The CRA is dead... long live the CRA! The evolving role of the trial monitor

10-Dec-2015 - Last updated on 10-Dec-2015 at 15:38 GMT

How will the role of the CRA evolve in the next five years? Photo - nonmim/iStock

Could the advent of technology herald the end of the clinical research associate (CRA) within five years? One industry expert believes so.

Both Quintiles and Icon have expressed concerns about retaining clinical research associates (CRA), and recent studies have further encouraged the notion there is a “war on talent” within the contract research industry.

But such a ‘war’ may be futile as CRAs could be extinct over the next few years as trials become more patient-centric, and embrace instant data collection and analytical technology, according to one industry expert.

Head of Global Clinical Development and Operations at Grunenthal, Graham Belgrave, believes the changes in trial dynamics means “considerably less time will be spent at trial sites” over the next five years and “the future of the CRA as a role is something that will probably cease to be.”

Dead not buried

Belgrave comments, which he made at the Partnerships in Clinical Trials (PCT) conference in Hamburg, Germany last month, provoked considerable reaction.

Fellow attendee Gerald DeWolfe, CEO of CRA Assessment - who admitted if Belgrave’s prediction is correct his firm’s pre-hire CRA assessment simulation offering “would also be dead” – offered a different opinion.

“In my experience, the people attending the meetings are normally the innovators and forward thinkers and this can lead to unrealistic projections of what is to occur,” he told Outsourcing-Pharma.com.

“There are many components of data/study conduct across the 6000 or so active studies at any given time that can’t be collected by this new tech or won’t be collected due to the cost. Therefore, my assessment is that the overall impact to the CRAs by this new patient centric approach will be fairly muted over the next five years.”

However, a shift to remote monitoring systems would have an impact on the numbers of CRAs, he said, and the industry could see a 10-20% reduction in total number of CRAs.

Evolving Role

But the CRA function has already changed according to consultant Irina Colligon who told us that, in many cases, the job has merged with that of trial monitor.

“When I first got involved with clinical ops (in the 1990s), CRAs were involved in study design and reporting, not just dealing with the sites,” she said. “Small programmes had therapeutic area-based CRAs while larger programmes had product-based CRAs.”

Now, she continued, monitors are less on the medical end and more region-based, but risk-based monitoring (RBM) “may actually cause the return to the product/TA-based model, as the main reason for the regional model was to reduce costs.”

But as for the ‘death of the CRA,’ Colligon said “while remote data capture may change how the job is done, the actual job will not go away. One still needs to know that the site is real, not virtual.”