What Will it Take for the Industry to Accept Proof of Competence Over Experience?

Applied Clinical Trials

This is certainly a question that stimulates a great deal of debate amongst industry professionals, even those working in Pharma companies that explicitly request all CRAs working on their projects have at least 2 years? prior experience

This is certainly a question that stimulates a great deal of debate amongst industry professionals, even those working in Pharma companies that explicitly request all CRAs working on their projects have at least 2 years’ prior experience.

At a recent Think Tank meeting hosted by the International Academy of Clinical Research, attendees from across the industry came to an agreement that there needs to be some kind of universal framework against which the performance of clinical research professionals can be verified to ensure they have the right skills, knowledge and behaviors irrespective of their experience.

If changes aren’t made, and aren’t made soon, the clinical research industry runs the risk of stagnating. Continued inflexibility makes it nigh on impossible for new blood to break into the market. The comments from bioscience students regularly highlight this conundrum: “How do I get experience if I have no experience?”

We all know the time-pressured environment of clinical research, which is further compounded by the shortage of experienced staff, but the irony is that there seems to be reluctance for companies to invest time and money in training new graduates. Everyone wants to employ someone who can hit the ground running, but no one is prepared to teach them how to run. As such, talented young stars of the future are being lost from the industry.

At the IAoCR, we believe experience does not equate to competence. The breadth and depth of the ‘experience’ may be narrow– two years working on one study and only conducting monitoring visits does not necessarily make a CRA competent. Assessments also play an important role – how has the CRA been assessed, how do we KNOW they are competent? Just because someone has been working for two years, it does not mean they are good at their job in the same way that someone who has been driving for ten years isn’t necessarily a good driver!

As an industry, isn’t it time that we test for competence?  

In clinical research guidelines such as the ICH Harmonized Tripartite Guideline and the Guideline for Good Clinical Practice E6(R1) there are very general references to training:

“Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).” (ICH GCP principle 2.8).

The guidelines mention qualifications according to education, training and experience, all learning inputs. Nowhere is there a mention of the key output – competence. There is currently no set of standards in clinical research for how individuals are trained and assessed to ensure they are working to the required performance standards.

It is true that most people working in clinical research are highly qualified, and that degrees in medicine, a biological science or a nursing qualification are the norm. However none of these qualifications are directly related towards conducting clinical trials competently.

At the IAoCR, we believe that having internationally recognized and accredited clinical research professionals whose competence has been independently assessed would give both the industry and the general public greater confidence that people working in the clinical research sector are competent to fulfil their roles. Surely this is better than taking a leap of faith based upon the length of time someone has been in a job role.

We’d love to know what you think. Why not join the debate at www.iaocr.com?