This is an unprecedented time for clinical research. The number and complexity of clinical research studies have increased significantly in the last decade. Individual participation in clinical research broadened, with an increase in diverse populations, diseases, and geographic settings. The successful execution of these studies, however, has been compromised by an international shortage of clinical research professionals, coupled with an appreciation of the growing number of core competencies necessary for performance. Developed over a decade ago, the Joint Task Force for Clinical Trial Competency (JTF) Framework outlines the knowledge, skills and attitudes that are essential for the safe and effective conduct of a clinical study. This framework has been used to develop professional pathways, trainings, and certification programs and has been extended internationally through translation. However, the clinical research paradigm is changing: novel study designs including adaptive, platform, pragmatic, and embedded trials are emerging; research “sites” have expanded to include local pharmacies, laboratories, telehealth and remote data collection; digital technologies have transformed data sources and outcome assessments; and attention to inclusion of underrepresented and underserved populations is now paramount. The pace of change demands innovative solutions for the future, setting the stage for new best practices. Authors are encouraged to address the challenges, opportunities, novel approaches and progress toward closing the gaps and improving clinical research professional development across the workforce spectrum. This Research Topic aims to collect articles on the following topics:- Clinical research roles and professionalism- Clinical research academic education, training and competency development, assessment- Clinical research professional employment, retention, progression - Diversity of the clinical research workforce- Applications and contributions of the JTF Framework- Clinical research workforce development in the setting of the evolving clinical research paradigm - Clinical research team science, defining research teams, workforce spectrumDr. Bierer is employed by Brigham and Women’s Hospital and appointed at Harvard Medical School. She is chair of the Board of Trustees of the Edward P Evans Foundation, serves on the Board of Directors of Clinithink, and is or has been a consultant on ethical issues to Eli Lilly and Merck.Topic coordinator Emma Akuffo provides consultancy services to Richmond Pharmacology.
This is an unprecedented time for clinical research. The number and complexity of clinical research studies have increased significantly in the last decade. Individual participation in clinical research broadened, with an increase in diverse populations, diseases, and geographic settings. The successful execution of these studies, however, has been compromised by an international shortage of clinical research professionals, coupled with an appreciation of the growing number of core competencies necessary for performance. Developed over a decade ago, the Joint Task Force for Clinical Trial Competency (JTF) Framework outlines the knowledge, skills and attitudes that are essential for the safe and effective conduct of a clinical study. This framework has been used to develop professional pathways, trainings, and certification programs and has been extended internationally through translation. However, the clinical research paradigm is changing: novel study designs including adaptive, platform, pragmatic, and embedded trials are emerging; research “sites” have expanded to include local pharmacies, laboratories, telehealth and remote data collection; digital technologies have transformed data sources and outcome assessments; and attention to inclusion of underrepresented and underserved populations is now paramount. The pace of change demands innovative solutions for the future, setting the stage for new best practices. Authors are encouraged to address the challenges, opportunities, novel approaches and progress toward closing the gaps and improving clinical research professional development across the workforce spectrum. This Research Topic aims to collect articles on the following topics:- Clinical research roles and professionalism- Clinical research academic education, training and competency development, assessment- Clinical research professional employment, retention, progression - Diversity of the clinical research workforce- Applications and contributions of the JTF Framework- Clinical research workforce development in the setting of the evolving clinical research paradigm - Clinical research team science, defining research teams, workforce spectrumDr. Bierer is employed by Brigham and Women’s Hospital and appointed at Harvard Medical School. She is chair of the Board of Trustees of the Edward P Evans Foundation, serves on the Board of Directors of Clinithink, and is or has been a consultant on ethical issues to Eli Lilly and Merck.Topic coordinator Emma Akuffo provides consultancy services to Richmond Pharmacology.