Evidence map›Paper›PMID 38319585›Full record

ArticleTherapeutic innovation & regulatory science2024

A Modified Delphi Study to Establish Essential Clinical Pharmacology Competencies.

Bernadette Johnson-Williams, Kellie Reynolds, Joga Gobburu, Albert Rundio

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Article in Therapeutic innovation & regulatory science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Bernadette Johnson-WilliamsOffice 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.ORCID 0000-0002-0032-8212
Kellie ReynoldsOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Joga GobburuSchool of Pharmacy, University of Maryland, Baltimore, 620 W. Lexington Street, Baltimore, MD, 21201, USA.
Albert Rundio *College of Nursing and Health Professions, Drexel University, 60 N. 36th Street, Philadelphia, PA, 19104, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCompetency-based education has been commonly used to enhance the healthcare workforce for some time. A translational discipline that is integral to drug development and impactful on healthcare and public health is clinical pharmacology. With such contribution, it is essential that the clinical pharmacology workforce is adequately equipped to address the demands of emerging trends of drug development.

objectivesThe primary objective of this study was to determine the most significant competencies needed for a clinical pharmacologist in the regulatory environment.

methodsA two round modified Delphi technique was administered to 29 clinical pharmacologists within the Office of Clinical Pharmacology (OCP) between November 2021-January 2022. A questionnaire consisting of core and technical competencies was administered electronically using SurveyMonkey ® to gain consensus about essential clinical pharmacology competencies. Participants used a Likert scale to rank importance of competencies from strongly agree (1), agree (2), neutral (3), disagree (4), strongly disagree (5). Participants also suggested topics to be included in the next round. Consensus was set at 60%. The competencies receiving the most consensus at 60% in round one and the new topics proceeded to the second round. In the second and final round, participants ranked the suggested competencies. Descriptive statistics and a McNemar change test were utilized to analyze data. Only data from the participants who completed both rounds was used in the study.

resultsIn round one participants ranked all fifty-six core and technical competencies as essential with consensus of at least 60%. In round two, participants ranked sixty-two competencies as essential with consensus of at least 60%. A McNemar change test demonstrated stability of ranking between rounds.

conclusionEssential core and technical competencies can build education programs to sustain the emerging clinical pharmacology workforce in the Office of Clinical Pharmacology. The Delphi technique is a suitable approach to determine essential competencies because it cultivates consensus and gains insight from experts in the forefront of drug development.

Indexed as

Clinical CompetenceDelphi TechniquePharmacology, ClinicalCompetency-Based EducationConsensusDrug DevelopmentFemaleHumansMaleSurveys and QuestionnairesClinical pharmacologyCompetenciesDelphi studyDrug developmentRegulatory scienceWorkforce development

Identifiers

PMID38319585
PMCPMC11043191

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.