By Jimmy Bechtel, VP, Site Engagement, Society for Clinical Research Sites
In the evolving landscape of clinical trials, the emergence of trials with decentralized elements, or DCTs, has been met with a mix of enthusiasm and skepticism. Proponents argue that DCTs hold the promise of revolutionizing the clinical trial process by improving patient engagement, recruitment, enrollment, and retention, while potentially reducing costs for sponsors, CROs, and sites. However, as the industry navigates the transition to these new paradigms, the balance between patient centricity and financial efficiency for sites has become an important point of consideration.
At the Society for Clinical Research Sites (SCRS), we believe that patient centricity begins with site centricity. While DCTs have the potential to provide more convenience and improved access for patients, the anticipated cost savings touted for these trials have yet to materialize fully at the site level. In fact, the opposite has occurred in some instances.
Training Takes Time — And Money
There are several reasons why clinical research sites are experiencing increased costs when participating in trials with decentralized elements. One overlooked aspect is that trial participants may require extensive guidance and support to navigate new digital tools and data collection methods used in trials. Ensuring patients’ proficiency in using study technology has become an integral part of the screening process, and this additional time and effort invested by sites often goes uncompensated. It is crucial that the industry recognizes the need for adequate compensation for the time and resources invested by the site for participant technology training and support.
The amount of site staff training required for trials with decentralized elements has also increased drastically. In the 2023 SCRS Technology Site Landscape Survey, 65% of sites indicated that they are spending five to 20+ hours per month per trial on training for DCTs. That means that if a site is launching three trials in one month, the amount of DCT-related training required could be at a minimum 15 hours per month to more than 60 hours per month. That training time is often not fully reimbursed for many sites.
These initial costs and time commitments can be a barrier to entry, especially for smaller sponsors or smaller research sites because of the substantial up-front investments in technology infrastructure, data security measures, and training for personnel involved. Sites are now keenly aware of these challenges and have consistently shared in the Site Landscape Survey that the top reason they declined to participate in a DCT was due to an inadequate budget.
Cost Savings Haven’t Materialized Yet
However, the potential for long-term cost savings remains compelling. The promise of quicker patient recruitment, improved diversity in study populations, and higher retention rates can accelerate trial timelines. Reduced patient dropout rates due to logistical challenges and improved data collection through remote monitoring can also contribute to more efficient trial operations. These streamlined processes can save significant resources and ultimately accelerate drug development. However, data supporting such claims isn’t widely available yet. And still, it is critical that we continue to keep site costs in mind as we work toward efficiencies and as sites take technology into their own hands and adopt their own solutions.
Sponsors and CROs can enable sites to adopt DCTs more readily by helping ensure technology-related costs are appropriately allocated in the overall budget. Every clinical trial is susceptible to unexpected expenses, including technology troubleshooting and additional training requirements. To address these "unknown unknowns," sponsors and CROs could approve an “unexpected cost allotment fund” up to a specified dollar amount. This allows breathing room for sites and sponsors to allocate funds as needed throughout the study to account for unforeseen expenses. With this approach, sponsors can review and approve costs throughout the study to understand where the fund is being allocated.
Ultimately, sites need to be adequately compensated for the additional time needed to manage technology set up, training and its patient support needs. SCRS also encourages sites to explore the SCRS Site Invoiceables Toolkit, a detailed overview of common billable items that a site should consider when assessing costs associated with a clinical trial.
The “Tech Race” Can Mean Trouble For Sites
As technology rapidly evolves, there's a tendency for a "tech race" to adopt the latest features and tools. This can lead to a fragmented landscape with inconsistent integration and a lack of standardization, which hampers the realization of cost savings and other benefits at the site level. A crucial step forward involves finding economies of scale through consistent integration of DCT technologies. The industry must move beyond the "cold tech war" phase and focus on establishing common standards that ensure interoperability across platforms and solutions. This collaborative effort between sponsors, CROs, sites, and technology providers is essential for achieving both patient benefits and cost savings.
We all share the same goal of striking the right balance between patient centricity and financial efficiency. Patient centricity should remain core to DCTs, aligning with the broader shift toward personalized medicine. Improved patient experiences not only enhance the ethical foundation of clinical research but can also yield positive outcomes for trial sponsors.
The capability of technology to enhance patient experiences, improve recruitment and retention, and eventually drive cost savings is substantial. However, the road to realizing these benefits at the site level requires a concerted effort from all stakeholders. The industry must prioritize standardization, integration, and collaboration to build a solid foundation for sustainable cost savings while maintaining patient-centric principles.
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.