Industry-wide CRA turnover has remained at about 25 percent for the past few years, and it does not look like this number will improve anytime soon.
A major reason for extreme CRA turnover is the work environment created by CROs. Constant travel and strict schedules at sites has dehumanized the profession, undermined the ability to take ownership of relationships, and inadvertently fostered a checklist-driven monitoring style. This “industrialization” can be toxic for sponsors and investigators who are passionate about helping their patients.
Yet, when choosing a CRO, investigation of the potential partner’s internal culture is not often a high priority. Environments that lead to high CRA turnover can undermine productive partnerships, as instability and low employee empowerment begets preventable quality issues, delays, and cost overruns.
“We need to emphasize a CRA-centric culture, not just KPIs, to build a win-win partnership,” said Paul Bishop, Chief Executive Officer at Atlantic Research Group (ARG). “Yet many organizations are combating CRA turnover by simply escalating benefits, rather than addressing the underlying causes.”
“To set up a clinical trial for success, we have pioneered unique policies to empower our CRAs,” said Bishop. “As a result, the annual CRA turnover rate at ARG has been less than 4% for the last decade. This has created a culture of quality and strong ties to site staff of which we’re very proud.”
CRA-centricity to drive quality in rare disease clinical trials
CROs that empower CRAs can generate tremendous value during rare disease drug development, as sponsors are typically not afforded the luxury of oversubscribing trials. Every patient matters — there is no room to stall recruitment due to disengaged relationships with sites.
An invested CRA is needed to not only build rapport with site staff, but also to think creatively about solving patient recruitment and retention issues in rare disease, which plays a pivotal role in keeping a clinical trial on track. CRAs with this mindset can only come from CROs that give CRAs ownership over their work.
“It’s about treating CRAs as valuable partners and listening to their insights, such as extending a visit by a day to accommodate extra training, as opposed to regarding them as customer support representatives who do the bare minimum during site visits,” said Bishop.
CRA-centricity in action: A case study
Engaged CRAs can be the catalyst needed to turn around stalled recruitment. For example, a large CRO struggled for years to recruit patients to a Phase III efficacy study for neurogenic orthostatic hypotension (NOH), a rare disease that causes a sudden drop in blood pressure upon standing. At the time, it became clear that the conventional “large market tactics” used by the CRAs were leaving many patients unidentified and sites insufficiently supported to identify them.
Meanwhile, the company approached ARG to conduct its adjunct Phase III safety study. ARG encouraged it's CRAs to think outside-the-box. Eventually, the CRAs realized that these undiagnosed patients were actually floating around in various neurology, cardiology and Parkinson’s disease clinics, simply because doctors could not explain their aberrant blood pressure. Moreover, an attentive CRA heard a comment from a site nurse that it was difficult finding NOH patients who met the protocols inclusion/exclusion criteria for blood pressure because they were not equipped with proper stethoscopes.
Recognizing this, ARG set up sites at these various clinics and equipped all site staff with stethoscopes with the proper sensitivity to accurately measure blood pressure. As a result, the NOH safety study was able to meet enrollment deadlines in just four months. Furthermore, the success of ARG’s safety study helped reinvigorate the struggling NOH efficacy trial, which saw a spike in patient enrollment immediately thereafter all the way to study completion.
The best partner for your clinical trial in rare disease is one that not only understands the nuances of rare disease drug development, but also balances patient-centric models with a CRA-centric philosophy. Download Critical Considerations for Rare & Orphan Disease Trial Planning: A Question-First Approach to Rare Disease Studies to learn more.
