Gestión de proyectos en investigación clínica

Contenido principal del artículo

María L. Posadas-Martínez

Resumen

El éxito de una investigación depende de los aspectos científicos y de gestión. Los proyectos de investigación tienen similitud con otros proyectos de negocio.  En este artículo se revisa la aplicación de metodología de gestión de proyectos del Project Management Institute (PMI) a un proyecto de investigación en sus fases de inicio, planificación, implementación, monitorización y cierre. Se plantean 3 desafíos en la implementación relacionados con el reclutamiento, seguimiento y gestión del dato.

Detalles del artículo

Cómo citar
1.
Posadas-Martínez ML. Gestión de proyectos en investigación clínica. Rev. Hosp. Ital. B.Aires [Internet]. 29 de diciembre de 2022 [citado 26 de abril de 2024];42(4):p. 264-266. Disponible en: //ojs.hospitalitaliano.org.ar/index.php/revistahi/article/view/241
Sección
Notas sobre estadística e investigación

Citas

Files DC, Hume PS, Krall J, et al. Grant writing for clinicians in training: an important career development exercise. Chest. 2020;157(4):932-935. https://doi.org/10.1016/j.chest.2019.10.024.

Mackway-Jones K. Seeking funding for research. Emerg Med J. 2003;20(4):359-361. https://doi.org/10.1136/emj.20.4.359.

Farrell B, Kenyon S, Shakur H. Managing clinical trials. Trials. 2010;11:78. https://doi.org/10.1186/1745-6215-11-78.

Goodarzynejad H, Babamahmoodi A. Project management of randomized clinical trials: a narrative review. Iran Red Crescent Med J. 2015;17(8):e11602. https://doi.org/10.5812/ircmj.11602.

Blümle A, Meerpohl JJ, Schumacher M, et al. Fate of clinical research studies after ethical approval--follow-up of study protocols until publication. PLoS One. 2014;9(2):e87184. https://doi.org/10.1371/journal.pone.0087184.

Campbell MK, Snowdon C, Francis D, et al. Recruitment to randomised trials: strategies for trial enrollment and participation study. The STEPS study. Health Technol Assess. 2007;11(48):iii, ix-105. https://doi.org/10.3310/hta11480.

Project Management Institute. A guide to the Project Management Body of Knowledge (Pmbok(r) Guide). 7th ed. Newtown Square, PA: Pmbok(r) Guide; 2021.

Centers for Disease Control and Prevention. Project management guide [Internet]. Atlanta, GA: CDC, [2007] [citado 2022 feb 11]. Disponible en: https://www2.cdc.gov/cdcup/library/pmg/default.htm.

Petrie KA, Carnahan RH, Brown AM, et al. Providing experiential business and management training for biomedical research trainees. CBE Life Sci Educ. 2017;16(3):ar51. https://doi.org/10.1187/cbe.17-05-0074.

Wikipedia. Project Management Institute [Internet]. Fundación Wikimedia; actualizado 2022 ago 10 [citado 2022 dic 19]. Disponible en: https://es.wikipedia.org/wiki/Project_Management_Institute.

Cao H, Shang H, Mu W, et al. Internal challenge to clinical trial project management: strategies for managing investigator compliance. J Evid Based Med. 2013;6(3):157-166. https://doi.org/10.1111/jebm.12053.

McCaskell DS, Molloy AJ, Childerhose L, et al. Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial. Trials. 2019;20(1):532. https://doi.org/10.1186/s13063-019-3634-7. Errata en: Trials. 2019;20(1):606. https://doi.org/10.1186/s13063-019-3716-6.

Arundel C, Gellatly J. Learning from OCTET - exploring the acceptability of clinical trials management methods. Trials. 2018;19(1):378. https://doi.org/10.1186/s13063-018-2765-6.

Chan YH. Randomised controlled trials (RCTs)--essentials. Singapore Med J. 2003;44(2):60-63.

Foot BJ, Sadi P. Research project management: managing clinical, health and operational research projects [video]. Singapur: Centre for Healthcare Innovation; 2019 [citado 2022 feb 11]. Disponible en: https://www.youtube.com/watch?v=oPaqxsVG8Mg.

Lazovic C. Basics - Part 23: jobs in clinical trials: clinical project manager [video]. GCP Mindset; 2021 [citado 2022 feb 11]. Disponible en: https://www.youtube.com/watch?v=tSO17j7lvj4.

Beukers MW. Project management of life-science research projects: project characteristics, challenges and training needs. Drug Discov Today. 2011;16(3-4):93-98. https://doi.org/10.1016/j.drudis.2010.11.015.

Pandi-Perumal SR, Akhter S, Zizi F, et al. Project stakeholder management in the clinical research environment: how to do it right. Front Psychiatry. 2015;6:71. https://doi.org/10.3389/fpsyt.2015.00071.

Fry A, Mortimer K, Ramsay L. Clinical research and the culture of collaboration. Aust J Adv Nurs. 1994;11(3):18-25.

Friedman LM, Furberg CD, Demets D, et al. Fundamentals of clinical trials. Cham: Springer: 2015.

Kanza S, Knight NJ. Behind every great research project is great data management. BMC Res Notes. 2022;15(1):20. https://doi.org/10.1186/s13104-022-05908-5.