New Independent Assessment of Clinical Researchers Aimed at Protecting Public Health

PHILADELPHIA, Sept. 29, 2016 -- The National Board of Medical Examiners (NBME), one of the nation’s leading and most respected assessors of health professionals, today announced that the organization has set its sights on improving the quality of clinical research by introducing the Certification of Excellence in Clinical Research (CECR). 

With several major cases in the news about clinical trials gone awry, the new NBME exam will evaluate a clinical researcher’s knowledge, with a goal of helping to protect the well-being of trial participants, reducing delays and mistakes, and helping identify areas for improvement.

The four-hour and fifteen-minute written exam uses realistic scenarios to assess a clinical researcher’s foundational knowledge in areas such as study design, ethics and data management. In addition to a numerical score, each test-taker will receive diagnostic information about his or her performance, enabling them to help identify the need for additional training or experience.

The exam was developed with expertise from veteran members of the clinical research field, including representatives from industry, academic research organizations, contract research organizations, training and education programs, grant-funding agencies, hospital systems and institutional review boards.

“We’ve been developing this exam for two years now, with nearly 100 experts in clinical research, pharma and academia weighing in,” Dr. Peter Katsufrakis, senior vice president, NBME, said. “We’re confident the assessment will synchronously help individual clinical researchers identify areas for improvement and employers—pharmaceutical companies, CROs and sites—identify and address any major deficiencies across their clinical research teams.”

The exam has two versions – one for investigators and scientists, and the second for clinical research monitors, associates and coordinators.

“Leaders in clinical research have a responsibility to anticipate the next industry benchmark,” said Dr. Charles Pollack, director, Institute of Emerging Health Professions, Thomas Jefferson University. “We want to be confident that our clinical researchers—who are conducting research on human beings— have a strong grasp of the foundational knowledge needed to conduct safe and thorough clinical trials. The CECR tests that knowledge to be sure we’re all operating with the same universal body of knowledge.”  

Many clinical trials are discontinued due to mistakes or oversights made by the professionals managing the trials. These include errors in trial design, poor recruitment and misinterpretation of results. Pharmaceutical companies can use the new NBME exam to help assess each clinical researcher, review aggregated data trends on the strengths and weaknesses of the full team and provide better targeted training for staff. All of this could streamline further training by eliminating retraining on subjects that the researchers have already collectively mastered.

“There are many ways that industry standards can help us improve the efficiency, confidence and outcomes of clinical research. The skill and competency of all professionals involved in the complex process of new medicine development is key to our success,” said Andy Lee, senior vice president of clinical operations, Merck & Co.

NBME anticipates that recognition of a universal standard of research knowledge will help lead to fewer delays, lower drug development costs and less risk for participants in clinical trials.

“While staying true to our mission,” said Dr. Katsufrakis, “the NBME is evolving to reflect the changing face of healthcare. This is our first step toward standardization in the clinical research industry.”

About The National Board of Medical Examiners
The not-for-profit National Board of Medical Examiners (NBME) is the leading assessor of health professionals in the world. Established in 1915, the NBME is an independent, objective organization that evaluates physicians, physical therapists, medical assistants, veterinarians and clinical research professionals through customized, state-of-the-art exams. The NBME develops the three-step United States Medical Licensing Examination (USMLE®), which provides a common evaluation system and established minimum standards for all doctors of medicine seeking an initial license to practice medicine in the United States. USMLE is a joint program of the NBME and the Federation of State Medical Boards. In addition, the NBME assesses physicians for board certification in various specialties. In 2016, the NBME introduced a new assessment, the Certification of Excellence in Clinical Research.

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Michelle Vroom
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