Higher medical training in pharmaceutical medicine: Delphi exercise on drug safety surveillance and statistics and data management advanced modules

Summary

A Delphi exercise were undertaken to develop the curriculum in pharmaceutical medicine necessary for each advanced training module that will lead to the award of a Certificate of Completion of Specialist Medical Training. The Delphi exercise used a panel for each module to identify the range of competencies and define the knowledge and skills required to fulfil the professional roles and responsibilities of a pharmaceutical physician.

For the drug safety surveillance module, 59% (20/34) of Delphi correspondents identified responded in the first phase and 77% (15/20) went on to complete the second phase. Statements were weighted using mean scores achieved to allow the Faculty to assess relative merits for each independent statement. The highest weighted competency statements for the drug safety surveillance module related to the history of pharmacovigilance. The lowest weighted competency statements concerned pharmacoepidemiology, and toxicology and its relationship to clinical development.

For the statistics and data management module, 65% (20/31) of Delphi correspondents identified responded in the first phase and 70% (14/20) completed the second phase. For the statistics and data management module, the highest weighted competency statements related to statistical principles. The lowest weighted competency statements concerned data review and validation, and data management.