The process of assessing clinical trial feasibility is in urgent need of improvement. Aimed at predicting whether a trial at a particular site will succeed, feasibility involves determining whether the site has the necessary patients, staff, technology, and other resources. In turn, site staff must decide whether the site should accept the study based on available resources.{1} The challenges of feasibility assessment are underscored by the fact that around 70% of trials have start-up delays, 80% fail to achieve on-time enrollment, and 45% miss completion targets.{2} With surging trial volumes and continuing staffing challenges, increasing frustrations are shared by sponsors, contract research organizations (CROs), and sites. Collaborative approaches are needed to improve this process.
Nancy Sacco: Feasibility remains a resource and time burden for sites
“Working on the sponsor side earlier in my career opened my eyes to the realities of sponsor expectations during the site selection process,” states Nancy Sacco, PhD, Vice President and Head of Clinical and Site Development Operations at SiteBridge Research Inc. “Now, viewing things at site level, I see the challenges faced when feasibility questionnaires and other materials come their way. Sponsors and CROs each require different documentation, which may be designed for feasibility for a specific study, or may be a general request for information about the site. The amount of effort for the site is a significant and unfair burden—feasibility questionnaires can be anywhere from 10 to 40 pages.”
From the site perspective, study-specific questionnaires are appreciated, since these are more likely to result in project wins, explains Sacco. “[Filling out] ‘pie-in-the-sky’ questionnaires about general site capabilities consumes valuable resources with little chance of business gain, and can cause frustration. These present a resource and time burden for site staff with often no response or follow-up from the requestors.”
Sacco adds that “at SiteBridge, a first-line team that oversees feasibility keeps records of all completed forms. This enables us to rapidly access earlier answers given to particular sponsor. We then focus on pulling the required patient profiling data from the electronic medical record. This helps in terms of efficiency, but there is room for improvement. Use of online versions of questionnaires could save time by including prefilled and automated options. At present, we typically receive a pdf attachment, which must be downloaded, converted to enable it to be filled out, then re-saved and e-mailed back.”
There is also a pressing need for sponsors and CROs to collate feasibility information in a format that makes the whole process more straightforward. “In an ideal world, the information sites provide for feasibility should stay in databases for future sponsor reference,” says Sacco. “Sadly, this does not happen, resulting in duplication of effort by sites and sponsors alike.”
Technology-based site feasibility databases do provide some avenues of improvement, yet miss the opportunity to provide new/frontier sites the opportunities to become successful partners in the clinical studies circle, Sacco adds. Such platforms and databases focus on historical data, leaving sites with both interested physicians and patients behind.
“Anecdotally, I’ve heard of sites drawing a line to answer feasibility questionnaires without a positive acknowledgement of the time and effort these take,” notes Sacco. “Sponsors already pay CROs to carry out feasibility services and site set-up. The process of answering questionnaires would be a good model for some ‘trickle down’ to the site work, such as a payment at an hourly rate to compensate for the time taken. At present in numerous clinical trial budgets, this time is not accounted for, yet adds up to a significant amount given the number of feasibility questionnaires that are sent out.”
This professional acknowledgement of how important sites are to clinical studies would go a long way toward keeping physician-researchers and site staff engaged—helping build a relationship from an early point and likely increasing the willingness to work with a given sponsor or CRO in future, concludes Sacco.
Andrea Bastek: Site Enablement League members share experiences and drive change
In one effort to improve feasibility, a working group has been set up by Florence Healthcare’s Site Enablement League, notes Andrea Bastek, PhD, Vice President of Innovation at Florence Healthcare. “With more than 70 member organizations, the league brings together clinical trial leaders from research sites, sponsors, and CROs,” she explains.{3} “It aims to enhance the trial site experience and drive industry-wide change through technology, process improvements, and best practices.”
The working group was inspired by a recent paper by the American Society of Clinical Oncology (ASCO), concluding that feasibility assessments are “costly, inefficient, unnecessarily burdensome, and resource intensive.” The ASCO paper added that “these methods delay trial start-up, act as a barrier to site participation, and ultimately reduce timely patient access to clinical trials and novel treatments.”{4}
“As we talked through the various issues, it became clear that people on all sides were not aware of other stakeholder challenges with feasibility,” says Bastek. “There was a clear need to align on the major challenges, why they happen, and what downstream impacts they cause. Often, problems are attributed to the site feasibility process, without a full understanding of the downstream impact of decisions.”
Bastek adds, “When sponsors or CROs try to rush site selection—with the goal of reaching first-patient-in as rapidly as possible—they may start the feasibility process before the protocol has been finalized. Site responses may then become invalid if there are protocol changes, causing delays due to renegotiations of contracts or budgets. A different upstream decision—for example, waiting till the protocol is finalized before initiating feasibility—might avoid downstream delays. Site feedback on the protocol could be obtained via a consulting engagement rather than by too-early initiation of the feasibility process.”
The working group’s output was a checklist of factors to consider during feasibility, including how to avoid challenges by having the right information upfront. The group concluded that feasibility approaches do not need to be standardized, but should take account of the impact of upstream decisions on other stakeholders. Broader awareness is needed of the fact that the process could be faster if more time was allowed for the initial steps.
“We have made considerable progress thanks to this open interchange of perspectives not related to specific business decisions,” according to Bastek. “It is rare to have a forum of this kind. Next, we plan to raise awareness of the challenges of feasibility and how they arise. We aim to recruit sites to review, test, and provide feedback on the working group’s findings so that the checklist can be further improved.” More information on how to sign up is available from Bastek at andrea.bastek@florencehc.com.
“In conclusion, the process for assessing feasibility is costly, time-consuming, and necessary,”{5} says Bastek. “With appropriate steps to refine and improve this process, there is potential for stakeholder benefits, including improvements in meeting milestones such as study startup, enrollment, and completion.”
Victor Chen: Steps toward time-saving master agreements
“At Kaiser Permanente, our infrastructure differs from those of academic institutions, so we need to approach feasibility and startup differently,” says Victor Chen, Managing Director of the Clinical Trials Program at Kaiser Permanente. “We have a total of 21 centers in northern California, with research under way at most of them. As a result, we need a very detailed understanding of sponsors’ study requirements to determine whether we can participate in a given study. For example, we need to see the protocol, the lab manual, and the pharmacy manual, and we must understand fine details such as how the study drug is formulated and how it should be stored. We find that some sponsors approach us with fully baked information, while smaller firms often have less experience and learn during our interactions.”
Collaboration and communication are vital to avoid wasted time on either side, according to Chen. “Larger sponsors may have multiple therapeutic divisions that do not necessarily share information about sites,” he notes. “Development of a standard set of feasibility criteria would be a great help in avoiding duplication of effort. An inventory of information relating to these criteria could then be made available to sponsors and CROs.”
As a step to improve efficiency, Kaiser is working with certain major sponsors to develop master agreements covering issues such as intellectual property and indemnification. “Once in place, these can be time savers for everyone, helping expedite contract finalization and study startup,” Chen explains. “We already have a master agreement in place with a device company, and this has been a game-changer in minimizing ongoing budget negotiations. Another element that would be helpful is a centralized institutional review board.”
Working with Florence Healthcare’s Site Enablement League has been “eye-opening,” says Chen. “Together, we are helping the clinical trial ecosystem move forward based on a more unified voice for stakeholders and a better understanding of each other’s perspectives,” he adds.
Amy Bland: Multiple technology platforms are cumbersome for sites
“Our clinical research department at Baptist Health Institute is relatively new, having been set up only three years ago, and we have seen many changes during that period,” says Amy Bland, Director of Clinical Research at Baptist Health Institute for Research and Innovation. “Like all study stakeholders, we need to ensure compliance. We also need to understand how best to protect our site’s interests during negotiations with study sponsors.”
Bland agrees that the Site Enablement League set up by Florence Healthcare has been very helpful. “I’ve really appreciated the mentorship of senior staff at well-established sites,” she notes. “This mentorship has provided fresh ways to look at issues such as study startup. For example, we’re faced with the need to log in to multiple systems, each with a different password. This is cumbersome for everyone—most of all, the busy physicians who oversee our research in areas such as advanced heart failure. Single-sign-on would be an excellent step forward. It would also be helpful if we could provide all sponsors with a standard feasibility questionnaire describing our sites’ capabilities and providing our assessment of feasibility rather than completing separate sponsor forms for each potential study.”
Fixing Feasibility: Collaborative Approaches for Redefining and Improving Site Selection
Join Andrea, Victor, Nancy, and Amy at ACRP 2024 [May 3–6; Anaheim, Calif.], as they consider how the frustrations shared by sponsors, contract research organizations (CROs), and sites alike underscore the need for innovative approaches to data collection and site selection that will lead to successful trials. View complete schedule.
Her department is involved with trials at multiple hospitals in Arkansas, so it needs to develop separate documentation for each hospital, adds Bland. “This process is currently under way, with the goal of saving time and minimizing bottlenecks in the feasibility process,” she explains.
Bland adds that knowing that other sites are also assertively advocating for their interests has empowered her department at Baptist Health Institute to do the same. “We have also learned more about how to appropriately delegate activities to various site roles, such as regulatory specialists and study coordinators,” she says. “In future, the Site Enablement League checklist will be extremely helpful as our department grows, helping to streamline processes and achieve further efficiencies.”
References
- https://florencehc.com/blog-post/mastering-the-clinical-trial-feasibility-process/
- https://www.clinicalleader.com/doc/is-your-site-selection-process-optimized-0001
- https://florencehc.com/press-release/florence-healthcare-announces-the-launch-of-the-site-enablement-league-to-accelerate-clinical-trial-innovation-and-enhance-site-experience/
- https://ascopubs.org/doi/10.1200/OP.20.00821
- https://florencehc.com/blog-post/mastering-the-clinical-trial-feasibility-process/
Edited by Jill Dawson
