What is clinical trial feasibility?
In general terms, clinical trial feasibility is a process of evaluating the possibility of conducting a particular clinical program / trial in a particular geographical region with the overall objective of optimum project completion in terms of timelines, targets and cost.
Who is Responsible?
Investigators must design and/or assess a protocol to ensure it has scientific merit and can be feasibly conducted at the desired study site based on the study design, access to an appropriate patient population, access to appropriate facilities/equipment, and other (financial or non-financial) resources needed. Department Chairs (or designees) oversee and approve study feasibility assessment.
What is Required?
For complete SOM Expectations: SOM Guidance for Feasibility Assessment for Clinical Research
The SOM Feasibility Industry Checklist is provided for study team use. Alternative documentation is accepted if these Four Key Areas are addressed:
- Scientific Merit – Appropriate science for the subject population; benefits department, SOM, or VCU mission.
- Institutional Resources –Qualified investigators available, study personnel, equipment, space, materials, etc.
- Recruitment, enrollment and retention – Expectations and plans to meet target accrual goals and milestones.
- Preliminary Financial Assessment – Financial resources available to cover all costs of conducting the study.