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The AIR Site Alliance serves as a blueprint for industry players to facilitate patient participation in clinical trials regardless of where they live, work, or receive medical care. The collective efforts of the AIR Site Alliance provide a practical model for making clinical research more accessible and innovative. At Genentech, we understand health inequities are complex and cannot be solved overnight. Best practices established through the creation of the AIR Site Alliance model can be leveraged across the healthcare landscape to encourage inclusive behavior, such as enrolling diverse patient groups in clinical studies and delivering medicines to patients who need them most. As the US Alliance yielded successful results, in partnership with the Roche group, we’ve expanded to seven other countries: South Africa, the United Kingdom, Kenya, Morocco, India, Nigeria, and Canada.    

Our lives have become more digital by the day. This is especially true in the healthcare space, where developing digital solutions to replace outdated paper processes increases efficiency across the industry.   Decentralization has become a hot topic in healthcare, yet despite being a buzzword in recent years, decentralization has been revolutionizing the clinical trial space since well before the pandemic.   Technologies such as patient payments, electronic clinical outcome assessments (eCOA), and electronic data capture (EDC) have all been developed to optimize clinical trial operations. However, there is still a technological gap in consent management for patients, sites, and sponsors.   Despite the significant potential of eConsent solutions to dramatically improve the informed consent process, it is crucial to consider their integration with existing clinical trial tools. Proper integrations can simplify workflow for patients, sites, and sponsors, rather than complicate them.   Complacency with burdensome paper processes To understand the need for a patient-centric eConsent solution, we must first understand the paper process of informed consent — including the challenges and consequences that come with it.  Paper consent documents are often lengthy and laden with legal jargon, making it difficult for patients to read and fully understand the terms of their participation in a trial.   For sites, sponsors, and Clinical Research Organizations (CROs), this manual process creates a cumbersome paper trail with no real-time information on consent status or enrollment information by site. Furthermore, separate consent forms for different countries and languages, version control, and protocol amendments all make paper consent inflexible, operationally challenging, and burdensome.   These complexities risk inadequate patient information and comprehension, errors at sites, or even compromising entire studies. So, why do stakeholders persist with paper consent despite these drawbacks? Trust.  The familiarity with paper consent leads stakeholders to accept its consequences — sponsors reluctant to impose new processes on sites, site personnel accustomed to using paper, and patients’ trust in paper consent can all lead to resistance against new technologies.   However, the demand for a simplified informed consent process exists, and will inevitably increase as more people are exposed to eConsent as a solution, just as it has in banking and other highly-regulated industries.   According to Suvoda’s recent general population survey on awareness of eConsent and digital signatures, 50.2% of US respondents actually prefer to sign electronically (either at home or on-site).1 Simplified, patient-centric solutions can address the problems in manual processes that many have grown accustomed to while also building trust that the solution works as it is designed to — without overwhelming the patient.  Meeting sites and patients where they are Like other areas of technological innovation, clinical trial decentralization aims to address the burdens and errors associated with manual processes without introducing new complexities. To accomplish this, we need to consider existing burdens on the coordinator, the investigator, and most importantly, the patient.   Simplified eConsent solutions are inherently patient-centric because they take into account the challenges of the end user while also making patients feel like humans rather than just another number. For example, a recent JAMA study found that improving the readability of informed consent documents — something that eConsent achieves — could increase patient accessibility.2   More recently, consumers are taking in information in short, comprehensive clips, like 30-second TikTok videos. In the near future, patients and participants could feel more comfortable through the use of embedded videos, or the use of AI to summarize or highlight terms and provide definitions as they read the document.   These technologies help return some of that power back to patients and their families, ensuring they understand what it is they are consenting to in a clearer manner. In addition to accounting for the challenges, simplified solutions give more time for investigators to focus on what matters — getting lifesaving treatments to patients faster.  Practical innovation prioritizes accessibility  Suvoda’s technology is aimed at harnessing complexity to improve clinical trials, rather than adding to it for the sake of innovation. Our approach revolves around two core principles: simplifying the innovation process and creating a unified, patient-centric ecosystem that seamlessly integrates within other eClinical tools.  When it comes to innovation, it’s what you take out that matters. Simplifying a technological solution demands a concerted effort to self-edit to avoid overwhelming users.   By identifying the issues with paper consent, guided the creation of a unified ecosystem with Suvoda eConsent— one that is elegant to manage, offers high visibility and control, and unparalleled speed and flexibility while leveraging the accessibility benefits of other decentralization tools.  When eConsent integrates with IRT, it creates a virtual “gate” so that only patients who have signed the latest consent forms are dispensed the drug — simultaneously protecting patients while reducing friction for sites and sponsors. Instead of attempting to only refine the informed consent process, Suvoda introduced a patient-centered solution coupled with administrative tools, encouraging broader adoption of eConsent.  Introducing new solutions to people doesn’t have to be an uphill battle if innovation is refocused on simplicity and patient-centricity. At the end of the day, we are here for patients — only when we all work together to better guide and influence our innovation will we be able to take the steps toward a better way.   By Andrés Escallón Vice President, eCOA Solutions, Suvoda   Sources 1Survey From Suvoda Shows Comfort with Electronic Signatures is on the Rise, Yet Healthcare Consent Still Lags.” Suvoda, April 2023.  https://www.suvoda.com/insights/all-news/survey-shows-comfort-with-electronic-signatures 2Ezekiel J. Emanuel and Connor W. Boyle, “Assessment of Length and Readability of Informed Consent Documents for COVID-19 Vaccine Trials,” JAMA Network Open 4, no. 4 (April 28, 2021), https://doi.org/10.1001/jamanetworkopen.2021.10843   Download    

Overview/Background & Context Founded in 2020, Cedar Health Research (CHR) is committed to advancing clinical research by leveraging innovative technologies and fostering excellence in data integrity. As the organization continued to scale, CHR faced challenges in managing clinical trials using multiple, disconnected systems. These disparate platforms created inefficiencies which made it harder to report on key metrics and coordinate between teams. To overcome these hurdles and improve performance, CHR transitioned to RealTime’s integrated eClinical system.   The Challenge Complexity of Updates Across Platforms and Limited Access Before adopting RealTime’s comprehensive eClinical solutions, CHR encountered several challenges using multiple systems from different vendors related to fragmented systems and workflows. Reporting delays were a significant issue, as pulling reports from multiple systems required downloading separate data sets, reconciling them, and aligning information due to inconsistent naming conventions. This process consumed several hours each week for CHR’s operations team, slowing down decision-making and reporting accuracy. Furthermore, limited access to these platforms created bottlenecks in information flow because not all team members could access critical data. This hindered collaboration and slowed down trial progress. Barriers to Effective Task Completion and Oversight Task completion and oversight were also challenging due to the diffusion of tasks across multiple platforms. It became difficult to maintain visibility on task progress and ensure timely completion. Additionally, managing multiple login credentials for different systems was both cumbersome and posed potential security risks. The Strain of Disjointed Systems Hindering Patient Recruitment Efforts Recruiting patients involved multiple unconnected systems, demanding significant resources from various departments and resulting in incomplete patient profiles within the CTMS. This fragmentation hindered CHR’s ability to efficiently leverage interested patients for current or future study opportunities. The challenges with these disparate systems included inefficient processes—managing patient interest required navigating multiple non-integrated platforms, leading to delays and increased workload for staff. Moreover, incomplete patient profiles were another issue. The lack of integration resulted in vital patient information being scattered or missing, impeding effective follow-up and engagement. Additionally, low conversion rates plagued the recruitment efforts. Despite conducting numerous community events, the absence of a streamlined process led to minimal scheduling of pre-screens or screenings and ultimately no patient randomizations from these efforts. The fragmented nature of these systems resulted in a blurred line of sight for key performance indicators (KPIs), making tracking efficiency and performance transparency a challenging and disorganized process. Ultimately, these disconnected systems impeded CHR’s ability to operate at peak efficiency. The Solution In response to the inefficiencies of using multiple systems, CHR transitioned to RealTime-SOMS, a complete eClinical solution, which combines all trial management functions into a single platform to reduce complexity and improve clinical trial site management. RealTime-SOMS is the industry’s first, complete essential eClinical toolkit including CTMS, eSource, eReg/eISF, Pay, Text, Engage! (MyStudyManager™ Participant Portal + eConsent), and a secure Mobile App. CHR also adopted RealTime-Devana for study start-up, pipeline management, and business intelligence. [blockquote author=”” link=”” target=”_blank”] “The beautiful thing about RealTime is when my operations team and I come in, we can all see the same data. Reports, budgets – it’s all there.” – MJ Hamersma, Vice President of Operations, Cedar Health Research [/blockquote] After implementing the platform, CHR immediately saw improvements, particularly in patient recruitment. RealTime’s, unified, enterprise-grade CTMS allowed CHR to consolidate all aspects of trial management, from patient recruitment to study data reporting, under one roof. RealTime delivered a centralized system where all team members could access real-time data, reports, and study updates. Reporting became automated, eliminating the need for manual data reconciliation, and KPI tracking became transparent. The system also integrated with CHR’s existing recruitment and patient engagement strategies, using the CTMS Web Application and MyStudyManager™ app to improve patient recruitment and screening efficiency.   The Results Faster Response Time to Qualified Patients/Participants Using RealTime’s Web Application, a key feature in RealTime’s enterprise-grade CTMS, the ability to manage patient profiles became even more comprehensive. What used to take about 72 hours—from building a patient profile to making initial contact—now takes one day. The system allows for detailed tracking of inclusion/exclusion (I/E) criteria and provides immediate notifications to patients about their eligibility for studies. This functionality allowed the Clinical Trial Execution (CTE) team to focus their workload on qualified patients, significantly improving response times and accelerating the recruitment process. Further, the CTE team can now easily track trends in patients meeting or not meeting inclusion/exclusion criteria, allowing them to adjust recruitment strategies as needed. Shared patient profiles within the Web App further streamlined the recruitment and improved the screening processes. This enabled faster decision-making and prequalification of patients. The app also tracks conversion rates, which helps the team measure if their outreach efforts are effective. Improved Patient Management and Study Coordination CHR also saw improvements in managing multiple enrolling studies through another key feature, the Study Progress Tab, which keeps departments and team members aligned throughout the study lifecycle. This feature facilitated better communication and ensured that everyone remained updated on study progress. The system’s Recruitment Campaign Manager is another essential feature that CHR uses in coordinating and managing patient recruitment efforts. This feature provided an integrated platform that aligned Clinical Trial Educators (CTE), Marketing, and Healthcare Professional (HCP) departments, offering clear insights into campaign activities and effectiveness. Additionally, oversight and management of advertising budgets also improved, which enabled clearer allocation and tracking of funds. RealTime-CTMS’ ability to share top-of-the-funnel metrics through Progress Notes also provided valuable insights into early engagement, further improving decision-making and collaboration across the team. Impact on Patient Recruitment One of the most impactful changes was the reduction in screening times. Using RealTime’s MyStudyManagerTM, CHR saw areduction in screening times, shortening the recruitment funnel window from 7+ days to same day, which led to faster study timelines. The ability to pre-qualify patients more efficiently also played a key role, reducing the average time to first contact by 98%. These accelerated timelines allowed CHR to take on more studies annually and increase revenue potential. [blockquote author=”” link=”” target=”_blank”]“Being able to prequalify patients has allowed us to shorten our funnel window. With the web app, our timeline has dropped down to 4-6 hours.” – MJ Hamersma, Vice President of Operations at Cedar Health Research[/blockquote] With relevant notifications sent through the app each month, patient “stickiness” and engagement were strengthened at CHR. Common notification types include new study opportunities matching patient profiles, appointment reminders to reduce no-shows, and study updates to keep participants informed of progress and milestones. Key features such as immediate eligibility feedback, a user-friendly interface, and personalized communication, all drive engagement and contribute to better participant experiences. Increased Team Productivity and Reduced Administrative Burdens Today, CHR’s team has seamlessly integrated technology into their workflow, and it has become a natural part of their daily process. The results of using a centralized platform were evident at an expo in fall of 2024 which attracted over 2,000 participants. CHR experienced the tangible benefits of improved process efficiency by establishing a consistent workflow across all patient recruitment efforts, significantly reducing redundancy and confusion. At the event, CHR’s new recruitment process led to 40 new complete patient profiles and reduced response times for web applications to just hours, improving the patient experience. Scheduling efficiency also increased, with 8 patients scheduled for pre-screening visits, and a valuable patient database was created for future trials. Furthermore, using a centralized system resulted in reduced resource demands across departments and improved patient retention with faster follow-ups. Moreover, the unified data facilitated better data-driven decisions. Ultimately, this approach improved CHR’s recruitment strategies, allowed for better analysis of recruitment efforts, and increased the effectiveness of campaigns. Altogether, by streamlining tasks like data entry, trial documentation, and regulatory compliance tracking, RealTime’s suite of eClinical solutions has alleviated much of the administrative burden for the CHR team. Instead of spending valuable time reconciling various, disparate platforms, they now focus on high-priority, value-adding activities, allowing for smoother operations and quicker trial turnarounds. Key Takeaways 160% increase in patient recruitment 98% reduced time to average contact 60 hours of time savings in patient recruitment Reduced administrative site burden Single platform for central and site-based teams Before Disconnected systems resulted in a lack of data transparency and difficult task management. Multiple platforms required managing numerous logins, making collaboration inefficient. Fragmented reporting created time-consuming manual data reconciliation efforts and delayed decision-making. After Centralized operations with real-time access to data and streamlined workflows. A unified platform for better collaboration and communication across departments. Faster decision-making and increased operational efficiency from comprehensive, automated reporting tools that eliminated manual reconciliation.   Advice for Other Sites For sites considering a transition to an integrated system like RealTime, the benefits are clear. Moving to a unified platform significantly boosts operational efficiency, streamlines processes and reduces the time spent on manual tasks. By centralizing data, the system improves transparency across all levels of operation, enabling more informed and timely decision-making. Beyond the immediate operational improvements, an integrated eClinical system also provides a strategic advantage, supporting better planning, business development, and long-term growth. For any site looking to enhance performance and stay competitive, adopting an integrated eClinical system is a smart investment. Site Profile Cedar Health Research (CHR) is a private clinical research organization focused on leveraging cutting-edge technology to enhance clinical trial efficiency and patient engagement. Established in 2020, CHR’s commitment to innovation, excellence, and data integrity positions it as a leader in the industry. The company is dedicated to advancing medical science while maintaining the highest ethical standards and providing exceptional customer service.   By RealTime eClinical Solutions

Clinical research sites play a crucial role in advancing medical science, but they face numerous challenges that can hinder their efficiency and effectiveness. According to ACRP, 70% of global investigative site staff reported that trials have become much more difficult to manage in the last five years1. From the burden of manual data entry to the complexities of managing placebo arms, these obstacles can be overwhelming. However, envisioning a future where these challenges are mitigated can inspire hope and drive innovation. Challenges Faced by Clinical Research Sites A Vision for the Future Imagine a world where these burdens are significantly reduced, allowing clinical research sites to focus more on their core mission of advancing medical science. Conclusion The challenges faced by clinical research sites are significant, but they are not insurmountable. By embracing innovative solutions and advocating for site needs, we can create a future where the burden on clinical research sites is greatly reduced, allowing them to thrive and continue their vital work in bringing new treatments and therapies to those that need it most. Become a Site Advocate:  If you are a member of a clinical research site, we invite you to join our  site insights program and use your voice to help us influence industry practices and drive positive change.   References: https://acrpnet.org/2024/10/22/discover-the-top-site-challenges-of-2024-data-and-insights-on-site-barriers-and-trial-efficiency https://www.wcgclinical.com/wp-content/uploads/2023/05/WCGs-2023-Clinical-Research-Site-Challenges-Survey-Report.pdf https://myscrs.org/learning-campus/white-papers/   By Robin Douglas, VP, Research Site Engagement, Medidata Solutions

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