Clinical Research Training Programs Must be Brought into 21st Century

Clinical trial training programs require a significant overhaul to keep pace with the growing demands of the job, say several members of the Joint Task Force for Clinical Trial Competency (JTF).

“Clinical research has become a profession,” says Stephen Sonstein, PhD, Director of Clinical Research Administration at Eastern Michigan University. “It’s no longer just a task,” he adds. Sonstein is lead author on a paper outlining JTF industry survey results scheduled to be published in the December issue of Clinical Researcher.

Given the increased size, complexity, and demands of trials, “the generally accepted on-the-job training model is not acceptable anymore,” Sonstein says. Bottom-line: Clinical Research Coordinator’s (CRCs) and others in the trial chain must be trained to get a better understanding of their roles in the development of medicines and medical devices.

The limits of current training and competency programs are crystal clear, in part because “so many CRCs don’t have a general grasp of how medicines are developed” or the broader role of study coordinators in the process, says Carolynn Jones, Assistant Professor of clinical nursing at The Ohio State University’s Masters of Applied Clinical and Preclinical Research and an active member of the task force.

Example: While the vast majority of CRCs in today’s workforce are strong in their niche area (e.g., data management, patient recruitment), they often have not gotten adequate training to have at least a cursory understanding of scientific concepts and how protocols are designed, Sonstein says.  This has a potential impact on the collection of endpoints and study outcomes, Jones points out.

In the past, competency-based education and training generally focused on specific roles (e.g., investigator, pharmaceutical physician, or clinical research nurse). The JTF aligned and harmonized competency requirements, as identified by surveys and other industry input, into a single framework of eight domains and 51 associated core competencies. These are designed to define professional competence throughout the clinical research roles, as represented by the JTF Core Competency Framework (CCF).

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Core Competency Framework Domains

The JTF CCF’s eight domains are:

  • Scientific Concepts and Research Design
  • Ethical and Participant Safety Considerations
  • Medicines Development and Regulation
  • Clinical Trial Operations (Good Clinical Practices)
  • Study and Site Management
  • Data Management and Informatics
  • Leadership and Professionalism
  • Communication and Teamwork

One organization that has already adopted the CCF is the Consortium of Academic Programs in Clinical Research (CoAPCR) by using the CCF as the curriculum foundation for their academic programs. The JTF members hope to help others recognize the need for prior academic education followed by continuing specialized training Jones says.

Editor’s Note: This is the first blog in a series examining new training concepts proposed by the Joint Task Force for Clinical Trial Competency based on its core competencies.

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