Traditional feasibility questionnaires aren’t always the most effective vehicle to determine which sites will truly be successful on a protocol. Clinical trials are often under way before the site and sponsor truly have the information necessary to ensure the study is productive downstream. This leads to a lot of work in the study start-up phase only to realize there is a deal-breaker at the end of the process, wasting time for everyone.
There are plenty of things sponsors can do to improve feasibility questionnaires, but sites can also try new ways of making the feasibility process a little more productive. From the free eBook, “Improving Site-Sponsor Relationships: Proactive Strategies for Transparent Clinical Trials,” we share a few practices for sites to improve trial feasibility.
Pick up the phone and talk to the sponsor
If you are asked to fill out a survey but you don’t have the information necessary to fully complete it, or if you want to provide an explanation on some of the answers, ask for a Microsoft Word version you can fill out or find an appropriate contact at the sponsor to actually have a dialogue about your situation. Upon receipt of the questionnaire, pick up the phone and call the sponsor or CRO before you spend a lot of time and resources completing it.
- What’s most important to answer?
- What additional information is needed to really ascertain the fit of the study?
- When will the site selection decision take place, and what will really drive the decision?
Understand the true needs and priorities of the information requested, negotiate the timelines for getting the information, provide a rationale for why more time or information is needed to truly ascertain the investigator’s interest and validate the enrollment potential, and so forth. Be vocal and decisive about what you need, why you need it and how your requests will ultimately fulfill the sponsor’s goals.
By having a clear expectation of the priorities, you can focus on the most important information and find creative ways to supplement the sometimes limiting format of the e-feasibility survey with additional information. For example:
- A summary of recommendations for making the protocol more site and patient “friendly”
- An EMR analysis of the potential pool of patients
- A summary of worst case, best case and realistic recruitment scenarios and a summary of suggested changes to the eligibility criteria that would make the protocol likely to enroll more patients
- A “standard” site profile booklet summarizing site capabilities and experience in lieu of answering redundant questions about past trials, standard equipment and staff
- A video of site facilities provided on a thumb drive or website link
By working outside of the constraints of the typical process and forms, sites can develop the trust and credibility that will set the stage for a more mutually beneficial and results-oriented relationship going forward.
Don’t just tell the sponsor what you think they want to hear
Telling sponsors and CROs what you think they want to hear rather than presenting realistic expectations during the feasibility process sets the stage for mistrust before the study even gets underway (and things often deteriorate from there).
- Don’t let the fear of not being selected lead you to undermine the situation by not being transparent about what you need to be successful.
- Be realistic about your performance.
- Communicate with the sponsor about whether patients and PIs are available or not.
- Understand what the sponsor is trying to determine and think smarter about how to get them the information that will really drive a successful protocol design or site selection decision.
Do a reverse feasibility questionnaire
Flip around the traditional approach of completing an all-encompassing and lengthy feasibility questionnaire and instead proactively ask sponsors and CROs the information you need to truly understand whether the study is a good fit. Doing this in advance can go a long way to save time and headaches later on. 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
The information you share or request in the reverse feasibility questionnaire is based on your relationship with the sponsor/CRO and their initial interest. The basic idea is to be more straightforward and transparent about what the site needs in order to be successful, while helping the sponsor or CRO understand why this information is needed and why the current process is not enabling site success.
While it may be hard to imagine sponsors being receptive to this, there are some that suggest it. 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.
The practices above can help sites complete accurate feasibility assessments and communicate their caveats, concerns and contingencies with sponsors. For more advice on improving feasibility and other topics to improve interactions with sponsors and CROs, download the eBook, “Improving Site-Sponsor Relationships: Proactive Strategies for Transparent Clinical Trials.”