A Modified Delphi Study to Establish Essential Clinical Pharmacology Competencies.
Bernadette Johnson-Williams1,2, Kellie Reynolds3, Joga Gobburu4
1Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA. Bernadette.johnson-williams@fda.hhs.gov.
Therapeutic Innovation & Regulatory Science
|February 6, 2024
Summary
This study identified essential core and technical competencies for clinical pharmacologists in regulatory roles. The Delphi technique effectively determined key skills needed to support the evolving drug development workforce.
Area of Science:
- Clinical Pharmacology
- Drug Development
- Regulatory Science
Background:
- Competency-based education is vital for healthcare workforce development.
- Clinical pharmacology is crucial for drug development, impacting healthcare and public health.
- An adequately skilled clinical pharmacology workforce is essential for emerging drug development trends.
Purpose of the Study:
- To identify the most significant competencies for clinical pharmacologists within the regulatory environment.
- To establish a consensus on essential skills for the clinical pharmacology workforce.
Main Methods:
- A two-round modified Delphi technique involving 29 clinical pharmacologists from the Office of Clinical Pharmacology (OCP).
- Electronic questionnaires using SurveyMonkey® with Likert scale rankings to assess core and technical competencies.
- Consensus defined as 60% agreement, with data analyzed using descriptive statistics and McNemar change test.
Main Results:
- In round one, all 56 core and technical competencies were ranked as essential with at least 60% consensus.
- In round two, 62 competencies were ranked as essential with at least 60% consensus.
- The McNemar change test confirmed stability in competency rankings between the two rounds.
Conclusions:
- Essential core and technical competencies can inform educational programs for the clinical pharmacology workforce.
- The Delphi technique is effective for determining essential competencies by fostering expert consensus.
- This study provides a foundation for sustaining the clinical pharmacology workforce in regulatory settings.
Keywords:
Clinical pharmacologyCompetenciesDelphi studyDrug developmentRegulatory scienceWorkforce developmentMore Related Videos
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