Clinical Investigational Sites enjoy working with some sponsors better than others. Top-producing clinical sites are highly sought after in an industry where there are literally tens of thousands of new clinical trials per year. Sponsor competition—whether directly or via clinical research organization (CRO) remains fierce and hence sponsors seek to attract and retain the best sites for their clinical programs. It can be the difference between a successful trial and costly failure.
CenterWatch recently released the results from its 2019 Global Clinical Trials Site Relationship Benchmark Survey. CenterWatch declared that they surveyed 4,000 participants involved with clinical sites worldwide. TrialSite News principals have engaged with sites over the years from study-start up and collaboration systems to patient recruitment. If the CenterWatch results are in fact representative of the preferences and desires of sites the results indicate some interesting observations and point to the need for the industry to perhaps “look in the mirror” and start thinking about collectively ramping up certain skills, capabilities and competencies worldwide.
Clinical research associates (aka Monitors) are really important. They represent the sponsor during a trial and conduct site monitor visits. At 66 percent, sites placed paramount importance on professional, knowledgeable and well-trained monitors/CRAs as the most important sponsor attributes. Also, at 66 percent, the sites desire their sponsors to be “organized and prepared.” Sites seek quality protocol designs (63 percent); followed by good “open communication” (61 percent); establishes realistic timelines (60 percent); “responsive to inquires (60 percent); hires and trains professional staff in clinical ops (59 percent) and “works effectively with CROs (57 percent). Setting realistic timelines was new to list.
Quality CRAs Key for Success
A quality guru colleague emphasizes the importance of “vocational certainty” when it comes to quality outcomes in any profession. This means that a professional truly understands the ins and outs of their chosen profession. With specificity they can tell you not only what they do but the how and the why they do what they do to achieve excellence in their profession. With outsourcing over the past decade, not to mention rapid growth and complexity of clinical trials, many sponsors lost some of their best CRA/monitors—they either got promoted to “project managers” overseeing CROs or moved to CROs. Many retired and perhaps new generations haven’t been trained at the same levels although some CROs have wonderful training programs.
Some outlets have reported as the number of clinical trials climbed, outsourcing contributed to a shortage of CRAs, essentially challenging the overall clinical trials sector. The risk-based monitoring movement contributed to a changing CRA landscape. Of course different CROs introduced training programs and specialized staffing agencies ramped up but there appears to be a persistent and growing challenge with ensuring that each study has excellent monitor coverage. Perhaps this influences why first and foremost sites seek professional, knowledgeable and well-trained monitors. Note the site feedback for CROs mirrored those of pharma sponsors when it comes to CRAs.Source: PR Newswire