infocusoct24

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