Keeping a clinical trial on track is analogous to traversing a tightrope with the help of a balancing pole. On one side is “patient-centricity,” a philosophy that helps to ensure success by focusing on patient needs and safety. At the other end is the concept of “CRA-centricity,” which involves empowering CRAs to build close relationships with investigators, resolve complex issues and proactively guide a study to success.
Unfortunately, CRA-centricity carries little weight among CROs today. As a result, CRAs are, by and large, not empowered to perform at their best. This exerts destabilizing effects on the trial environment, making studies more difficult and expensive to run.
We see that reflected in an extraordinarily high CRA turnover rate—exceeding 25% annually. This turnover, coupled with a checklist-driven monitoring style used by many CROs, can transform trials into impersonal, assembly line-style side projects for site staff. For investigators who are engaged and passionate about helping their patients, this environment is toxic.
So what can the CRO industry do to empower CRAs, reduce turnover and foster a trial environment more conducive to success?
We must begin availing CRAs with opportunities for ownership, to have longer-term engagements with sites and to think creatively about what is right for a trial. Additionally, policies that balance patient-centric initiatives with continuous CRA skill building will help prepare CRAs for those serendipitous moments that can unexpectedly deliver tremendous value.
Investigators, sponsors and CROs alike must work with CRAs as partners, not as passive customer support representatives. Not only will this help build valuable relationships among all trial stakeholders, but it will also prevent the troubling trend of dispassionate CRAs whose talents to improve trial performance are regularly forfeited.
Guest Contributor Paul Bishop is chief executive officer of Atlantic Research Group, a CRO focused on rare and orphan diseases. In the last decade, Atlantic Research Group has contributed to the approval of many sorely needed therapies, including NORTHERA and CINRYZE. Although Paul knows the difficulties of drug development for these indications, he also understands that great things are possible when passionate people combine their strengths. atlanticresearchgroup.com.
This article was reprinted from Volume 24, Issue 04, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact firstname.lastname@example.org. Subscribe >>