Guest Column | March 27, 2024

The Results Are In — Survey Reveals Barriers & Opportunities In Site Sustainability

By Jimmy Bechtel, Society for Clinical Research Sites

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Since its inception, the Society for Clinical Research Sites (SCRS) has been gathering data to decipher the operational health of clinical research sites. At the heart of this lies the Site Landscape Survey, providing a platform for clinical research sites to benchmark themselves against peers and for industry partners to grasp the pulse of site-level dynamics. The results from the annual surveys offer a transparent look into the factors influencing sites' success from year to year, with crucial insights that resonate throughout the clinical research industry.

Sites Face Financial Strain

The financial health of clinical research sites is critical to their sustainability, but a recurrent inquiry into operating capital reveals concerning trends. While 26% of sites reported they have six months of runway, many teeter on the edge, with 10% harboring less than a month's worth of funds.

Additionally, while 33% of sites reported maintaining the same level of operating capital as the previous year, a worrying 34% experienced a decline. The financial strain faced by these sites can partially be attributed to inflationary pressures on overhead and workforce costs. With some sites only one late payment away from exiting the industry, this precarious situation underscores the urgent need for strategic financial management and support.

Despite More Frequent Payments, Delays Persist

In 2009, quarterly payment schedules were a standard practice across the industry. Fast forward to the present day, and a seismic shift has occurred, with 51% of sites now operating under monthly payment agreements — a notably positive departure from the conventional quarterly model.

However, despite this transition toward more frequent payment intervals, many sites find themselves grappling with delayed payments, even with the establishment of monthly payment terms. Nearly all sites experience tardiness of payments, but 23% of sites reported a staggering 31%-40% of their invoices have been overdue for more than 90 days. Alarmingly, 7% reported that more than half of their accounts receivables are more than 90 days past due. Timely cash flow is imperative for sustaining studies and site operations, and SCRS urges industry stakeholders to prioritize transparent and expedited payment processes to support their site partners.

Eliminating Holdback Payments

Holdback payments are still common, meaning sites don’t get paid in full until various study milestones have been completed. However, the purpose of the invoiceable closeout fee is for final study tie-ups, and there should not be any funds held back prior. Sites need cash flow during the study to run their business and trials, so withholding funds can have a detrimental effect on their operations.

Only 15% of sites said they have negotiated 0% withholding in their contracts. Currently, the most common withholding amount is 10%-14%. While some progress was made during the COVID-19 pandemic in releasing holdback funds to support sites, there has been a resurgence in withholding these funds, posing challenges to sites’ cash flow. Industry stakeholders must work together to implement fairer payment practices that prioritize timely disbursement of funds to research sites.

Enabling Inclusive Recruitment

Strides have been made in representing diverse populations in trials. While 64% of sites say they successfully represent diverse populations, 60% acknowledge the need for additional support in diverse recruitment endeavors. This support may include assistance through trial budget allocations, sustained community engagement initiatives, and access to educational resources. DEI is more than a mere checkbox — it requires a sustained investment of funds and efforts over the long term. Ongoing collaboration and investment are needed to build inclusive processes and budgets.

Industry service providers assert their commitment to DEI-focused solutions, with 75% affirming their offerings are designed with inclusivity in mind. Yet only 18% of sites report that technology has effectively facilitated diverse patient recruitment efforts. Moreover, 65% of respondents noted the prevalence of diverse preclusive language in trial materials.

Sites are taking a proactive stance in updating protocols to meet modern DEI requirements. This proactive approach is echoed by sponsors, CROs, and partners, who unanimously agreed on the pivotal role of sites’ capability in recruiting diverse populations.

Reducing Technology Congestion

As tech-enabled trials increase, there are still opportunities and concerns, particularly in the realms of risk mitigation, training requirements, and financial hurdles. Site training requirements to implement new technologies and vendors have become a prominent congestion point. In 2023, 40% of sites say they spent five to 15 hours per month per study on training, and this training is often unpaid.

While technology holds immense promise for advancing clinical research, its effective implementation hinges on equitable support, robust infrastructure, and a collaborative approach between stakeholders. Additionally, there is a pressing need for integrated and consistent technology solutions to streamline data management and reduce administrative burden at the site level.

Sponsors and CROs can support sites with technology integration by providing more robust budgets that accurately reflect the true costs associated with these trials. Service providers can enable success in this digital era with comprehensive technical support, offered in multiple languages and time zones to accommodate the diverse needs of participants.

An ideal solution for all stakeholders is to involve sites during the planning stage of a trial. This collaborative approach empowers sites, enhances their understanding of the technology, and aligns the system with their specific needs and workflows. By engaging sites early on, teams can proactively address potential errors and optimize the use of platforms and portals. This also stresses the importance of accurately assessing the performance of vendors’ products and ensuring they meet the necessary standards for both sites and patients.

Long-Term Record Retention: Proceed with Caution

Increasingly, sponsors are stipulating extensive record archiving periods extending 15 to 25 years beyond the conclusion of a study. This trend poses multifaceted challenges for both research sites and sponsors alike, necessitating a thorough examination of existing practices and the implementation of innovative solutions.

While regulatory bodies such as the FDA mandate a minimum retention period of two years for study records, a prolonged retention period presents a significant burden for research sites, transforming them into de facto record storage vendors for sponsors and CROs.

The hesitation to participate in long-term record storage by over 60% of site respondents underscores the need for training and additional resources to navigate the intricacies of effective records archiving. From hardware degradation to cybersecurity concerns, the challenges associated with maintaining electronic records over extended periods are multifaceted and require careful consideration. Sites must be equipped to manage this responsibility efficiently to avoid operational strain.

Next Steps

The analysis of the current landscape reveals a delicate balance between barriers and opportunities for site sustainability. Addressing these barriers through open conversations and leveraging opportunities for collaboration and support is crucial for ensuring the continued success of sites. SCRS has established various initiatives and events for sites and industry partners to come together and share actionable solutions for improvement in these areas.

To explore the results of this year’s Site Landscape Survey results or past surveys, visit the SCRS website or watch the recording of the 2023 Site Landscape Survey presentation at the SCRS Global Site Solutions Summit.

About The Author:

Jimmy Bechtel is vice president of site engagement for Society for Clinical Research Sites (SCRS). He is in charge of developing and executing the company's site-facing initiatives and works closely with key industry partners to build out various SCRS partnership programs. Bechtel brings experience from both the site and sponsor sides of the clinical research industry. In his site experience, he served as a data specialist, patient recruiter, and operations manager. In his pharma experience, he worked in innovation project management, encouraging a site-centric environment and creating ease for sites working with a major sponsor company.