Contributed Commentary by Nick Palumbo

December 2, 2020 | In most industries, a feasibility study evaluates whether or not a proposed project is possible to undertake or capable of being completed within a given set of parameters. Feasibility in clinical research is not much different. However, we in the clinical research service sector tend to use the term feasibility to address two very different aspects of our service: developing the project strategy and selecting investigational sites.

A strategic feasibility assessment is typically performed prior to the start of a project. The scope and analysis may vary depending upon the allotted time to perform the assessment and the objective(s) of the assessment. The importance of the strategic feasibility assessment should not be underestimated nor should it be truncated to submit to other deadlines. When performed well, it becomes the foundation of a successful project.

Meeting deadlines and achieving milestones dominate our world. As a service provider, contract research organizations (CROs) try their best to demonstrate their ability to meet these goals from proposal development through the course of the project life cycle. Most CROs perform some type of feasibility assessment to demonstrate their understanding of the project and ability to carry it out. However, most feasibility analysts are under enormous constraints to meet proposal deadlines and high volumes of proposals, which can sometimes result in cursory assessments and half-baked analyses.

A truly complete strategic feasibility assessment requires three key items that when managed correctly, creates a comprehensive implementation plan.

• Experienced analyst
• Reliable data, resources and tools
• Dedicated time allotment

The experience of the feasibility analyst is a significant differentiator in developing a sound assessment. An analyst that has extensive understanding and experience in clinical operations has a significant advantage over someone with simply an advanced degree or research experience. Does the analyst understand the patient journey? Are they familiar with the regulatory and healthcare environments in the countries under assessment? Knowing how to interpret the data and relate it to practical operational experience is critical to assessing risk, developing projections, as well as understanding how recommendations can be applied in real-life situations.

Access to reliable data and resources is, of course, the crux of the assessment. Data not only needs to be provided from trusted sources, but it needs to be able to be applied in a relevant manner. Many companies understand the importance of data-driven analyses and will invest in it and the tools to support it. The feasibility analysis needs to clearly convey what data was used, how it was applied and why it is relevant. Human resources are also a differentiator; who is contributing to the analysis and how is their experience relevant to the study?

Allotted time for the analysis is also key to success. Yes, time is required to do all things needed to complete the feasibility report. However, just as a sponsor wants to know “how many other studies is my project manager managing”, the sponsor should be just as curious to know “how many feasibility assessments is my analyst conducting at the same time”. Time to gather and organize data is one thing. Having time to critically analyze the data and form strategies is another. Most CROs are under the same time constraints in regard to submitting proposals, but an analyst with fewer projects has more time for critical analysis and creating alternative scenarios, which could benefit the study and sponsor.

Site feasibility assessments are performed during the start-up phase of a clinical trial and are part of the site identification and selection process. Site feasibility should, when done effectively, utilize the lessons and recommendations provided in the strategic feasibility assessment, in that, it is targeting the appropriate site and investigator profile, countries or regions and integrating the enrollment projections into the project plan. In addition, site feasibility can build on the data from the strategic feasibility assessment by obtaining site level data, which can help refine enrollment projections.

Whether the study is run by a CRO or kept in-house by the sponsor, efficient site identification comes with the ability to identify sites who treat patients with the target indication and have a sufficient volume of patients at or near the site to increase the potential for satisfactory enrollment. CROs who have access to medical claims data and/or drug sales data may have an advantage in targeting these sites. A complement to this tact is direct and demonstrated experience with sites who have successfully met enrollment goals. Since past performance is a good predictor of future capabilities, the marriage of these two tactics will help reduce the time to identify sites.

As site specific data is retrieved from each targeted site, the feasibility analyst should continue to refine enrollment projections and search for trends in the data from feasibility questionnaires and CRA interactions which could pose further risks. These risks could include competing studies, site capabilities related to study procedures (e.g. in-house lab requirements), environmental issues (e.g. COVID-19) or eligibility requirement concerns. These findings will be reported by the feasibility analyst to the project manager, along with recommended mitigation steps.

Finally, as sites are activated and enrollment begins, it is the same feasibility analyst who tracks enrollment data, compares it to the projected plan and determines if mitigation steps are necessary.

The best situation for a study sponsor is to utilize a CRO who provides continuous accountability of the feasibility assessment from strategic planning through completion of enrollment. The strategic feasibility assessment needs be data-driven, based on reliable data and resources, and the data must be analyzed by a feasibility analyst experienced in clinical operations and patient recruitment. They must also have the time to dedicate to the analysis. A CRO who is capable of maintaining the same feasibility analyst or team throughout the course of the project ensures a thorough understanding of the study objectives, risks and requirements, and has demonstrated its commitment to the success of the project.

Nick Palumbo has over 25 years of experience in the life sciences industry, including 20 years in clinical research. He has extensive management (department, multi-national corporate management) and project management experience with local and global teams. Nick’s experience also includes strategic planning, financial oversight, and human resource management. His personal values of “Ownership, Accountability, and Responsibility” propel his passion for excelling in customer service and exceeding client expectations. Prior to joining WuXi Oncology, Nick held senior leadership roles at IQVIA Biotech, PSI Pharma, Acurian, and Quest Diagnostics. He holds a BS in Biology from Cabrini University. He can be reached at Nick.Palumbo@wuxiapptec.com.