Clinical Research Professionals

Jim Kremidas

Contract research organizations (CROs) are often the unsung heroes in the clinical trial ecosystem as a key team member in the development of new therapies and treatments they provide critical support to the pharmaceutical industry by delivering an on-call, savvy workforce that can be activated as needed during the ebb and flow of the product development lifecycle. Further, by working with CROs, drug and device manufactures can often avoid carrying a larger in-house staff.

We’re entering an exciting new frontier for technology in the CRO industry. We have, seemingly within our grasp, new tools that can extend the reach of a trial, widen patient participant populations, and deliver increased volumes of data almost unimaginable just a few years ago.

We’re also hearing a new buzzword: virtual trials. In theory, technology will make it possible for trials to be conducted remotely with an emphasis on machines and less “reliance” on clinical trial professionals to conduct data collection in-person. Ideally, the virtual trial model will free up clinical research coordinators (CRCs), clinical research associates (CRAs), and others to use their talents in different ways, such as developing improved informed risk mitigation plans and enhancing study designs.

At the same time, we are seeing a greater emphasis on trials addressing rare diseases, which in turn means smaller patient populations from which to search. We could be moving subtly toward a model where CROs end up being selected for a trial based more and more on demonstrated data skillsets and relationships with patient advocacy groups. Trials may also become more patient centric and centralized (e.g., five regional sites might handle the patients in a national trial rather than 20 disparate locations).

Earlier this year, we asked attendees of our annual conference in Nashville (many of whom come from sites) what they viewed as the “biggest opportunity for clinical research” in the future. 

The top answer? Adopting digital innovation. More than 40% selected it as their first choice, with “leveraging real-world data” coming in second at 23% and “greater patient involvement” third at 21%.

We also asked our conference attendees about their use of technology in trials. Just over 60% reported using apps in a clinical trial, while 44% said they had already used other “at-home monitoring technologies,” and 39% said they’d used wearables with clinical trial patients. Nearly a third (31%) said they had used e-consent forms.

Clearly, clinical research professionals are excited about the prospect of leveraging new technologies. However, we risk squandering that enthusiasm if we don’t establish a set of agreed upon competencies for CROstaff and others in the clinical research space.

For too long, wide swaths of the clinical trial industry have operated without clearly defined and aligned workforce competencies for each role. As we know, variance is an enemy of good quality.

Industry’s current approach to workforce planning, development, and assessment is not sustainable and is not resulting in improved clinical trial outcomes. Paying closer attention to the workforce must be a priority today to ensure the stability of the clinical research enterprise in the future, as well as the continued development of new drugs, devices, and therapies.

CROs provide a bedrock service in the advancement of new drugs and treatments. We owe it to them, to patients, and to ourselves as an industry to help support these organizations with an aligned set of competencies for each role and the right kind of training tools to ensure the highest possible quality.

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