In our previous article of the series, we explored the theory of site empowerment and looked at some techniques that could be applied during the study feasibility stages. This week, we turn our attention to the site selection process.
The typical process
The initial feasibility assessment process is often focused on estimating the investigator’s enrollment contribution to the study based on the protocol synopsis. Many weeks or months may pass from the time the site provided the initial responses, to when the sponsor finalizes the protocol and establishes the study budget. At the time the site is notified that the sponsor is interested in moving forward, the site may undergo a pre-study site visit (PSSV) or site qualification visit (or equivalent) based on the sponsor’s or CRO’s SOPs. Then, presuming a successful visit, the site is selected.
For many sites, this is somewhat of a passive process whereby they are merely waiting to be notified of the site selection decision, which could take weeks or months to occur. Even when notified of the need for a site qualification visit, the site merely waits for the CRA to appear and they go through the perfunctory motions to conduct a tour of facilities and review the information provided in the feasibility questionnaire.
In many cases there is no systematic follow-up by either party to assess the status, timeline or result of the feasibility assessment. In some cases the site may never hear back from the sponsor or CRO about why they weren’t selected. Were they not selected due to not having enough potential patients? Due to limited experience? Due to inadequate facilities and staffing? Or, were there protocol, investigational product or other issues that impacted the sponsor’s decision that had nothing to do with the site? The absence of such information and lack of transparency leaves the site wondering why they invested all that time and effort to submit the questionnaires, and also prevents them from applying any learnings to the next study opportunity.
What an empowered site would do
The empowered site, which determined the study was of interest and a good fit, takes matters into their own hands. Below is a list of items the empowered site does during the site selection process.
- They proactively contact the sponsor or CRO to determine the timeline and process for the site selection decision.
- They inquire if there is any further information they can provide to influence the decision.
- As recruitment potential is often a key factor driving the site selection decision, the empowered site provides an enrollment analysis of prior performance in similar studies. This “report card” supplements the information provided in the feasibility questionnaire and demonstrates how predictable the site has performed in terms of their ability to achieve timely First Patient In (FPI), as well as overall enrollment targets.
(Click here for related articles on which clinical trial performance metrics sites should be tracking.)
- Having been notified that the site has been conditionally approved pending the site qualification visit, the empowered site requests a final (or near final) protocol so they can take a closer look at the protocol in advance of the PSSV. They conduct additional internal discussions, identify aspects of the protocol that require further clarification and send this to the CRA in advance of the PSSV. The empowered site wants to ensure that they have what they need to move forward, even before the sponsor approves them.
- Anticipating that the CRA will ask more information about the enrollment potential, the empowered site conducts a more detailed review of the eligibility criteria and conducts further enrollment validation activities (e.g., EMR search, sample chart reviews, etc.) to update their enrollment estimates. They may even prepare a preliminary recruitment plan to illustrate how they are thinking about supplementing their own pool of patients with recruitment from external sources.
Rather than a “box checking” exercise, the site qualification visit is a dynamic discussion between the site and CRA about the interesting and potentially challenging aspects of the study that could impact ultimate site performance. Instead of a one-sided activity where the CRA is assessing the site, the site has the opportunity to re-visit the study based on a more complete set of information, and reaffirm their interest and willingness to move forward with the trial.
By now we hope that we have piqued your interest in adopting new and different ways of interacting with sponsors and CROs!
View our webinar, Site Empowerment – Envisioning New and More Effective Ways to Work with Sponsors and CROs for more information on the theory and practice of site empowerment.
Check out the next article where we address the topic of site empowerment during the study start-up process.