Clinical Research Education and Training for Biopharmaceutical Staff

Author(s):  
Peter Marks ◽  
Sheila Gwizdak
2017 ◽  
Vol 1 (1) ◽  
pp. 3-4
Author(s):  
Paul R. Marantz ◽  
Harry P. Selker ◽  
Emma A. Meagher

AbstractThe National Board of Medical Examiners (NBME) has instituted a new multiple choice examination in order to “certify” clinical and translational investigators. As experienced research educators, we argue that this certification process is unnecessary, values knowledge over competency, may be counter-productive, and is unlikely to achieve any worthwhile outcome. We lay out these arguments in the hope of stimulating a robust discussion among leaders, faculty, and learners engaged in clinical research education and training.


Author(s):  
Sylvie Lardon ◽  
Anna-Camilla Moonen ◽  
Elisa Marraccini ◽  
Marta Debolini ◽  
Mariassunta Galli ◽  
...  

Author(s):  
Argentina Ornelas

Biomedical Research Training falls under the umbrella of Graduate Education at higher education institutions. The extent that advisory committees play in such training is not well documented, as these change from institution to institution. The National Institutes of Health (NIH), the guiding federal agency that provides the bulk of financial support to biomedical research institutions, provides input in training and workforce development based on the research of their internal advisory committees. Discussed is the background of advisory committees in guiding graduate education and the roles of advisory committees in biomedical research education and training. Discussed are the roles of advisory committees at various levels of biomedical research education and training, from funding agencies (NIH), to advisory committees guiding training programs and delivering trainee advice at individual institutions. Discussion of the challenges in establishing advisory committees to develop a productive biomedical research workforce will ensue, as we shift from educational training to workforce development.


2017 ◽  
Vol 1 (S1) ◽  
pp. 43-44
Author(s):  
Carlton Hornung ◽  
Carolyn Thomas Jones ◽  
Terri Hinkley ◽  
Vicki Ellingrod ◽  
Nancy Calvin-Naylor

OBJECTIVES/SPECIFIC AIMS: Clinical research in the 21st century will require a well-trained workforce to insure that research protocols yield valid and reliable results. Several organizations have developed lists of core competencies for clinical trial coordinators, administrators, monitors, data management/informaticians, regulatory affairs personnel, and others. While the Clinical Research Appraisal Inventory assesses the self-confidence of physician scientists to be clinical investigators, no such index exists to assess the competence of clinical research professionals who coordinate, monitor, and administer clinical trials. We developed the Competency Index for Clinical Research Professionals (CICRP) as a general index of competency (ie, GCPs) as well as sub-scales to assess competency in the specific domains of Medicines Development; Ethics and Participant Safety; Data Management; and Research Methods. METHODS/STUDY POPULATION: We analyzed data collected by the Joint Task Force on the Harmonization of Core Competencies from a survey of research professionals working in the United States and Canada. Respondents reported how competent they believed themselves to be on 51 clinical research core competencies. Factor analyzes identified 20 core competencies that defined a Competency Index for Clinical Research Professionals—General (CICRP-General, ie, GCPs) and 4 subindices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts. RESULTS/ANTICIPATED RESULTS: Factor analysis identified 20 core competencies that defined a Competency Index for Clinical Research Professionals—General (CICRP-General, ie, GCPs) and 4 subindices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts. DISCUSSION/SIGNIFICANCE OF IMPACT: These indices can be used to gage an individual’s readiness to perform general as well as more advanced research functions; to assess the education and training needs of research workers; and to evaluate the impact of education and training programs on the competency of research coordinators, monitors, and other clinical research team members.


2018 ◽  
Vol 3 (1) ◽  
pp. 537-552
Author(s):  
Rose Nicot ◽  
Stéphane Bellon ◽  
Allison Loconto ◽  
Guillaume Ollivier

Abstract In Europe, agroecology has become the center of many debates that animate political and professional arenas, particularly regarding the definition and scope of the concept itself. This paper attempts to understand the ways that the term agroecology is conceptualized by different participantsparticipants and how these concepts circulate so as to explore the interests at stake in the institutionalization of agroecology within the research and education institutions of Europe. We address the core research question of: what dynamics emerge in the networks of European stakeholders of agroecology? By combining different approaches of institutionalization based on network and discourse analysis, we study the dynamics of research, education and training organizations. We identify 10 different concepts of agroecology, distributed among 103 organizations. The significant difference that has been observed between the agroecological concepts in research and those in education/training emphasizes the gap between these two disciplines. The latter support a more political, transdisciplinary and holistic view of agroecology when compared to the former. Moreover, collaboration among European agroecology stakeholders is limited in both research and education/training. We also found that in most cases, collaboration between scholars does not guarantee a shared notion of agroecology, and conversely, sharing the same notion of agroecology does not assure collaboration. This led us to question the feasibility of institutionalizing agroecology and the missing link between a shared vision and the collective mobilization of stakeholders around a strong agroecology programme.


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