CLINICAL PROJECT MANAGEMENT

Delbeque Laure (12 h - 2 ECTS)

Laure Delbecque holds a PhD in psychological sciences, as well as a Master’s degree in neuropsychology and cognitive psychology awarded by the Université Libre de Bruxelles, Belgium. She is currently Research Scientist at Eli Lilly in the Patient-Focused Outcomes center of expertise. Before joining Lilly, Laure held positions as expert in patient-reorted outcomes (PRO), (e)PRO researcher, Data Management Specialist, and Publication Manager in major consultancy companies. She was also a teaching assistant for statistics applied to human sciences at the Université Libre de Bruxelles and is currently visiting professor at the University of Namur, Belgium, for the Clinical Project Management and Introduction to PRO courses.

Theory: 12 h

Title	Clinical Project Management (2 ECTS)
Program	Part I: Clinical project manager – Hard skills Part II: Clinical project manager – Soft skills Part III: How to optimize clinical trials?
Sources	• Ross J et al. (2012). Promoting transparency in pharmaceutical industry. American Journal of Public Health, vol 102, n1, 72-80. • 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. • Devidas Menon & Tania Stafinski (2011) Role of patient and public participation in health technology assessment and coverage decisions, Expert Review of Pharmacoeconomics & Outcomes Research, 11:1, 75-89. • Samyukta and Bhatt (2010): training needs of clinical research associates. Perspect Clin Res 2010; 1:134-138. • Wright et al (2002). Factors that influence the recruitment of patients to Phase III studies in oncology. Cancer 2002;95:1584-91. • Kurt et al (2017). Factors influencing participation in clinical trials: Emergency Medicine vs Other specialities, West J Emerg Med 1017;18:846-855.
Objectives and expected results	Introduction to the role, skills and responsibilities of a Clinical Project Manager.
Prerequisites	Clinical Trials.
Teaching methods	Ex Cathedra.
Exam modality	Course participation, presentation and discussion of a peer-reviewed manuscript, home work (~ 3 pages reflection about a theme discussed during the courses).

TITLE

Clinical Project Management (2 ECTS)

PROGRAM

Part I: Clinical project manager – Hard skills

Part II: Clinical project manager – Soft skills

Part III: How to optimize clinical trials?

SOURCES

Ross J et al. (2012). Promoting transparency in pharmaceutical industry. American Journal of Public Health, vol 102, n1, 72-80.
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.
Devidas Menon & Tania Stafinski (2011) Role of patient and public participation in health technology assessment and coverage decisions, Expert Review of Pharmacoeconomics & Outcomes Research, 11:1, 75-89.
Samyukta and Bhatt (2010): training needs of clinical research associates. Perspect Clin Res 2010; 1:134-138.
Wright et al (2002). Factors that influence the recruitment of patients to Phase III studies in oncology. Cancer 2002;95:1584-91.
Kurt et al (2017). Factors influencing participation in clinical trials: Emergency Medicine vs Other specialities, West J Emerg Med 1017;18:846-855.

OBJECTIVES AND EXPECTED RESULTS

Introduction to the role, skills and responsibilities of a Clinical Project Manager.

PREREQUISITES

Clinical Trials.

TEACHING METHODS

Ex Cathedra.

EXAM MODALITY

Course participation, presentation and discussion of a peer-reviewed manuscript, home work (~ 3 pages reflection about a theme discussed during the courses).

Last modified: April 29, 2021