Guest Column | December 26, 2017

Do We Need Competency Standards For Clinical Researchers?

By Jim Kremidas, executive director, Association of Clinical Research Professionals (ACRP)

Do We Need Competency Standards For Clinical Researchers?

For clinical researchers, patient-centricity is not a buzzword. It reflects a commitment to patients. They should always be at the center of everything we do.

Sometimes, in the midst of hectic workdays and meeting the increasing demands on our time, it can be easy to forget. We cannot let that happen.

Earlier this year, I had the opportunity to discuss the importance of raising the standards of professionalism of the clinical research workforce with our colleagues at CenterWatch. (CenterWatch is a source of clinical trials information for both clinical research professionals and patients.) After spelling out why ACRP believes it is so important to help drive this change and giving some examples of how new standards could improve workforce performance, we turned to the issue of public trust in the clinical research enterprise.

Frankly, we see too many variables in the clinical trials industry, starting with training and development for the people who roll up their sleeves and do the bulk of the day-to-day work. We suffer from variances in how we identify, train, develop, and assess professional competency. Variances are problematic because they can undermine performance consistency.

Now more than ever, much is expected of clinical research professionals. New technologies are entering the market at a dizzying pace. Regulators are changing the landscape in ways almost unimaginable even a few years ago. Patients are demanding a more proactive and central role. In each case, there are new things to learn and new challenges to address.

Unfortunately, our staffing mind-set is not keeping pace with market realities. The problem is most acute, perhaps, for entry-level personnel. Put simply, there is no standard path for becoming a clinical researcher.

Our industry is getting squeezed at both ends of the professional spectrum. On the one hand, there is a significant shortage of clinical research associates (CRAs). However, we struggle to integrate new professionals in the workforce because we are dragged down by an arbitrary requirement of two years of experience rather than using any measure of validated competence.

You wouldn’t want the mechanic working on your car to get the assignment simply because he showed up for work for two years. No, you’d want him to be industry-certified with proof he had mastered the latest skills and best practices.

Competencies based solely on tenure discourage a potentially talented pool of new CRAs. How can you enter a workforce that wants you to possess two years of experience first? Instead, entry should be based on demonstrated skill sets as regulated by recognized training and certification.

Today’s ragged approach is demonstrably inadequate to meet an increasingly growing need for new skills and talents. We need new CRAs, study coordinators, and other professionals while we ensure incumbent personnel are keeping pace with new standard operating procedures and other performance metrics.

Thankfully, we are well beyond the days of terrible clinical trial scandals such as the Tuskegee syphilis experiment abomination decades ago. That said, we must continue to demonstrate clinical trial integrity and inspire more patients to join us on the shared journey toward treatments and cures.

We need to know the people conducting clinical research protect patients and demonstrate competency and the high standards patients deserve. Unfortunately, that’s not always the case.

If you look at the training programs within sponsors and contract research organizations, there is a vast variance across them. There’s really no way to know who is doing a good job and who isn’t. The variance is even greater at the site level.

It’s Business 101 to say that in any type of quality initiative, the greater the variance, the greater the probability of error. When we set a standard methodology and competency level for clinical researchers who come into the industry, it will reduce the variance and improve workforce quality.

The clinical trials industry would benefit—from a perception perspective, for starters—if patients had proof the investigator in their trial is not only a physician and the coordinator is not only a nurse. As an industry, we need to find a way to demonstrate each has the credentials to conduct clinical research and keep their patients safe.

If we want to improve the quality of research to one with many benefits in terms of delivering therapies to market faster, fewer errors along the way, and better patient safety results, we as an industry must come together to establish standards and monitor ourselves to make certain we have competent professionals conducting these critically important activities.

We are the ones closest to clinical trials. We should be the ones to establish and enforce standards. If we aren’t careful, however, it leaves a tempting gap for the government to intervene and legislate something without significant industry input. That’s not a good scenario for anyone.

Yes, it’s a big challenge. Yes, it will require a paradigm shift in the way we operate. However, if we are going to fundamentally improve the quality of research, we need to come together and address this issue.

About The Author:

Jim Kremidas is the executive director for ACRP, a not-for profit association that represents the clinical research enterprise. Previously, he provided consulting services for a variety of clients including support for investigator sites, academic institutions, sponsors, and suppliers. He was the SVP of patient recruitment at two large CROs for over six years, during which he and his teams were responsible for developing and implementing patient enrollment strategies for global clinical trials. Prior to that, he spent 24 years with Eli Lilly and Company, including in leadership roles in clinical trial patient recruitment and retention, outsourcing of clinical development projects, selection and establishment of relationships with direct-to-consumer and professional advertising agencies, and implementation of standardized processes for the development of marketing materials.

He is on the advisory board of the Center for Information and Study on Clinical Research Participation (CISCRP), a nonprofit organization focused on enhancing patient participation in clinical trials, and is also a volunteer for the Clinical Trials Transformation Initiative (CTTI). He is a frequent presenter at industry conferences, and his articles/papers have been published in a wide variety of trade journals.