Quality Professionals Question the “Two-Year CRA Experience” Notion


Disclaimer: The views expressed by Ms. Reinhard are her own and not those of AVROBIO, nor is any description of events meant to suggest an actual occurrence at AVROBIO or any of Ms. Reinhard’s places of employment.

Sharon Reinhard

Sharon Reinhard

In a previous article, I discussed the entry-level CRA industry shortage problem and how Biopharmaceutical sponsors and CROs have created a standard of only hiring CRAs with at least two years of clinical research experience. However, quantitative research has proven no statistical association between research experience and CRA performance. In this interview, Sharon Reinhard, VP of quality at AVROBIO (former VP of R&D QA at CSL Behring and executive director of quality at Merck), discusses a qualitative perspective on the CRA shortage topic.

Moe Alsumidaie: Why does the industry expect entry-level CRAs to have two years of clinical trial experience?

Sharon Reinhard: It started with industry colleagues sharing anecdotal experiences with European inspections. Inspectors said, regarding CRAs, “these people lacked experience.” As a result of hearing about these experiences, it likely became a bit of an urban legend or soft requirement that regulators were driving this two-year requirement. However, there is no written regulation or guidance to that effect. The regulations require CRAs have appropriate education, training, and experience. It is up to us, as industry professionals, to define what that looks like and feel comfortable with the monitoring team we put in place. Biopharmaceutical companies fear receiving written citations such as a 483 or a warning letter. Given the labor shortage, I believe companies should re-evaluate this unwritten standard. The two-year requirement can fade into the past if we provide appropriate education, training, and mentoring. It is up to us to define who is qualified.

MA: Why have biopharmaceutical companies abandoned internal CRA training programs? How is this impacting CRAs?

SR: Pharmaceutical companies’ economic shifts to outsourcing monitoring to CROs contribute to the problem. As a result, many eliminated training departments. As companies eliminated their trainers, where there was once classroom and on-the-job training, it became easier to say, “We need to hire experienced people, so you don’t need entry-level training.” You can’t hand CRAs a stack of SOPs and expect them to perform the work the next day; that’s not how you train a CRA. It requires therapeutic, clinical research, and hands-on training. Providing scenario-based training and mentoring is so crucial.

MA: Does clinical trial experience guarantee performance?

SR: No, there does not appear to be a one-to-one correlation between years of experience and performance.Therapeutic expertise is needed, which not all “experienced” CRAs have. For example, What do you expect to see from your investigational drug regarding potential side effects and safety profile? What medical history do we expect to see for the given patient population? What possible complications do you expect for patients participating in a given trial? Some CRAs with 5-10 years of experience are not demonstrating great performance. Quality may not be directly tied to years of working experience. We should not make assumptions based on years of experience but need to assess an individual’s capabilities and potential. After all, we all entered this industry without experience, and someone invested in us. Some people are quick learners. Some people have strong science backgrounds and took courses on research in their undergraduate studies. Suppose we provide the necessary therapeutic, investigational product and protocol training along with co-monitoring or simulation training. In that case, we could expand the pool of eligible CRAs so those with less than two years of experience can qualify. The regulation requires training, education, and experience, not two years of clinical research experience. A college graduate with a science degree and entry-level training may be appropriately qualified. We must move away from this arbitrary “two-year prior experience” CRA rule.

MA: Have regulators ever raised CRA experience issues in your experience?

SR: In my experience, regulators only raise issues if the CRA isn’t doing their job and the sponsor hasn’t addressed the root causes of performance problems. Many companies have received citations for inadequate monitoring, yet most have hired people with two years of experience or more. So clearly, this arbitrary standard we’ve put in place isn’t resulting in the avoidance of citations. Two years of experience doesn’t automatically make someone qualified. We will have to re-evaluate an individual’s qualifications if regulators find unreported adverse events and other unaddressed GCP compliance issues during inspections. However, we should not be waiting for regulatory citations to determine if our CRAs are doing good work.Central monitoring activities can and will pick up anomalies between sites that should be investigated to determine if CRA performance is contributing. We should be actively supervising CRAs through co-monitoring visits and evaluating the quality of their monitoring trip reports.This is not to micromanage CRAs but to help guide them and set them up for success.They are on the front lines of these trials and we need them to feel comfortable and confident doing their work.Any company without a good training program for employees, whether they have two years experience or not (i.e., SOP training, protocol training, investigational product training, etc.), can likely expect monitoring issues to surface during regulatory inspections. Trials have become far more complicated over the last decade, involving far more endpoints and technology, so we need to invest in CRAs to set them up for success.

MA: How has clinical trial quality changed since you started?

SR: In my 25 years in the industry, I’ve seen a decline in quality. I hypothesize that it’s related to the lack of foundational training that used to exist many years ago but mostly vanished from industry.Regulators expect to see compliance with the regulations. They do not like to observe carelessness. The revisions inserted into ICH E6 R3 and ICH E8 R1 suggest they observe poorly written or poorly executed studies. When I joined the industry many years ago, companies had robust training programs that involved mentoring, simulations, and on-the-job observational training. This kind of training is expensive and challenging to offer while remaining profitable. However, there is significant value in those programs, and I always set up robust training programs for the studies I’ve run. It keeps the study team engaged because they feel valued, making people strive to work smarter. When people feel invested, they want to perform well.

MA: How has the pandemic affected the CRA shortage?

SR: Since COVID, the job market has become so competitive that anyone with experience is promoted faster than before and many employees on the verge of retirement exited early; someone else will hire and promote a good employee if you don’t give them the title or recognition reasonably quickly. I’m not saying we should start promoting everyone rapidly. Promotions should still be earned but we need to recognize the competitive landscape we work in. If we’ve made an investment in an employee, we don’t want to lose them to another company. So we should think about ways to keep employees engaged and interested in staying. The competitive job market combined with the industry’s two-year experience minimum, has helped create a shortage of entry-level candidates and positions. This can be solved by approaching universities, explaining that these roles exist for biology and chemistry students, and then offering training if they would like to join your company as a CRA. In addition, many college-aged students desire to travel and the exciting opportunities a CRA position offers.

MA: Can other professionals be trained to become CRAs?

SR: Nurses, phlebotomists, Nurse Practitioners, and Physician Assistants who want to work in clinical trials but lack “clinical research experience” are excellent candidates because of their therapeutic expertise and direct patient care experience. They’d be great candidates if provided CRA training. When I meet people who say they’re a nurse, pharmacists, or similar, I ask if they’ve considered entering the pharmaceutical industry because there’s so much demand for new talent. Many front-line healthcare workers no longer want direct patient care work, and they would make great candidates. I feel those of us with years of industry experience should encourage these types of candidates and can be a bridge for them by networking and making internal introductions within the industry. We need to foster bringing in the next generation of clinical trial personnel.

MA: Why can people with outside experience be suitable for clinical research?

SR: People with medical backgrounds are more likely to recognize and understand GCP issues. For example, they might see that a patient isn’t receiving medical care according to the protocol, they weren’t adequately consented, or they haven’t been administered the drug properly. Two-year nursing veterans might pick this up faster than ten-year monitoring veterans. As an industry, we should welcome anyone with scientific or medical training and provide the necessary career development and training to allow them to be successful.

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