March 4, 2019
Many medical practices and clinicians explore the possibility of participating in clinical research studies, but half of the principal investigators who participate in one study never participate in a second. Meanwhile, other investigators continue to add studies and build successful clinical research teams within their practices. So, what do high-performing clinical research sites do that make sponsors return to them again and again?
1. They invest in infrastructure.
While a medical practice participating in its first clinical trial may be cautious about the number of resources to allocate toward the preparation required to conduct clinical research, it’s essential to recognize that clinical research and medical practice are fundamentally different. True preparation for research requires staff training, a realistic assessment of the tasks and associated human resources necessary to conduct research and the commitment to maintain those resources for the duration of the study.
High-performing sites have staff with time dedicated to research, which in busier sites means full-time research staff.
2. They hire clinical research coordinators with strong management and interpersonal skills.
The clinical research coordinator (CRC) will often make or break a site’s performance. The most successful coordinators are those with strong management skills who thrive in a multitasking environment because they will take an active rather than passive role in managing research studies. Sponsors want to work with sites that take an active role in managing the progress of their studies and control timelines whenever possible.
Strong interpersonal skills are critical to providing research participants with a positive experience during their study participation. Effective communication with study team members, including the sponsor and partners providing additional support and services, also leads to the constructive collaboration that is a characteristic of all successful sites.
3. They use data and information to support research activities.
Too often, when asked how many potential subjects they will see who meet study eligibility criteria, sites will make an educated guess based on thinking about who comes to the practice for treatment. Sponsors have learned that these guesses are rarely accurate. Site teams should work within their institution or practice to determine how they will identify and reach out to patients who may be potential research participants well before the enrollment period starts. Sites also can also ask what resources the sponsor can provide and engage with those resources at study launch to maximize enrollment.
4. They are open to collaboration and new ideas.
Some processes and practices work well and have been honed over time to be efficient and successful. But many practices are ingrained due to habit or ease of use, and it’s time to entertain new ideas to improve and accelerate study enrollment. Sponsors are well positioned to support clinical sites with new ideas for study enrollment. Sites that are open to new ideas and new collaborations take advantage of the resources offered to them. Experienced sites also ask sponsors for what they need — sponsors often are happy to provide additional support to keep a study on track.
5. They don’t overpromise.
Multi-center (and multi-national) clinical trials often involve dozens of research vendors and partners, regulatory agencies and submissions and oversight committees. When sponsors plan study timelines and resource projections across an entire study, they want to base their project plans on assumptions that are as accurate as possible. At the start of a clinical study, sites are asked to estimate how many subjects they will enroll, and 68% of sites fail to meet their projected enrollment target. It’s not solely because sponsors want the highest enrolling sites; it’s also because the inaccuracy of the projections impacts the entire study. To get the necessary sample size, another site will have to enroll even more participants, or the study timeline gets pushed out.
Similar considerations are made for meeting important study deadlines. For example, when study data needs to be entered and cleaned due to a database lock for an interim analysis, one site missing the deadline because the staff doesn’t have time to answer data queries holds up the entire study. A sponsor would rather have a site that makes realistic projections about their ability to enroll participants and meet study timelines (or asks for assistance when necessary), than a site that overpromises and doesn’t deliver, even if both sites end up with the same enrollment and timing.
6. They recognize that they are part of a larger team.
Although some sponsors facilitate and encourage sites to communicate with each other, it’s not uncommon to only have direct communication from the site monitor.
This can make it hard to remember that your site is part of the larger effort and part of a giant team that includes study managers, medical monitors, partners who provide study drug and randomization systems, the IRB and safety monitoring committees — all doing their part to keep things running smoothly and provide answers to study questions in a scientifically rigorous and ethical way.
Participating in clinical trials as a research site can be difficult, especially when sites are not prepared for the needs of research studies, research participants or the ways in which research differs from the practice of clinical medicine. But research participation is also a critically important task that allows medical practices to offer investigational options to current patients while contributing to the development of medications that future generations will rely on as well.
Lindsay McNair, M.D., is chief medical officer for WCG Clinical, Inc.
-By Lindsay McNair, M.D.