Academic Program Accreditation: An Important Criterion for Quality in the Preparation of Tomorrow’s Clinical Research Workforce

February 07, 2020

It is widely agreed upon that there has been a significant increase in both the number and the complexity of clinical trials during the past decade.  The global clinical trial service market is predicted to reach $64B in 2020 (Centerwatch, 2017).  The demand for clinical research professionals already exceeds the supply and the pressure to grow the clinical research workforce will undoubtedly increase. The majority of the current workforce has been trained “on the job” and very few enter the clinical research profession as a direct result of academic education or knowledge of the field.   Academic institutions in the US and internationally have recognized these growing personnel needs.  Today there are over 100 academic programs that offer degrees and certificates to physician investigators, clinical research coordinators, clinical trial monitors, regulatory affairs professionals, clinical data management professionals and clinical project managers.  Clinical research has become a recognized academic discipline, and professional organizations have developed to provide a forum for clinical research educators through publication, seminars, and meetings and to provide expertise to governmental agencies that regulate the profession.  Among those organizations are the Consortium of Academic Programs in Clinical Research, the Association of Graduate Regulatory Educators, the Pharmatrain Federation, and the Global Health Network.

As the number of academic programs increased, it became necessary to define and standardize the content of these programs.  The framework of clinical research core competencies  defined by the Joint Taskforce for Clinical Trial Competency (JTF);  has been widely—and globally—accepted by the research enterprise.  In 2017, the JTF framework was adopted as the Standard for academic program curricular content by the newly formed Committee on Accreditation of Academic Programs in Clinical Research (CAAPCR).  CAAPCR is part of the Commission of Accreditation of Allied Health Education Programs (CAAHEP), the largest international accrediting agency of allied health academic programs.  The accreditation process requires that an institution produce a detailed self-study that documents that the program meets the required Standards. Representatives of CAAPCR then conduct a site visit to validate the content of the self-study and further assess the program. Thereafter, the Board of Directors of both CAAPCR and CAAHEP review and approve accreditation of the program. The first two academic institutions which have been formally accredited by CAAHEP are Arizona State University and Durham Technical Community College.  There are 5 additional academic institutions which have requested accreditation services and are in the process of completing self-studies.  As the profession of clinical research continues to mature, formal academic program accreditation is becoming an important criterion for quality in the preparation of tomorrow’s workforce.