During our January webinar, Site Empowerment – Envisioning New and More Effective Ways to Work with Sponsors and CROs, a question came in from the audience about reverse feasibility questionnaires.
Q: You touched briefly on the topic of a reverse feasibility questionnaire. Can you explain more about this process? I can’t imagine sponsors or CROs being receptive to this but I think the concept is great.
A: In the traditional feasibility assessment process, sites are often asked to complete a lot of basic information along with study-specific information about their interest and enrollment potential via a standard feasibility questionnaire. This is often done in the absence of complete information about the study and without a draft budget. I often say that any study is feasible given enough time, money and resources, but sites often don’t have access to all the information needed to conduct a “true” feasibility assessment. This is further compounded by the “hurry up and wait” approach where the site is asked to complete the questionnaire within 2-3 days, only to wait months before they hear more about whether they are selected, at which point they gain access to the full protocol (and may not reflect the original synopsis). The end result is that sponsors and CROs make a lot of decisions regarding enrollment potential and the number of sites based on preliminary site estimates, which rarely come to fruition. Or, all parties invest a lot of time and effort in getting studies through the start-up process only to find there is a mismatch between the site and the study, because the information shared along the way is piecemeal or incomplete.
The purpose of a reverse feasibility questionnaire is for sites to proactively share with sponsors and CROs all of the information they need to truly ascertain whether the study is a good fit. This may include:
- Setting expectations that an initial interest response to a questionnaire is not a confirmed enrollment commitment.
- Proactively sharing with the sponsor any “non-negotiable” contract language that could ultimately stall negotiations late in the process.
- Asking for a list of key information (e.g., study budget, EDC or CRF guidelines to ascertain data requirements and workload, etc.) that the site will ultimately need before they can truly determine whether the study is feasible from their perspective.
Sharing this information in advance with the sponsors can go a long way to save time and headaches later on.
Sometimes, the information that sites share or request in the reverse feasibility questionnaire is staged based on their relationship with the sponsor/CRO, their initial interest and so forth. The basic idea, as with all of the site empowerment techniques, is to be more straightforward and transparent about what the site needs in order to be successful, in addition to helping the sponsor or CRO understand why this information is needed and why the current process is not enabling site success.
As sponsors and CROs realize the intent and importance of this information and how it influences a site’s decision (and ultimately their investment of time and resources), all parties win by quickly moving on from studies that are not a good fit or for which budget/contract issues render the study unfeasible. You can learn a bit more about empowerment techniques during the feasibility stage by reading this blog post.