaluation. Additionally, it is crucial to choose a vendor who is willing to listen to your site or company’s needs and real-time feedback from staff. The best vendor partners should take into consideration what research sites say is working, not working, or slowing down processes and adapt. Another important consideration when evaluating and choosing the right system is sponsor support. It is critical that both that sponsors listen to what sites need from their EDC systems and that sites communicate those needs directly. I have been on many calls with sponsors who were genuine when inquiring what they could do to save time and maximize resources for us at the site level. Sites expressed a desire to have the data they enter into randomization and screening systems automatically transfer into the sponsor’s EDC system, and together, we were able to make that happen. In the past year or two, this has become much more common, and I foresee these collaborative conversations between sites and sponsors on how to improve our technologies and efficiencies will only continue to increase. Facilitating support for investigators and trial sites An important part of our job as an integrated research organization is supporting our physician investigators through the process of integrating research into their clinical practice. New technologies have been helpful as part of this process. For example, electronic signatures have made study start-up faster. Another valuable aspect of these newer systems is automation of notifications and reminders to investigators. Physicians are very busy, and it is important that the process be as simple and clear for them as possible, and task reminders are very beneficial. Additionally, the more user-friendly the new systems are, the easier the implementation will be. Training is important, of course, and it is wise to conduct a pilot test before a new rollout. Informing staff about the process and the benefits of implementation will increase enthusiasm and commitment. Communication is key when rolling out new technologies or other resources, and helping teams and investigators understand how this new system or platform will improve efficiency, save time and simplify their daily responsibilities also drives buy-in. I have found that staff generally appreciate the efficiencies of new systems and are eager to see them successfully implemented. We have heard frustration from some physician investigators about the high number of passwords that they must currently juggle when systems are consolidated, concerns of this nature can also be addressed. Technologies ultimately provide critical elements of simplification which empowers all involved. Technology empowers decentralized studies The opportunity for decentralized clinical trials has become increasingly common in recent years, and remote monitoring technologies have played a significant role in making this possible. Some of these technologies send real-time data. Others do not transmit in real-time but rather store information that is then downloaded during a patient visit. Both are valuable to site operations. We recently did our first decentralized study, made possible by telehealth visits, which provided a sizable boost in patient access. Though I believe some face-to-face contact will always be important to build relationships, cultivate trust, and maintain compliance, decentralized studies have large potential to improve the patient experience. There are many technological advancements that enable decentralized trials, but the adoption of remote devices that communicate smoothly with our other systems has been one of the most impactful. Having systems that patients can utilize and navigate easily is very important for the success of studies. Making sure the systems are user friendly for the participant helps tremendously with the level of compliance achieved as well as how eager a patient is to complete study tasks. However, having these well-designed platforms tested and in place prior to the site activation is critical so there are no delays with enrollment. Ensuring these systems also enable direct engagement between patient and staff also contributes to retention and compliance within the study because patients are comfortable and trusting of the study team. Challenges will be part of the process So far, we have encountered only a few disadvantages when using more advanced technology systems, the primary challenge being usability among older populations. These patients sometimes have trouble navigating eConsent forms on a tablet, and I’ve witnessed a similar problem with eDiaries, which can lead to compliance issues. Regular reminders and additional support may be necessary to ensure these self-reporting platforms are used appropriately without added stress or burden to the patient. Lack of a reliable internet connection can also pose problems for some patients and certain regions. Here in Savannah, we can occasionally experience extreme weather that slows internet access. For example, we recently had a hurricane that completely cut out connection and prevented us from seeing patients due to lack of access to sponsor systems. Having a paper option on hand in case of events like this is important, but it is not necessary to avoid new technologies out of concern for challenges such as these. The value our electronic systems provide on a regular basis far outweighs the additional preparations needed during unique circumstances. Conclusion Advanced technologies at the site level are rapidly changing the way trials are conducted, making them more efficient, accurate and patient-centric. These resources also empower study teams to maximize efficiencies and improve the patient experience. As we continue to acquire new digital systems and platforms in the clinical research space, it is important to understand how these tools can and should be levered to maximize efficiencies that meet your most pressing needs. And lastly, as these technologies improve and evolve, and they will, it is vital to choose not only strong, effective technologies but also strong, collaborative technology partners dedicated to supporting evolving needs of clinical research sites, staff, patients and investigators.   By: Lindsey Marshall,  Senior Manager, Site Operations, Javara

The landscape of clinical research is undergoing a remarkable transformation, with physician assistants (PAs) and nurse practitioners (NPs) emerging as pivotal players. As the healthcare industry grapples with a shortage of doctors, these advanced practice providers are poised to step up and fill the void, bringing their unique expertise and patient-centric approach to the forefront of investigative studies. Overcoming Industry Challenges The healthcare industry is facing a critical shortage of doctors, including those involved in clinical research, due to factors such as retirements and fewer new doctors entering the field. According to the Association of American Medical Colleges the United States will experience a physician shortage of approximately 86,000 by 2036. In addition to creating a concern about access to medical care, the declining number of medical doctors poses a significant challenge to maintaining the pace of clinical development leading to new medical treatments. With fewer practitioners available to evaluate and address patients’ health problems, the number of patients per practitioner will increase and the time available to perform research will compete directly with the time needed to treat patients. The result will be a strained healthcare workforce with little capacity to innovate and bring new treatments to market. Additionally, a relatively small number of physicians participate in clinical research with a little over 32,000 PIs operating worldwide in 2020.  Compounding this problem, about 66% of physicians filling out an FDA Form 1572 never will fill out another.  This one-and-done effect attenuates the pool of potential investigators and makes the prospect for finding replacement experienced investigators increasingly more difficult. The Untapped Potential of PAs and NPs in Clinical Research NPs and PAs have the background to take on the role of investigator roles. They receive extended training in performing physical exams, conducting clinical assessments, writing prescriptions, and diagnosing diseases. They can perform these responsibilities independently or while collaborating with a physician depending on local, state, and federal regulations. Further training can be provided by implementing mentorship programs. The programs allow experienced principal investigators to guide NPs and PAs in taking on the complexities of clinical research studies. As we prepare advanced practitioners for more involvement in leading clinical trials, it is essential for sites to foster strong sponsor relationships and advocate for advanced practitioners as clinical research investigators. Advanced practitioners with experience in clinical trials are more likely to gain acceptance in senior clinical research roles when sponsors are familiar with their backgrounds and capabilities. Despite the widespread recognition of PAs and NPs’ contributions, there hasn’t been sufficient progress in attracting candidates to the clinical research field. For instance, a 2021 survey of advanced practitioners found that 97% felt that clinical trials were important and 70% expressed interest in being more involved in trials. However, only 35% of advanced practitioners have pursued opportunities in the field of clinical research. Patient-Centric Perspective One of the hallmarks of NPs and PAs is their patient-centered approach to care. They are adept at building rapport with patients, understanding their needs, and ensuring their well-being. This patient-focused perspective is invaluable in research for recruitment, retention, and adherence to protocols. Additionally, clinical research allows the opportunity for PAs and NPs to work in the field of cutting-edge investigational product development, expanding these services to diverse patient populations, and making a direct impact to the patients both sitting across from us during the assessments as well as future generations to come. Advanced practitioners’ team-oriented approaches to medical care in clinical settings are crucial skills necessary for success in the research field. NPs and PAs are often relied upon to bridge any communication gaps between patient and physician. Such communication skills are essential in facilitating successful clinical trial execution with colleagues, sponsors, and patients. NPs and PAs often provide continuity of care that extends beyond the confines of a clinical trial. This continuity fosters trust and encourages patient engagement, leading to more diverse populations and better overall outcomes in research studies. Expanding the Talent Pool To address the shortage of clinical research investigators, we need to actively engage more PAs and NPs. An important factor is to increase communication and education about clinical research opportunities while PAs and NPs are still pursuing their degrees. One helpful approach to boosting advanced practitioner involvement is through bolstering clinical research as an essential component of PA and NP education. Presenting clinical research as a viable and rewarding career path during their education can cultivate a new generation of investigators equipped with the necessary knowledge and enthusiasm. Another effective approach to increasing PA and NP involvement in clinical research is by emphasizing its importance as a core component of their professional development. Educational institutions and training programs can incorporate hands-on research experiences and partnerships with clinical research organizations to provide practical exposure. By reaching out prior to licensure, the clinical research sector could encourage more of these professionals to pursue careers in this domain. For advanced practitioners, the benefits of working in the clinical research field are abundant. For one, clinical research can offer a better work-life balance compared to traditional clinical settings. Clinical research follows a more standard schedule, allowing for a life outside of work. The role of clinical research is diverse, exposing you to various tasks daily. For instance, the role may include evaluating participants for trial enrollment, establishing a treatment plan, and providing direct patient care. These varied tasks fulfill the desire for many PAs and NPs to continue to multitask, but on an achievable level as compared to clinical practice. By delegating certain responsibilities to NPs and PAs, physician investigators can alleviate their workload and improve clinical trial participant and data oversight. This collaborative approach optimizes resource utilization and enhances the efficiency of operations. Shaping the Future of Clinical Research PAs and NPs are poised to play an increasingly influential role in shaping the future of clinical research. With their patient-centric approach, clinical expertise, team-oriented mindset, and dedication to advancing medical knowledge, these professionals are well-equipped to drive meaningful change within the industry. NPs and PAs often work in underserved communities and have firsthand experience addressing healthcare disparities. Involving them in research allows us to better understand the needs of diverse populations and develop more inclusive and equitable interventions. Currently, sponsors need to rely on the approximate 30,000 clinical investigators for successful patient enrollment in clinical trials. With more than 71,000 nurse practitioners and 125,000 physician assistants in the United States, the pool of skilled practitioners who could assume the responsibilities of Investigators with the right training is expanded exponentially. Even if 10% or less participated in clinical trials, this number of potential new investigators could substantially improve the pace of clinical research. Discover how IMA Clinical Research’s site network and experienced staff, including several PAs and NPs, can support your clinical trials. Contact us today to learn more about our innovative solutions and how we can help advance your research and bring new treatments to patients. By Alyssa Boschen, PA-C, MMS, CPI, IMA Clinical Research     Resources Association of American Medical Colleges. (n.d.). New AAMC report shows continuing projected physician shortage.  https://www.aamc.org/news/press-releases/new-aamc-report-shows-continuing-projected-physician-shortage Badu, Samuel. (2023, March 23). The role of advanced clinical practitioners in clinical research. The British Journal of Nursing. https://pubmed.ncbi.nlm.nih.gov/36952363/ Braun-Inglis, Christa. (2022, August 12). Better Late Than Never: Fully Incorporating Oncology Advanced Practice Providers into Cancer Clinical Trials. JCO Oncology Practice. https://ascopubs.org/doi/10.1200/OP.22.00224 Eggleston, Alice. (2024, July 6). PA Experiences in Clinical Trials. Journal of the American Academy of PAs. https://journals.lww.com/jaapa/fulltext/9900/pa_experiences_in_clinical_trials.119.aspx Getz, Kenneth. (2021, December 7). Tracking Change in the Global Investigative Landscape. Applied Clinical Trials.https://www.appliedclinicaltrialsonline.com/view/tracking-change-in-the-global-investigative-site-landscape Lewis, Colleen. (2022, April). The Advanced Practice Role in Clinical Trials: Past, Present, and Future. Journal of Advanced Practice. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9126353 Saunders, C. The role of nurse practitioners as principal investigators for clinical studies. Research Practitioner. https://scholars.duke.edu/publication/726443

  One of the most time-consuming aspects of clinical trials for sites is training. It’s time to bridge the disconnect between the expected and actual amount of time it takes to train. The 2024 SCRS Technology Site Landscape Survey shows a disconnect between how many hours the sponsor/CRO believed their training requirements were and what the sites reported them to be. Not surprisingly, sites reported more average hours than the sponsors/CRO respondents. The Site Landscape Survey indicated growing demands for site staff to sit through more and more training, taking valuable time away from all other study duties such as identifying participants. Prior Site Landscape Surveys indicate study staff are subject to an average of 17.5 hours per study per month spent in training.  The current Landscape Survey better quantified that by specific roles. On average, each role within a site spends around six hours per month on training, with coordinators often spending even more time. Prior to the budget finalization, sponsors/CROs should be able to provide a good-faith estimate of the number of expected hours of startup training needed. There should also be a contingency plan for the budget should the training be longer than initially budgeted. All partners are reminded that a training that “only takes three hours” but has to be taken by three people at the site is no longer three hours of site time, but nine hours. While there is little doubt regarding the need for legitimate training, the focus was more on anecdotal examples of redundancy that are contributing to increased site costs, burden and burnout. Many sites pointed out the mundaneness of watching hours of videos of people filling out sample web-based forms, pointing out the differences between text boxes, drop-down boxes and option buttons as if this kind of data entry was unique to their company. One site noted they had two similar studies using similar technology, but one sponsor’s training was 4 hours more than the other. Other stories included sites watching several minutes of training on how to set up a username and password when they had to set those up to get into the training system. These examples aren’t one-offs; they have been experienced by sites much more than one would hope. SCRS is advocating for a 25% reduction in training hours by the end of 2025, a goal that SCRS Honorary President David Vulcano believes is achievable through practical steps. Training should be “right-sized” to eliminate unnecessary duplication and focus on what is truly essential. There are many options to help make this vision a reality: Allow for Training Reciprocity: Encouraging training reciprocity between sponsors and CROs, similar to what has been done with Good Clinical Practice (GCP) training, could significantly reduce redundancy. If a site took acceptable training for one study, they should be considered trained for the others. Unless there is something really unique about the setup for the particular study, there is no reason that a site should have to take the same or substantially similar train on the same system used in multiple studies. Vendors volunteered that they could assist with this in providing system-specific certificates of training instead of study-specific ones.  Sponsors and CROs indicated they could definitely be more cognizant and accommodating of this.  Sites indicated they could be more willing to call out when they are being required to do repetitive training. Focus on Role-Based Training: Sites generally appreciate more modular-based training specific to roles as opposed to general training for all staff. Sites will immensely benefit by only having their recruitment staff take the recruitment training but not the data-entry training, for example. Embrace Just-in-Time Training: All parties recognized that training drift is a real phenomenon and that requiring training too early can be problematic.  The general consensus was that while much training was essential to be delivered prior to engaging in the protocol, some could be deferred until after the protocol started so that the burden and time required at startup could be decreased. The examples were all protocol specific, but the concept can apply to more content than one thinks. Focus On Site Needs/Q&A Instead of Pre-made Decks:  Sites often complain that they have to sit through site initiation training on things like the lab manual and then are provided with the lab manual to read at some point after the training and then Q&A happens on things the training didn’t address. It is seemingly more efficient to provide the materials for review prior to site initiation and the time can be better focused on the Q&A. Utilize Pre-training Test-outs: For those who can demonstrate competence in a particular area or with a particular system, should not be subject to training just to “check the box” that they took it. Provide the option to test out and only require the training if they fail to test out or, as always, require retraining later should there be a for-cause issue. Reduce Unnecessary Retraining: Sites gave numerous examples of how they had to sit through mandatory retraining because of other sites’ mistakes. To solve this, sponsors and CROs can consider more risk-based or targeted “mandatory retraining”. The decision to require retraining should be data driven based on performance at the site or even at the individual level. Solicit Site Feedback: Sponsors and CROs should actively seek feedback from sites on the usefulness and relevance of training materials, allowing for continuous improvement. Streamline Training Content: By focusing on essential information and cutting out superfluous content, training can be made more efficient without sacrificing quality. Given these examples, it should not be a substantial undertaking to cut site training burden by at least 25% in the next 12 months. SCRS challenges sites and industry partners to work collaboratively to achieve this goal.    

The 2024 SCRS Global Site Solutions Summit brought together 1,700 clinical research leaders to explore new approaches to enhance site performance and patient outcomes. The four-day event brought together research sites, sponsors, CROs, and solution providers to foster new insights and partnerships through an in-depth look at real-world challenges in site operations. The theme for the 2024 Summit – “Partner for Progress, Innovate for Impact” – served as a central focus for our discussions, sharing challenges and opportunities for improving the clinical research ecosystem. On Wednesday, SCRS hosted a Hidden Costs of Conducting Clinical Trials workshop, a foundational learning experience showcasing strategies for calculating true study costs and negotiating fair budgets with sponsors and CROs. The Summit officially commenced on Friday with insights from the annual Site Landscape Survey, innovation showcases from Site Spark award finalists, and inspiring stories from patients and sites. On day two, plenary sessions focused on how to transform research for greater inclusivity, followed by additional insights from the Site Landscape Survey. 40+ breakout discussions were hosted on Saturday, covering topics such as business development, patient recruitment, workforce management, regulatory guidance, DEI, legal considerations, and more. Ken Getz, Director of the Tufts Center for the Study of Drug Development and Research Professor at Tufts University School of Medicine, kicked off the final day of the Summit. Getz highlighted evolving challenges and opportunities in the clinical trial landscape, particularly with rare disease therapies, rising costs, and growing complexity. Trends, Challenges, and Opportunities In his keynote presentation, Getz noted several industry trends such as increased layoffs, budget constraints, and global volatility impacting clinical trial startups and overall drug development. A prominent challenge impacting today’s trials is the complexity of protocols, data volume, and the growing use of multiple data sources. These factors have contributed to longer trial durations, increased patient burden, and higher failure rates in studies—particularly in rare diseases and oncology. Further complicating the landscape is the increasing customization of trials, driven by small biotech companies and CRO partnerships. This has led to a high volume of site feasibility assessments, resulting in an estimated $350 million spent by sites last year on qualification processes, often without securing study grants. To address these challenges, Getz identified three key optimization areas: patient engagement, data management, and risk management. By focusing on integration, cross-functional collaboration, and continuous monitoring, there are opportunities to reduce risk, share costs, and better engage critical partners like sites and patients. Additionally, a shift toward shared risk models between sponsors, payers, and patients was suggested as a path forward to meet the increasing complexity of clinical trials. Getz emphasized the urgent need for the industry to seize opportunities to embed clinical research into patients’ broader healthcare journeys and utilize AI, real-world data, and novel trial designs to enhance data collection and operational efficiency. Trial Complexity and Timelines A key obstacle raised throughout the Summit is the complexity of trial protocols, which drives the need for more assessments and specialized site requirements. Additionally, the lack of standardization across portals and systems further complicates the process, creating a fragmented experience for sites. There is a call for greater data interoperability and better integration of systems to simplify site management, but progress remains slow. From a sponsor perspective, there is sometimes an urgency to “fail fast” in clinical trials, particularly in high-risk phases. Sponsors are often forced to accelerate timelines in response to portfolio risks, which can place sudden, high-pressure demands on sites. This dynamic illustrates the broader issue of miscommunication between sites and sponsors regarding the risks and pressures each party faces. The role of site engagement and relationship management teams was also recognized as critical factor to improve site-sponsor collaboration. Feasibility Clinical research sites face overwhelming time demands of feasibility questionnaires and qualification visits. A striking observation was that site staff spend about a week per month on these tasks, diverting valuable time away from supporting trial participants. Sites are often asked for the same information repeatedly, so it’s imperative that we continue to streamline repetitive processes and invest in better systems to reduce this time burden on sites. Site time spent on feasibility assessments could be streamlined or reduced if sponsors and CROs find ways to utilize existing site data. Innovation and Technology Integration  Sites are increasingly leveraging technology to improve efficiency. Many sites discussed the adoption of electronic data capture (EDC) systems, telemedicine solutions, and other digital platforms that have streamlined site management and patient interactions. The role of artificial intelligence (AI) and data analytics in predicting patient enrollment trends and improving trial outcomes is also growing substantially. The use of digital tools to engage patients was a recurring theme. Investing in the latest tech for patient recruitment can enhance study visibility, though it’s imperative to recognize that technology solutions may not suit every study or patient demographic. Understanding patient preferences and tailoring approaches to meet their needs is a key first step. By integrating patient feedback into trial design, we can ensure that studies are patient-friendly and responsive to their concerns. YPrime’s Aubrey Verna remarked that we’re in a state of “Frankensteined” technology where sites struggle to manage multiple disjointed systems. She pointed out that technology should simplify, not complicate, site workflows. Seamless integrations, such as API solutions, and better partnerships can simplify the user experience for site staff. Further, there is a prominent need to reduce the number of vendors and align preferred vendor lists between sites and sponsors to further minimize bottlenecks. SCRS reiterated the call for sponsors, CROs and vendors to reduce site technology training requirements by at least 25% in 2025. Training should be “right-sized” to eliminate unnecessary duplication and focus on what is truly essential. This goal can be accomplished by switching to role-based training, deferring training until after protocol startup, allowing for training test-outs, and allowing for training reciprocity among sponsors and vendors. If the goal is to reduce site burden and improve site operations through unified, user-friendly platforms, it’s imperative to involve sites in technology decision-making, development, and testing. Early engagement with sites during protocol reviews can create alignment and reduce ambiguity with technology-enabled trials. Moreover, technology implementation budgets need to account for indirect costs, such as time away from patient care, and ensure risk mitigation to avoid further burdening sites. Sites, sponsors, CROs, and vendor partners can work together to improve processes end to end. As always, system and process improvements should be balanced with the need to focus on supporting the people who drive clinical trials forward – sites and patients. Record Retention Some sponsors and CROs continue to obligate their sites to retain study records for years or even decades beyond regulatory obligations. Sites have clearly expressed that they do not want to take part in long-term record archiving, and the industry collectively agrees that current budgets are not adequate for long-term storage. Ironically, the 2024 Site Landscape Survey showed that only 21% of sponsors and CROs feel sites are “very competent” in meeting the demands of long-term electronic record archiving. It’s recommended that sponsors work with their own storage vendors to keep study records, taking this burden off of sites and allowing secure access to files when needed. Diversity and Inclusion There is a need for culturally competent recruitment approaches, especially to make trials more accessible among diverse populations. Training site staff on cultural sensitivity and awareness to build trust with different patient communities. To start, sites are encouraged to promote a diversity-first hiring strategy that attracts candidates with a range of skills and backgrounds. Community outreach funding is also essential for enhancing inclusive research, although it has been challenging to include under traditional marketing budgets. Further, developing long-term partnerships with community organizations that serve underrepresented groups has helped increase research participation and improve trial inclusivity. Workforce Although the state of the site workforce has improved compared to prior years, attendees collaborated on ways to bring more site staff into the ecosystem, along with improving training and retention. Proper onboarding and creative benefit structures were highlighted as essential to reducing employee turnover and meeting cultural demands. Creative benefits that align with the cultural and personal needs of employees can further reinforce engagement. Onboarding and training are vital for ensuring long-term staff engagement and reducing turnover. A well-structured onboarding experience fosters a sense of belonging and enhances performance from the start. Sites should develop thorough onboarding processes with targeted training programs that address specific roles, helping new employees integrate smoothly. Alison Liddy from IQVIA also emphasized the importance of bringing new investigators into the fold, partnering with sponsors to ensure these sites have the tools they need to succeed, and preventing them from becoming “one-and-done” investigators. Investigator training and mentorship are crucial for developing the skills needed to lead effective clinical trials, where the guidance of seasoned study coordinators and mentors can help new investigators navigate challenges. Training should balance clinical knowledge with practical business skills, covering essentials such as Good Clinical Practice (GCP) and regulatory processes. There was a call for sponsors and CROs to invest in new, research-naïve sites by offering infrastructure support and avoiding common pitfalls like underpaying or overwhelming these sites with complex processes. This includes funding investigator training, which increases preparedness and reduces turnover. Innovating for Impact Partner for Progress, Innovate for Impact: our hope is that this theme is not just words, but the core of what we achieve together in 2024 and beyond. The connections, ideas, and collaborations we form will drive the progress we are collectively striving for and create a lasting impact on our industry. The work ahead requires working together with evolved purpose, collaboration and, of course, action. It’s remarkable to think of the progress our industry made together at the Global Site Solutions Summit and the transformations to come. Our collective achievements are possible because of the partnerships we build, the challenges we face, and the solutions we pursue to solve those challenges together. Let this be a reminder that when we unite with purpose, we don’t just progress – we transform. Thank you for your contributions and commitment to making a difference. We hope to see you again soon.

Far too often, the very patients who need breakthrough treatments available through clinical trials are the same patients who face significant barriers to participation. Among these, financial concerns and logistical hurdles are predominant. Addressing these challenges is crucial for increasing engagement and retention among diverse patient populations. Reducing patient burden doesn’t just benefit participants; it also contributes to more successful trial outcomes overall. By enhancing the patient experience, clinical trials achieve higher retention rates, leading to consistent and reliable data, reduced recruitment costs, and timely study completion. When trial design starts with a people-first approach – where both patients and research sites thrive in a more supportive and efficient environment – everyone wins. Understanding Patient Burden Participating in a clinical trial often comes with a range of pain points for patients. Financial anxiety is a primary concern, as costs related to travel, accommodation, and time away from work can weigh heavily on potential participants. A 2022 survey revealed that 55% of respondents cited cost-related considerations as influential in their decision to participate in a trial. Additionally, according to the American Society of Clinical Oncology, 18% of patients considering a clinical trial reported out-of-pocket costs as a potential barrier, and 20% were concerned that insurance would not cover their treatment. Alleviating Financial Concerns When patients are assured that their participation will not lead to financial strain, their commitment to the trial increases. Here are some strategies to consider: Engaging Patients Through Understanding Beyond financial relief, patient engagement is crucial for retention. Understanding and addressing patient needs can significantly enhance their trial experience. Collaborative Efforts in Reducing Patient Burden Collaboration is a powerful tool to alleviate patient burdens in clinical trials. By fostering partnerships between research sites, sponsors, and patient advocacy groups, these stakeholders can tap into shared resources and knowledge to create a more supportive environment for participants. Shared Resources and Expertise Collaborative efforts allow for the pooling of resources, such as centralized travel services or shared technological platforms, which can streamline processes and reduce costs for all involved. This can lead to more consistent and reliable support for patients, ensuring that their logistical and financial concerns are effectively addressed. Knowledge Exchange Through collaboration, stakeholders can share valuable insights and best practices. For example, patient advocacy groups can provide firsthand perspectives on patient needs and preferences, guiding sites and sponsors in designing trials that are more aligned with participant expectations. This knowledge exchange enhances the trial experience and can lead to more patient-centered protocols. Coordinated Efforts By working together, sites and sponsors can implement coordinated strategies that address patient concerns holistically. This might include joint initiatives for patient education, streamlined communication channels, or integrated support systems that simplify the trial process for participants. Improving Trial Outcomes Ultimately, these collaborative efforts can significantly enhance trial participation and retention. When patients feel supported and valued through coordinated efforts, their commitment to the trial increases, leading to more robust and reliable research outcomes. A collaborative approach to trial design ensures that reducing patient burden becomes a shared responsibility, benefiting all stakeholders involved and paving the way for successful trial results. Streamlining Trial Operations By focusing on reducing patient burden, clinical trials can improve their overall efficiency and success. Streamlined operations not only enhance patient satisfaction but also reduce site workloads, allowing staff to focus on core research activities. Alleviating patient burden is both beneficial for participants and transformative for clinical trial operations. By addressing financial concerns and enhancing patient engagement, research sites can foster higher retention rates, leading to more consistent data and successful trial outcomes. The symbiotic relationship between patient experience and site operations ensures that both parties benefit: patients receive the support they need, while sites enjoy reduced workloads and improved efficiency. By prioritizing these strategic improvements, clinical trials can achieve both operational success and significant advancements in healthcare – making trials more inclusive and effective for all stakeholders involved. Explore Scout’s innovative services to reduce barriers to participation and increase retention through enhancing the patient experience at scoutclinical.com. Contributors Courtney Dodge, Director, Strategic Initiatives KimberLee Heidmann, Executive Vice President, Patient Experience and Customer Success Eva Wilson, Content Writer

In clinical trials, patient compensation through reimbursements and stipends is vital for the patient experience. Reimbursements cover travel and meal expenses, while stipends are fixed amounts paid for the time and effort involved in participation. Delayed payments can prevent patients from continuing in studies, impacting their access to critical treatments and the overall study outcomes. Additionally, the non-medical financial costs, such as loss of income and financial instability – often referred to as financial toxicity, can severely affect patients, particularly those with cancer. Research sites act as the interface between patients and sponsors, but managing reimbursements and stipends can create significant time and resource burdens. The extent of this burden depends on the level of support from financial systems provided by sponsors; manual processes are slow and prone to errors. Technology solutions from sponsors could help, but not all systems effectively reduce the burden on sites. Sponsors must recognize the challenges involved, as understanding these is essential for implementing the best solutions. Typically, the reimbursement and stipend processes involve various internal stakeholders, including those in finance, operations, and legal. Ultimately, aligning the differing expectations and needs of patients, sites, and sponsors is crucial for creating a best-in-class experience for everyone. The Patient Experience Each patient is unique; their circumstances, medical needs, and preferences shape their clinical trial experience. The challenge is ensuring that each patient has an exceptional experience. Clinical trial stakeholders should proactively seek feedback from patient advocates. Engaging with diverse teams of patient experts representing various therapeutic areas and personal and professional experiences can drive patient-centric and empathetic technology design. Feedback has uncovered common themes, including:● Need for intuitive design● Accessible help and support● Data privacy and security Being listened to, feeling cared for, and comforted throughout the study are foundational to the patient experience. Patient Compensation In U.S. studies, stipends are more common than reimbursements, and patients should be informed that these payments are treated as income by the IRS. Stipends can also disqualify patients from other government benefits like Medicaid and the Supplemental Nutrition Assistance Program (SNAP). Payments above the $600 threshold require patients to pay taxes and receive a 1099-MISC form fromthe payer. The proposed Harley Jacobsen Clinical Trial Participant Income Exemption Act seeks to remove this tax liability, which affects an estimated 110 million Americans enrolled in social welfare programs, enabling them to participate in clinical trials without risking their benefits. Impact of Manual Processes or Inadequate Systems Late payments are not uncommon in clinical trials, with reimbursements or payments sometimes taking months to process if suboptimal processes and systems are used. From a system perspective, patients are interested in solutions that offer:● Choice in disbursement options● On-time payments● Visibility into the payment process● No hidden bank or card fees● Simple patient registration● Local language and timezone support The Site Experience Research sites play a crucial role in clinical trials, managing various responsibilities such as study setups, patient recruitment, and compliance. Their connection with patients significantly impacts the overall experience, as they provide support, build trust, and keep patients informed. Sponsors supply sites with technologies intended to streamline processes, but using multiple disparate systems can create burdens, including:● Multiple user interfaces● Increased logins● Data entry duplication Sites also seek support for patient reimbursement and stipend processes, including expense verification, receipt management, and addressing patient inquiries about unpaid reimbursements. These challenges can lead to a domino effect on operations, often triggered by a single unpaid receipt. While sites appreciate supportive technology, they need pragmatic solutions and increased visibility in payment processes. The financial challenges faced by sites are well-documented, highlighting the importance of addressing reimbursement and stipend issues, as they directly affect all stakeholders in clinical trials. The Sponsor Experience Sponsors need a holistic approach when determining the best strategies and infrastructure for successful clinical trials. Insights from the ISR survey reveal sponsors’ expectations regarding patient reimbursements, budgeting, and financial management services. Sponsors must support patients and sites without overwhelming them with technology, whilst not providing an underwhelming,demotivating experience. Effective systems implementation relies on aligning strategic, philosophical (patient and site-centric), technical, operational, and functional requirements. According to the ISR survey, 86% of respondents preferred an end-to-end clinical trial financial management solution that includes:● Budget planning● Forecasting● Contract negotiation● Payment tools● Expense tracking A unified platform designed with these features offers significant advantages over multiple disparate systems. Patient Reimbursements and Payments – More than Expense Management Understanding patient reimbursements and stipend systems is not only about software, transactions, workflows, and data management systems. It is about people – patients, caregivers, and sites. Adopting a truly patient and site-centric approach is the secret to delivering the exceptional experiences needed to create an optimal environment for study success. Contributors Medidata

Rare disease clinical trials pose unique challenges for research sites, sponsors, and patients alike. With smaller patient populations, complex logistics, and specialized treatments, success requires thoughtful planning, collaboration, and flexibility. Drawn from industry best practices, these strategies help rare disease trials succeed. 1. Make Collaborative Planning a Priority Rare disease trials often involve complex protocols, stringent eligibility criteria, and small patient pools. For these trials to succeed, a collaborative relationship between clinical sites and sponsors is essential. Inclusion and exclusion criteria should be carefully reviewed to avoid unnecessarily excluding patients from an already small pool of eligible participants. Additionally, contingency plans should be put in place in case of any logistical challenges. At the same time, clinical sites must be proactive in communicating challenges and proposing solutions. This might involve recommending the use of decentralized trial elements and other variables to make participation easier for patients. Proper resourcing is also critical. Sites must have adequate resources—sufficient staff, equipment, and support—to handle intricate trial protocols and patient needs effectively in rare disease trials. By ensuring clinical sites have the infrastructure, personnel, and technological tools, sponsors can prevent delays and inefficiencies. 2. Partner With Advocacy Groups and Registries and Online Communities When it comes to recruiting patients for rare disease trials, consider engaging with patient advocacy organizations and disease registries. These organizations can help raise awareness about trials and connect sites with individuals who might otherwise be unaware of the opportunity. Consider the case of a trial related to erythropoietic protoporphyria (EPP). EPP is a rare genetic disorder that affects only 4,000 to 6,000 individuals in the United States. Given the limited number of patients, clinical sites can turn to a resource like the Porphyria Registry Service for recruitment support. Through this type of collaboration, clinical sites can access a highly engaged community of patients, offering a direct line to potential study participants. Social media platforms, disease-specific forums, and patient-centric apps are also valuable resources for recruitment and engagement. Researchers can connect with these digital communities before, during, and after a study to raise awareness about trials and get direct feedback from patients. 3. Provide Travel Concierge Services Geographic location is one of the biggest hurdles when working with rare disease populations. Patients often need to travel long distances to participate in trials, which can be a significant burden. Clinical sites can mitigate this challenge by partnering with sponsors to simplify travel coordination. When sponsors and sites work together to handle arranging a patient’s flights, accommodations, and ground transportation, it removes logistical stresses that make it easier for patients to participate in the trial. By eliminating these barriers, sites ensure that distance does not become a disqualifying factor. 4. Adopt a Patient-Centric Approach It’s also important to acknowledge what you’re asking of patients. When patients must travel great distances or make other significant sacrifices to participate, clinical sites should ensure the experience is as accommodating and supportive as possible. Providing travel plans well in advance allows participants to organize their schedules, secure time off work, and make necessary personal arrangements. Offering flexible appointment times, including weekends and evenings, further demonstrates respect for their time and commitment. As rare disease trials often require repeated visits, it’s vital to maintain open, empathetic communication. When unforeseen circumstances arise, such as abnormal lab results, patients should not be burdened with additional travel unless absolutely necessary. Instead, sites should explore alternatives, such as using home health services for routine procedures like blood draws to reduce the inconvenience for patients. 5. Build Relationships for Long-Term Retention Patients with rare diseases are often motivated by more than just the potential benefits of the trial; they frequently want to contribute to advancing treatment for their condition. Clinical sites should leverage this motivation by fostering positive relationships that encourage referrals and long-term engagement. Creating an exceptional patient experience leads to higher retention rates, and even the potential for referrals. When patients feel supported, they are more likely to refer friends, family members, or others in their community to participate in future studies at a site. Offering clear communication, flexible scheduling, and personalized care throughout the trial helps to build trust. This is critical for patient retention in any clinical trial—especially in rare disease research, where every participant counts. 6.  Utilize Expanded Access Programs Expanded Access Programs (EAPs) allow patients who are not eligible for clinical trials to access experimental treatments outside the trial environment. Offering EAPs as a component of your rare disease research strategy can increase visibility and engagement while providing treatment options for patients ineligible for trials. This also helps sponsors gather additional safety and efficacy data in a real-world setting. 7.  Offer Genetic Testing and Counseling Rare diseases are often genetic, and many patients may be unaware of their specific diagnosis. Providing genetic testing and counseling services can help identify eligible patients and ensure they fully understand their condition and the potential impact of participating in a clinical trial. This is particularly valuable for diseases that may have multiple genetic variants. Driving Success in Rare Disease Research Successfully conducting rare disease clinical trials requires a strategic, patient-focused approach that goes beyond standard practices. Clinical sites that prioritize the needs of patients—through tailored support, logistical solutions, and strong partnerships—are better positioned to overcome the unique challenges posed by rare disease studies. From working with advocacy groups to streamline recruitment, to offering flexible travel accommodations, these elements support patient engagement and overall trial success. At the same time, clinical sites need to have the right resources. With the necessary infrastructure and tools available to conduct efficient, patient-friendly studies, well-equipped sites are better positioned to manage the complexities of rare disease trials. For deeper insights into how clinical sites can refine their approach to rare disease trials, stream this recent SCRS podcast episode. By Hamish Baird, President & CEO, Remington-Davis

Outlining five strategies to ensure mandated requirements for diversity in oncology clinical trials are not just met but become a cornerstone of clinical trial operations for better patient recruitment, retention and outcomes.

Systems that are readily accessible at the click of a button are indispensable assets for clinical study sites to efficiently manage and execute essential tasks. As the number of systems grows for each sponsor, what initially appears as a boon can quickly become burdensome due to a multitude of challenges, leading to poor user experience, delays in study startup and operational inefficiencies.

Clinical research professionals are full of great innovative ideas, intentions, and desires. What usually lacks is running the playbook to turn ideas into company action, at scale. You still must do the hard work of socializing, problem-solving and pulling the right levers so that the idea becomes embedded in the organization and lives beyond your day-to-day involvement.

Clinical research is a highly regulated field with insurmountable amounts of data to process, and AI can support and simplify daily tasks for clinical research coordinators (CRCs). Depending on the needs of your role, experimenting with some basic AI tools as a clinical research coordinator may make your job just a little easier!

The future of clinical research is a connected user experience with automated workflows, streamlined document exchange, and transparency to accelerate studies without compromising compliance.

Is patient engagement becoming the newest industry buzzword? We think so. When speaking to people who work in the industry of managing clinical trials, it is clear that the concept of patient engagement is relatively undefined, thus allowing for ambiguous definitions to flourish. For some, it is any activity through which patients and participants in clinical trials are engaged. For others, it is how we collect data from clinical trial participants, be they patients or caregivers. We will focus on how to support clinical trial participants in a way that enables them to feel fully invested in the clinical trial they have decided to join. Purposeful patient engagement is essential in shifting a participant’s feeling of solely being “data donors” towards feeling like valued partners in our scientific discoveries. This is a critical component to the success of not only clinical trials but also the advancement of access to healthcare for everyone, everywhere. In viewing the engagement component as necessary, this white paper aims to define and benchmark the meaning of patient engagement to avoid marketing jargon and misinformation. By reading this white paper, you will learn the following: What purposeful patient engagement looks like in the context of clinical trials What patient engagement is and what it is not – how to see past buzzwords and recognize true engagement tactics and strategies The potential impact of behavioral science on patient engagement The benefits of deploying a patient engagement strategy and how to overcome challenges The components required for success and best practices for deployment By Datacubed Health

Clinical trials are a crucial step in bringing new treatments and therapies to patients, but the lack of diversity in trials – which leads to incomplete data and limits the generalizability of results – often delays or derails the process. Legislation can help address diversity gaps in healthcare research by creating legal requirements and establishing penalties for non-compliance. The U.S. government has already taken steps with its recent guidance and omnibus bill, which will require diversity action plans for any clinical trials presented to the FDA for late-stage approval. But pharmaceutical companies mustn’t wait for government guidance to become law to transform their clinical trial processes. Developing a successful diversity plan requires time and planning. Two critical elements of a successful diversity plan are: (1) Specifying the goals for enrollment for underrepresented ethnic and racial participants, and (2) detailing a specific plan of action to engage and enroll diverse participants. Recruitment of diverse patients is, without a doubt, the biggest obstacle hindering clinical trial diversity. The clinical trial recruitment process has always been painful, long before DEI was a factor. Adding these requirements makes it even more difficult. Overcoming Recruitment Challenges Four key factors impact the ability to successfully recruit diverse patients for trials. My company, H1, refers to these as the “ABCDs” – awareness, burden, confidence, and disqualification. To start, many minority groups are not even aware of clinical trial opportunities. Patients might be willing to participate but have no idea how or where to turn for information. This can be solved through communication and education within the community. Then there is the burden of participating in trials, including taking unpaid time off, travel, and caregiver commitments. Pharmaceutical companies can offer ways to make it easier for patients to access trial sites and participate, whether it’s a hybrid approach, reevaluating site locations, or offering stronger financial reimbursements. Conducting trials within underserved communities – or at non-traditional sites such as community health centers and pharmacies – can help relieve some of this burden. All patients, but especially minorities, have a general lack of confidence and trust in the pharmaceutical industry. Being transparent with patients about the process and taking authentic steps to be inclusive can build trust back. Pharmaceutical companies should make connections with community leaders, employ diverse investigators and staff who reflect the communities they are serving, and invest in underserved communities on an ongoing basis – whether through public health education programs or giving back in other ways. Finally, in many cases, minority patients are unintentionally disqualified from clinical trials due to stringent inclusion and exclusion criteria of the trial design. Meant to measure the effect of the treatment on “the ideal patient,” disqualification often occurs due to comorbidities and potential drug interactions. This is a big reason why sometimes, despite a company’s best efforts, diverse patients still aren’t being reflected in trial results. Pharmaceutical companies can take steps to improve criteria and minimize disqualification as part of their diversity planning. If the pharmaceutical industry can be more aware of these factors impeding clinical trial recruitment and participation, then they can transform the process to make it more inclusive. Three Things The Future Holds The pharmaceutical industry needs to put diversity at the center of everything it does. And, to be truly equitable, it needs to be tackled on a global level. I predict that the following three factors will fuel a massive transformation in clinical trial diversity over the next three to five years: A period of learning as more drugs are denied and consequences are understood: We are already seeing the FDA reject drug approvals due to a lack of diversity in trials. As the omnibus bill becomes law, we’ll no doubt see more. We’ll learn about what makes a good diversity plan, what happens when a plan is successful, and perhaps more importantly, what happens if a plan is unsuccessful. And notably, the industry will have open conversations and collaborations about these learnings to support improvement as a whole. Technology will accelerate faster than you can say “clinical tri…”: Technology is already moving at a break-neck pace, and it isn’t slowing down anytime soon. With the rise of AI and advanced data science, tech will accelerate at such a pace that it will help us in ways we can’t even imagine. But one thing we know is that new technologies will enable pharmaceutical companies to get their medications and treatments to all patients faster, safer, smarter, and more equitably. Big data will play an integral role in fueling global trial diversity: The evolution of how we collect and analyze clinical trial and patient data will influence the future of representation. The U.S. might be an early adopter, but we’ll soon see how different countries adopt new clinical trial strategies. This collective data will yield insights that will continuously improve the process. For example, pharmaceutical clinical feasibility teams can tap into granular diversity data beyond patient demographics and down to the indication and disease level to uncover diversity gaps in current clinical trials and make the process more representative. While ensuring diversity throughout the drug lifecycle – from clinical trial design to commercial launches – is the goal, the reality of achieving it is complex. Federal intervention requiring the recruitment of diverse patients in clinical trials is the right move. This is a huge step forward and, by leveraging the right data and collaborating, pharma can have a great impact on the future of global health equity. By Ariel Katz, CEO & Co-founder, H1

In recent years, much has been made of the proliferation and use of digital tools to enable patient identification and matching to clinical trials. But within the everyday world of a busy investigator site, how useful are these tools? In this case study we examine a real-world, practical example of the significant time and resource savings that can be gleaned by the application of such tools. THE CHALLENGE COHORTS For an observational multi-center cohort study on metastatic hormone-sensitive and castration-resistant prostate cancer, a database was created capturing patient characteristics, disease features, clinical outcomes, and healthcare utilization insights through chart review. To date, 19 centers have been included to create a national “Real World Data” registry, with the number of participating hospitals increasing annually. 19 HOSPITALS Data for this multi-center study were previously collected manually, a time-consuming and costly task. In addition, the data captured only reflected a snapshot in time. To update insights, manually re-gathering data per hospital would be required, which limited the speed and scope of the study. A suitable alternative to this time-consuming, error-prone, and irregular process of manual data collection was sought. THE SOLUTION The use of digital patient-finding technology enabled the automation of the data collection process. Data could be collected simultaneously from multiple hospitals through a process that adhered to all data privacy considerations. The deployed technology was able to search through both structured and unstructured Electronic Health Record (EHR) data. Natural Language Processing algorithms (NLP), embedded in the technology, extract the medical concepts and measurements from the clinical notes and pseudonymize the data. After this, the data from various sources is harmonized and loaded into the database. The search set-up (query) was refined and improved several times during the project, based on characteristics and symptoms of the patients already identified. Figure 1: IQVIA, Navigating Treatment Outcomes, 2023 THE OUTCOME IMPACT ON HEALTHCARE Provide faster, more effective and continuous feedback to healthcare providers about their care delivery and its impact on the treatment of patients. WIDER INSIGHTS As well as gaining rapid, accurate insights into clinical outcomes and complications, the cost-effectiveness of treatments can be determined for the cohort. ACCURACY ASSURANCE Greater assurance about collecting an accurate, error-free and complete set of data in the cohort database was obtained by: • A direct download from the Electronic Health Record (EHR) instead of manually retyping data • Automatically unlocking all relevant data fields, which often does not happen during manual searches HEALTHCARE COSTS As well as gaining rapid, accurate insights into clinical outcomes and complications, the cost-effectiveness of treatments can be determined for the cohort. TIME-SAVING Not only is this way of searching faster than manual searching, it is less error-prone, more data can be found and the data provided is of a higher quality. THE NUMBERS • A registry of 10,000+ patients generated in less than 2 years • Reduction of patients that needed to be screened for inclusion by 53.2% • Completeness and accuracy of automated data extraction 92.3% or higher • Identification, validation and completion of extracted data in 105 minutes per patient with patient finding technology, versus 300 minutes during the manual process (65% time saved) • 32,500 hours of work saved, corresponding to 17.4 FTE and 1,023,333 euros saved THE USER OUTCOME “By using this software, we can find patients and collect their data much faster than is possible with manual data collection. This allows us to give the information back to healthcare professionals and society faster, to improve patient healthcare.” — Principal Investigator “Before using this software, it took five hours per patient to manually transfer all the data into this database. By automating data collection, huge time savings were made, it now takes less than two hours per patient.” — Principal Investigator For a more detailed examination of the benefits of this technology, IQVIA has published a white paper, “Finding All the Needles in the Haystack;’ Technology-Enabled Patient Identification for Clinical Trials”. Download the white paper here.