As we discussed in our webinar, Trends in Clinical Trial Site Selection and Patient Recruitment, competition for clinical trial sites and participants has never been stronger. Along with an escalating number of trials, drug and medical device developers face increasingly complex trial protocols, fierce competition for patients in certain therapeutic areas, an expanding global trial landscape, and increased regulatory requirements.
During the live event, we asked attendees: In your experience, what is the most important tactic to secure high-performing, high-enrolling sites for your clinical trial?
The results of our poll:
- 69% said, “Past site productivity, feasibility, and qualifications.”
- 23% said, “Developing a comprehensive study design.”
- 5% said, “Ensuring timely monthly investigator payments.”
- 3% said other.
I have to say, I’m not surprised at these poll results. In our experience, when considering a new site for a trial, it’s always a best practice to evaluate both its productivity in past clinical trials and real-time feasibility for a new trial. Taking time to ensure that selected sites have the appropriate qualifications, staff motivation, patient population, infrastructure, and support at the outset will help secure consistent, high-quality enrollment during the course of your trial.
At Clinipace, we conduct a traditional feasibility assessment with sites, but in addition to that, we look at key indicators. Not only will we look at the actual enrollment and timelines of the site’s startup, but also we’ll conduct a planned vs. actual, meaning we look at what a site stated they had planned to enroll, then assess what actual enrollment was. At the end of the assessment, we ask, “Did the site meet the timelines we were going to need? And where can we improve as an organization? Are we giving people the right tools? Are we doing things the best way we can do it?” So, it’s really a partnership, working together, getting feedback and establishing a strategic relationship with the site and measuring performance. We have seen that even some sites are beginning to disclose their study performance on their own websites, as well.
It’s also important to note, that before starting a search for qualified sites, it is essential to have a detailed, comprehensive study design that clearly specifies the patient population, investigator specialties, personnel and equipment required for the trial.
To identify the best-performing sites that align with your study protocol, begin by searching your internal database, external databases and websites and obtaining recommendations. Maintaining positive relationships with high-quality sites will facilitate site selection. Industry networking is becoming more valuable in site selection, with resources such as LinkedIn. Industry consortiums, conferences and other industry tools can also be valuable for site selection.
For more information on trends in site selection and patient recruitment, feel free to download the slides and be on the lookout for an upcoming eBook and infographic. If you’d like to be alerted when they become available, please leave your contact information in the comments section.
Steven Thayer is the senior manager of global site management services at Clinipace.