Have you ever wondered how clinical research sites are awarded studies? The process isn’t as simple as you may think. Some of the most common ways to obtain a study would be through Investigator Interest Questionnaires, automatically generated invites and referrals.
An Investigator Interest Questionnaire, otherwise known as a feasibility survey, is self-explanatory; any person from the site can manually go to the pharmaceutical company’s (sponsor) website and input their Investigator’s information to be entered into a database for selection or consideration based on the information submitted. These days web portals such as drugdev.org make this process even easier.
Additionally, automatically generated invitations can also be sent from the sponsor to the Investigator based off of therapeutic expertise and enrollment fulfillment through participation of other previously awarded studies of said sponsor. Lastly, recommendations and/or referrals depending on previous work history or agreements with affiliated sites can be a great source of obtaining studies. Clinical Research Associates (CRA’s) can and will recommend a site depending on their personal past experiences with the site; this may be due to the overall work ethic, professionalism, enrollment capabilities etc of the site. Basically, the better the past experience was with a CRA, the more likely it is for the site to be re-selected.
Once a site is prequalified by the sponsor considering all the aforementioned processes, a CDA (confidentiality disclosure agreement) will be submitted by the sponsor to the attention of the Investigator so that additional information can be securely released to the site. Upon submission of the CDA, a protocol synopsis following and a feasibility survey will be sent out to the site. Feasibility surveys contain specific inquiries for consideration in relation to the goals set forth by the sponsor for the study to be awarded to the site.
Once all of this is completed, a 1–4 hour visit will be scheduled in order for a CRA to be sent out to confirm the accuracy of the site’s capabilities to satisfy the sponsors goals. These visits have many acronyms that carry the same meaning [e.g., PSSV (pre site selection visit), SSV (site selection visit), SEV (site evaluation visit, SQV (site qualification visit)]. The CRA’s will generally be met by a coordinator and conduct most of the visit with them. Approximately 30–60 minutes is required with the Principal Investigator for the visit. During the SSV, formal introductions will be made followed by a tour of the facility. At this time, the CRA will be observing the facility’s features (e.g., calibrated equipment, adequate/appropriate equipment, proper use of equipment, adequate space, double locked storage rooms for IP/Source documents, limited access areas, site’s standard operating procedures, cleanliness and organization) as well as the overall look and “feel” of the clinic as some of the many qualifying factors used to determine site qualification.
For the site, it is important to be professional but also give the CRA a sense of comfort and assurance that the site is suitable for participation in the protocol. After the tour is completed, the remainder of the visit will be a sit down meeting to cross reference the accuracy of the projections and
capabilities reported on the feasibility survey made by the site. This will also be an opportunity to further gauge Investigator and site interest in the trial.
The CRA will generate a report by updating the feasibility assessment and making note of observations to take back to the sponsor for final review. The questions asked by the CRA to the site at the SSV will be almost exactly identical to the feasibility survey questions. In addition, new questions might arise if interest is sparked by an unexpected answer. It is of utmost importance as a CRA and as a site to be fully prepared and transparent during the visit so that the site’s capabilities are not over or under emphasized as this can lead to the study not being awarded or even worse, the study being awarded only later to find out that the site was not suitable for participation for a variety of reasons but most typically due to the site not being able to meet the recruitment goals. Some of the bigger questions to be asked will be about the targeted therapeutic demographic, the “how’s and where’s” to ensure enrollment fulfillment, Investigator and Study Coordinator experience as well as responsibility and availability for the trial’s duration. Additionally, prior site audit disclosures, facility licensures and certifications, previous IRB experience in regard to study startup, projected turn-around times, and anything that needs further clarification should be addressed. At the end of the visit, the CRA will take all that was discussed, noted, and observed into consideration to weigh the pros and cons of the site and make an educated decision on whether or not the site is suitable for the trial.