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Abstract
Capacity development for clinical research is held back by a lack of recognition for the skills acquired through involvement in clinical trials and in other varied types of global health research studies. Although some competency frameworks and associated recognised career pathways exist for different clinical research roles, they mostly apply to a single role or study setting. Our experience supports the need for an integrated approach, looking at the many roles in parallel and at all types of clinical research beyond trials. Here, we propose a single, flexible framework which is applicable to the full global health research team, and can be used for recognising staff by highlighting acquired skills and possible progression between various roles. It can also illuminate where capacity needs strengthening and contribute to raising research engagement. Through systematic analysis of existing competency frameworks and current job descriptions covering 11 distinct, broad clinical research roles, we identified and defined 50 key competencies required by the team as a whole and throughout the study life cycle. The competencies are relevant and adaptable to studies that differ in design, geographical location or disease, and fall in five main areas—(1) Ethics, Quality and Risk Management; (2) Study and Site Management; (3) Research Operations; (4) Scientific Thinking; and (5) Professional Skills. A pilot framework and implementation tools are now available online and in paper format. They have the potential to be a new mechanism for enabling research skills development and career progression for all staff engaged in clinical research globally.
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
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Footnotes
AJ and TF contributed equally.
Handling editor Seye Abimbola.
Contributors All authors contributed to designing the study. TF and AJ collected and analysed the data with particular support and comments from VE and FvL. AJ created the design of the framework and its online App. TF and AJ wrote the first draft. FvL, VE, TL, LB, MV and PL reviewed and approved the manuscript. TL is the guarantor of the work.
Funding The Special Programme for Research and Training in Tropical Diseases (TDR).
Competing interests All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/coi_disclosure.pdf and declare: financial support for the submitted work from TDR; The Global Health Network is funded by the Bill and Melinda Gates Foundation; AJ holds a Nuffield Department of Medicine (NDM, University of Oxford) Prize Studentship, jointly covered by the Medical Research Council (UK) and NDM; no other relationships or activities that could appear to have influenced the submitted work.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The study brought together existing data, mainly publically available data, which are referenced in the online reports, and from data obtained upon request and subject from a number of different sources. Full details how these data were obtained are available in the documentation available at https://globalhealthtrials.tghn.org/articles/tdr-global-competency-framework-clinical-research-set-tools-help-develop-clinical-researchers/.