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The more things change, the more they stay the same, especially when it comes to the clinical trial site selection process. Despite all the technological advances since the dawn of industry-sponsored research, sponsors are still facing many of the same challenges when trying to predict which sites will perform the best on their studies. Most trials continue to be extended due to low enrollment, costing the sponsor money with each passing day that is added to the “Last Subject In” date, or for each new site they need to bring on. The Pareto principle (the “80/20 rule”) still largely holds: Most of the participants enrolled in a study typically come from a small proportion of the participating sites. So how can your site prove to sponsors and contract research organizations (CROs) that you will be in that upper echelon?
The aspect of site selection that has changed most obviously in the post-COVID-19 pandemic era is the focus on diversity. Where this quality ranks in the site selection criteria will vary by sponsor, study indication, and other factors, but it’s increasingly common for sponsors to reject sites due to insufficiently diverse patient populations. It’s necessary to keep information on the demographics of your practice and the wider community on hand, as you will certainly continue to be asked about this in the future. Emphasize any positive qualities of your site regarding your connection and outreach to traditionally underrepresented groups, such as multilingual staff, cultural community events, or associations your research facility or clinic is affiliated with, or any advertising you’ve done that is geared toward specific ethnic/racial groups, age groups, or language communities.
As far as other qualities that concern sponsors during site selection, very little seems to have changed over the years. Key criteria have always included the experience of principal investigators (PIs) and study coordinators in conducting clinical trials, the size of the relevant patient population, the site infrastructure, the data quality, the enrollment history, and the length of time to complete the startup process (regulatory document completion, institutional review board submission, and contract/budget negotiation). So how can you help your site stand out in a crowd?
When completing feasibility questionnaires, try reviewing your answers from the perspective of the sponsor, and look out for red flags that may raise questions or concerns about your site. For example:
- If your site has received an FDA Form 483 (Inspection Observations) from the U.S. Food and Drug Administration or other negative regulatory sanctions, be proactive and explain what your site has done to learn from the experience and improve. If applicable, provide your Corrective and Preventive Action (CAPA) plan, and describe how you have put it into practice.
- Provide realistically attainable enrollment projections—easier said than done when you may have received nothing more than a few bullet points of study information. If you are providing an enrollment projection that may seem exceptionally optimistic, support your estimate by detailing your recruitment plan, including enrollment history from previous trials where you met or exceeded the goal.
- If asked for your enrollment history, and there are multiple studies where you missed the goal, explain why (difficult protocol, “rescue” situation, sponsor closed enrollment early, study coordinator left your site, etc.). Don’t leave an open space for the sponsor or CRO to draw their own conclusions.
- Acknowledge when you have a brand-new PI and stress their enthusiasm about participating in research and helping to bring new treatments to their patients. Other important items to highlight would be if they have any experience as a sub-investigator, experience as a physician treating the disease or condition being studied, or if they would be supported by experienced coordinators, sub-investigators, and other staff.
Additionally, don’t be afraid to ask questions and request more information about the study. The sponsor or CRO may not be willing or able to send you details until they’re interested in your site, and you have signed a Confidential Disclosure Agreement, but it’s always worth a try. This can save you from wasting time and effort applying for trials that your site isn’t qualified for, or for studies that aren’t a good fit for your site. It can also signal your level of seriousness and interest in learning more about the sponsor’s study, and that you are conscientious and not just applying to every study until you get selected.
Another tip when completing feasibility questionnaires is to elaborate on your answers and make use of any spaces for comments. Don’t just check boxes and write numbers and one-word answers. Explain your access to and connection with the patient population and provide a brief recruitment plan tailored to the specific study. Distill your PI’s bio and your site’s marketing materials into a brief paragraph that you can copy and paste into the “Comments” section at the end of the feasibility questionnaires, highlighting those items that separate your site and PI from other sites applying.
A longer-term recipe for site selection success may include diversifying your research site. For example, if your bread and butter is dermatology studies, and you are seeing fewer relevant opportunities, can you forge relationships with investigators in other specialties? Can you recruit and mentor a physician who hasn’t been involved in research to become a new investigator for your site? This can provide a foundation for stability to enable your site to weather a drought in studies for a specific specialty or therapeutic area.
There’s no magic bullet for site selection. External factors beyond your control can sometimes prevent even the best sites from making a sponsor’s list—whether it’s geographical proximity to other trial sites or an abundance of qualified sites competing for limited spaces. However, by taking strategic steps to optimize your site’s appeal, you can significantly boost your chances of being selected for studies and minimize wasted time and effort.
If your site is looking to identify more clinical trial opportunities, look no further than the WCG Site Network. The WCG Site Network has been helping clinical research sites of all sizes identify clinical trial opportunities for more than 25 years, in addition to providing administrative support, recruitment and enrollment assistance, and more. Click here to learn more about the WCG Site Network.
Author: Chris Frase, Senior Site Selection Specialist with the WCG Site Network
