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Adapting to the New Realities of Clinical Trials

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This guest blog post by Michael Causey comes from our partner Association of Clinical Research Professionals (ACRP).

A sometimes-daunting array of processes and technologies is putting a new kind of pressure on clinical research professionals that demands innovative training and a core reassessment of how to demonstrate skillsets, says Terri Hinkley, RN, BScN, MBA, CCRC, FACRP, Workforce Innovation Officer at the Association of Clinical Research Professionals.

“The entire clinical trial landscape is changing,” Hinkley says. “Our way of conducting clinical trials must adapt and change with it,” she adds.

At one end, escalating costs, tighter study timelines, inefficient recruitment, and other important quality issues are calling into question the efficacy of today’s clinical trial process. Drug development is taking longer and costing more money.

“This demonstrates that the process of clinical research isn’t improving,” Hinkley says. In fact, it’s not keeping pace with other advances such as technological innovations, including wearables and paperless informed consent.

Elsewhere in the clinical trial operational path, many promising technologies come with significant learning curves. In some cases, those new demands, while not always easy to meet, are relatively easy to identify. For example, innovations such as electronic data capture and electronic health records are already changing how patient data are monitored, stored, and ultimately controlled.

However, there’s also the “disrupter” element to contend with, thanks in part to new entrants to the clinical research enterprise bearing exciting technology gifts. “When new technology players come into your space, they are going to disrupt because they are not beholden to anything in terms of how we historically did clinical research,” Hinkley says.

“Something has to change,” Hinkley suggests. The solution? Training must prepare the workforce of today to thrive in the workplace of tomorrow.


The Association of Clinical Research Professionals (ACRP) is the primary resource for clinical research professionals in the pharmaceutical, biotechnology and medical device industries, and those in hospital, academic medical centers and physician office settings.  ACRP's on-demand eLearning courses equips your staff with not only an understanding of the core concepts of Good Clinical Practice (GCP) but how to put those concepts into action through a series of ongoing "knowledge checks" and real-world scenarios likely to be encountered during a clinical trial.  The courses provide formal training on the International Conference on Harmonization (ICH) Guidelines for GCP, the globally recognized standard for the conduct of clinical trials, for clinical research professionals.  Developed by leading Subject Matter Experts, the ACRP GCP training library is a collection of titles designed to train your staff on the most current standards of care.  For more information about the Good Clinical Practices training library, click here.