Clinical Project Management

Présentation
Pédagogie
Organisation
Formations concernées

Objectifs

Introduction aux rôle, compétences et responsabilités du chef de projet clinique

Contenu

Part I: Clinical project manager – The basics
Part II : Clinical project manager – Hard skills
Part III: Clinical project manager - Soft skills

Exercices

Méthodes d'enseignement

Leçons ex cathedra et courtes présentation préparées par les étudiants, analyse d’articles scientifiques.

Méthode d'évaluation

Participation au cours, présentation et discussion d'un manuscrit revu par des pairs, travail à domicile (~ 3 pages de réflexion sur un thème discuté pendant les cours)

Les modalités exactes de l’évaluation sont susceptibles d’être modifiées lors de l’élaboration des horaires d’examens, en fonction des contraintes pratiques auxquelles l’administration facultaire peut être confrontée, ou en cas de maladie/cas de force majeure/empiètement avec un stage, ou encore à cause de la situation sanitaire liée au coronavirus.

Sources, références et supports éventuels

DiMasi JA, Grabowski HG, Hansen RA. Innovation in the pharmaceutical industry: new estimates of R&D costs. Journal of Health Economics 2016;47:20-33.
http://phrma-docs.phrma.org/sites/default/files/pdf/2014_PhRMA_PROFILE.pdf
Thomas Moore, Hanzhe Zhang, Gerard Anderson and Caleb Alexander: “Estimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US Food and Drug Administration, 2015-2016“, JAMA Internal Medicine Sept. 24, 2018
https://theconferenceforum.org/patients-as-partners/modernizing-clinical-trials-with-iqvias-dr-cynthia-verst-2/
A. Roy (2012) Stifling New Cures: The True Cost of Lengthy Clinical Drug Trials
https://learning.pfmd.org/content/course/182/lesson/238/content/1249
https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/ich-global-meeting-ich-e8r1-guideline-general-considerations-clinical-trials-10312019-10312019
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm487077.htm
Gooszen HG. The PROPATRIA trial: best practices at the time were followed. The Lancet, Volume 375, Issue 9722, Pages 1249 - 1250, 10 April 2010
Gill RD. Statistics, ethics, and probiotica. Statistica Neerlandica, Vol 63, 1, P 1-12 (2009).
https://www.hra.nhs.uk/planning-and-improving-research/best-practice/costing-templates/
https://clinicaltrialpodcast.com/ultimate-guide-to-clinical-trial-costs/
HBR's 10 Must Reads on Managing People (with featured article "Leadership That Gets Results," by Daniel Goleman)
Managing Projects (20-Minute Manager Series)
Kelly, D., Spreafico, A. & Siu, L.L. Increasing operational and scientific efficiency in clinical trials. Br J Cancer (2020)
https://www.nature.com/articles/s41416-020-0990-8.pdf
Sessler, D., and Myles, P. Novel Clinical Trial Designs to Improve the Efficiency of Research. Anesthesiology 2020; 132:69–81
https://pubs.asahq.org/anesthesiology/article/132/1/69/108837/Novel-Clinical-Trial-Designs-to-Improve-the
Janet Woodcock, M.D., and Lisa M. LaVange, Ph.D, Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both, N Engl J Med 2017; 377:62-70
https://www.nejm.org/doi/full/10.1056/NEJMra1510062
https://www.washingtonpost.com/business/economy/pfizer-had-clues-its-blockbuster-drug-could-prevent-alzheimers-why-didnt-it-tell-the-world/2019/06/04/9092e08a-7a61-11e9-8bb7-0fc796cf2ec0_story.html?noredirect=on&utm_term=.30a505569971
Ross J et al. (2012). Promoting transparency in pharmaceutical industry. American Journal of Public Health, vol 102, n1, 72-80
Devin S. McCaskell et al, Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial, Trials (2019) 20:532 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6712681/pdf/13063_2019_Article_3634.pdf
Arundel A & Gellatly J. Learning from OCTET – exploring the acceptability of clinical trials management methods, Trials. 2018; 19: 378 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6045834/
Farrell, B., Kenyon, S. & Shakur, H. Managing clinical trials. Trials 11, 78 (2010). https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-11-78
Pearce et al. (2015) Randomised trials in context: practical problems and social aspects of evidence-based medicine and policy. Trials, 16:394
Foster et al. (2015). Barriers and facilitators to patient recruitment to a cluster randomized controlled trial in primary care: lessons for future trials. BMC Medical Research Methodology 15:18.
Bleidorn et al. (2015). Why do – or don’t – patients with urinary tract infection participate in a clinical trial? A qualitative study in German family medicine. German Medical Science, 13.
Samyuktha Ajay and Arun Bhatt (2010). Training needs of clinical research associates, Perspect Clin Res. 2010 Oct-Dec; 1(4): 134–138.
Wright, J et al, (2002). Factors that influence the recruitment of patients to Phase III studies in oncology, Cancer 2002;95:1584 –91.
Kurt A et al (2017) Factors Influencing Participation in Clinical Trials: Emergency Medicine vs. Other Specialties, West J Emerg Med. 2017 Aug;18(5):846-855

Langue d'instruction

Français

Formation	Programme d’études	Bloc	Crédits	Obligatoire
Master 120 en sciences biomédicales à finalité spécialisée en recherche clinique	Standard	0	2
Master 120 en sciences biomédicales à finalité spécialisée en recherche clinique	Standard	2	2