In the ever-evolving landscape of clinical research, site feasibility and start-up processes remain critical yet challenging aspects that can significantly impact study timelines, costs, and overall success. In a recent episode of WCG Talks Trials, Michelle Yu, associate director of clinical strategy dove into these challenges with Trevor Cole, director of client delivery, site and strategic operations. This discussion sheds light on the pressing issues facing the industry and explores innovative solutions to streamline these processes.

The Challenges of Site Feasibility and Start-up

The site feasibility process, which often includes comprehensive feasibility questionnaires and pre-study site visits (PSSVs), is a critical step in determining a site’s suitability for a clinical trial. However, these processes are frequently burdensome, inefficient, and non-standardized, leading to significant duplication of effort and unnecessary costs.

One striking example is an ASCO survey from 2021, which found that sites spent a median of 264 hours annually on feasibility assessments. Across all sites surveyed, this amounted to nearly 30,000 hours per year. This time investment, coupled with the associated costs, is unsustainable, particularly in an industry grappling with a workforce crisis and limited research infrastructure.

Moreover, the environmental impact of these traditional practices cannot be overlooked. PSSVs, for instance, contribute to a significant carbon footprint, with a single flight from Chicago to Los Angeles generating approximately 867 pounds of CO2 emissions per passenger. This raises questions about the sustainability of current feasibility practices.

Opportunities for Improvement

Despite these challenges, there are clear opportunities to improve the site feasibility assessment process. One of the most promising approaches involves standardizing feasibility questionnaires. By aligning the industry on a set of core questions, with the flexibility to add study-specific inquiries, we can reduce redundancy and streamline the process. ASCO’s 2021 recommendations for a short feasibility questionnaire, limited to only the most critical questions, serve as a valuable starting point.

There is also a growing trend of using Preferred or Alliance sites, where sponsors and CROs can bypass PSSVs by leveraging existing relationships and data. Internal site networks further streamline feasibility by providing sponsors with pre-existing knowledge about a site’s capabilities and performance.

WCG is actively working in this space, focusing on reducing data waste and minimizing the effort required from sites to complete feasibility questionnaires. By collecting site responses organically and reusing data where possible, the burden on sites can be significantly reduced.

Industry Adoption and Barriers

While there is a growing recognition of the need for change, the adoption of these innovative solutions is not without its barriers. There are four key obstacles:

1. Regulatory and Compliance Concerns: Some organizations view PSSVs as essential for ensuring compliance, even though regulations do not mandate these visits. The industry’s risk appetite varies, which can hinder the adoption of new approaches.
2. Alignment Issues: There is often a disconnect between sponsors, CROs, and sites regarding what is necessary versus what is “nice to have.” Improved alignment is crucial to streamlining processes.
3. Lack of Industry Standards: The absence of standardized tools and guidelines for feasibility assessments continues to be a significant challenge. Despite recognizing the redundancy in existing questionnaires, the industry has yet to coalesce around a unified approach.
4. Organizational Prioritization: Feasibility innovations often struggle to secure the necessary resources and attention within organizations, particularly when competing against other priorities.

The Path Forward

The clinical research industry is at a pivotal moment. There is a clear understanding of the challenges and a growing willingness to embrace innovative solutions. However, achieving widespread adoption requires overcoming the aforementioned barriers and fostering collaboration across the industry.

Feasibility is not a finite activity—it continues throughout the duration of a clinical trial. This ongoing nature underscores the importance of reducing the burden on sites and ensuring that the feasibility process is as efficient and sustainable as possible.

In conclusion, the industry must continue to push for standardization, reduce redundancies, and embrace innovative solutions to streamline site feasibility and startup processes. By doing so, we can enhance the efficiency of clinical trials, reduce costs, and contribute to a more sustainable future for clinical research.

Listen to the full episode here. You can learn more about WCG’s approach to feasibility here.