The site feasibility process has been a source of angst among Sponsors/CROs and sites for years. The process is clunky, repetitive and very time consuming for all involved. In 2021, the American Society of Clinical Oncology (ASCO) Task Force assessed the issue and concluded that there needed to be a uniform and streamlined process for Sponsors/CROs to follow that included limited and standardized questions on the Feasibility Assessments and the utilization of technology to reduce redundancies and facilitate communication among stakeholders. In response to the ASCO Task Force publication, the Avoca Quality Consortium (AQC) developed site feasibility tools, but the tools are only available with a required membership, which can be costly, and there has been limited by-in by Sponsors/CROs. Three years later, we still seem to have the same issues.  So where do we go from here?

The Site Enablement League (SEL) is a by invitation only group of representatives from sites, Sponsors and CROs whose focus is to create a more nimble, innovative clinical research environment with the goal of making lifesaving treatments available to patients faster. Recently, the SEL Task Force on Feasibility was formed to assess processes and past experiences to facilitate improvement of the site feasibility process. In their recently published paper, Redefining Feasibility in Clinical Trials: Collaborative Approaches for Improved Site Selection (Bruneau et al 2024), the task force identified 3 evolving challenges in the site feasibility process.

Challenge 1: Early initiation of site feasibility

Sites are being asked to provide detailed site feasibility information before the protocol is finalized to assist in furthering its development, to finalize Study/Protocol Feasibility and to accelerate first patient in (FPI).

Task Force Recommendation: Key Opinion Leaders (KOLs) and sites should be approached prior to completing the protocol to give their feedback and assess its feasibility. This is specifically addressed in ICH E6 R3. However, protocol feasibility should be completed prior to asking for in-depth site feasibility information.

Challenge 2: CROs that initiate the site feasibility process prematurely

In some cases, CROs are asking for very detailed feasibility assessments prior to being awarded the trial to obtain high quality sites and meet timelines for FPI. This practice can lead to inaccurate feasibility assessments and sites having to do complete re-work once the protocol has been finalized.

Task Force Recommendation: The Site Feasibility process should be completed in phases, allowing for completion of the protocol and high level site information such as site profile, capability and performance data before delving into protocol specific information.

Challenge 3: Clear and timely communication

Lack of communication during the feasibility process can lead to issues with resource allocation, timeline commitments and inefficiencies.

Development timelines drive clinical trial execution. Completing the trial start-up activities, like site feasibility, in parallel can expedite the process, but it can also lead to inefficiencies and delays if not done correctly. Engage the sites and KOLs early in the process of protocol development to obtain scientific and operational feedback. Provide the sites with at least complete drafts of the protocol, lab and pharmacy manuals when completing the site feasibility and budget processes to obtain accurate feasibility and budget information. Lastly, communicate, communicate, communicate.