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

Boardman, Helen F.; Millson, David; Phelan, Mike

doi:10.2165/00124363-200002000-00020

Cited by 7 publications

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“…There was a total of 364 statements of knowledge and skills at the start of the Delphi process, and these were gathered to form the six curricular domains with a level of achievement given for each constituent competency. The outcomes of each Delphi exercise on the six modules were analyzed at the University of Keele and published (Commentary, 1999;Millson et al, 1999;Phelan et al, 1999;Boardman et al, 2000).…”

Section: Toward the Development Of Certification Through A Competencymentioning

confidence: 99%

Evolution of the Development of Core Competencies in Pharmaceutical Medicine and Their Potential Use in Education and Training

et al. 2020

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The evolution of postgraduate vocational education and training in pharmaceutical medicine is described alongside the growth of this scientific-medical discipline and profession for the development of new medicines. Over the past 50 years, whilst the training of competent professionals for their work has been paramount, this has paralleled the need to engage with the rapid and complex changes in R&D technologies, patient and healthcare system needs, and the ethical and regulatory obligations applied to the development of medicines throughout their lifecycle. The move from unstructured training to formal programs with syllabus, curricula and assessments for certification, has been accompanied by educational changes to outcomes-based, learner-centered, competency-based programs. The evolution of education and training along with the development of the set of 57 core competencies for professional practitioners in pharmaceutical medicine are described within the competence framework of seven domains: discovery of medicines and early development; clinical development and clinical trials; medicines regulation; drug safety and surveillance; ethics and subject protection; healthcare marketplace; communication and management. The application of the core competencies in a harmonized, international platform of education and training in medicines development at the undergraduate, postgraduate and continuing professional development levels would invigorate the potential for having a competent workforce with the intent to provide faster access to better and appropriate medicines for patients worldwide.

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Section: Toward the Development Of Certification Through A Competencymentioning

confidence: 99%

Evolution of the Development of Core Competencies in Pharmaceutical Medicine and Their Potential Use in Education and Training

et al. 2020

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Outcomes from the Delphi exercise on training modules

Smith¹

2000

International Journal of Pharmaceutical Medicine

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Since last October, we have published three papers describing the outcomes of the Delphi exercise to decide the content of the curriculum for each of five advanced training modules in pharmaceutical medicine [1][2][3]. The final paper [4] dealing with the sixth module and with course delivery and assessment appears in this issue (see page 105). At the outset, we explained the Delphi exercise [5], and now we can judge what it achieved.A panel of correspondents for each module was drawn from Fellows, Members and Associates of the Faculty and others. The six panels were more or less the same size (range 27-35) and the number who replied, some after several reminders, was acceptable after phase 1 (range 16-27) but less so after phase 2 (range 10-21). The panel for healthcare marketplace was the most responsive and the one for clinical development least so.Each panel was asked, in phase 1, to accept or reject a number of knowledge and skill statements and, if they so wished, to suggest other statements. A small percentage was proposed. In phase 2, panellists were requested to put each remaining statement into one of five categories; definitely necessary, important, worth considering, not important or definitely unnecessary. Weightings factors (10, 8, 6, 4 and 2) were applied, corresponding to the rank order of the five statements. The average weightings from all panellists was calculated. As a result, a large number of statements (n = 571) fell outside the top two categories. The number of statements accepted at the conclusion of the two phases (n = 364) was just over one third. Over the six modules, the range (29-87) for the number of accepted statements was broad. Clinical pharmacology had the highest number and medicines regulation the lowest. The percentage loss of statements over phases 1 and 2 was greatest for statistics and data management (77%) and lowest for clinical development (45%).These figures may appear worse than they really are, because the statements were each presented at three levels of competency: being able to perform the task alone and unaided, doing so as part of a team, or simply having an understanding of the principles. Even so, the Delphi exercise did demonstrate differences in how the iterative process worked for one module compared with another.The draft guidelines, issued in 1997 by the Faculty, provided a skeleton curriculum for each module [6]. For three modules (clinical pharmacology, drug safety surveillance, statistics and data management) there were simply six or seven headings, and for the other three each heading was expanded by several short statements. The Delphi exercise has provided a varying number of competency statements for each module: healthcare marketplace (83), clinical pharmacology (87), medicines regulation (29), drug safety surveillance (61), statistics and data management (39) and clinical development (65). Thus, 364 statements are now assembled, but there is slight duplication from one module to another, and in a few instances the competency is one that should be...

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Outcomes from the Delphi exercise on training modules

Smith¹

2000

International Journal of Pharmaceutical Medicine

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

Cited by 7 publications

References 1 publication

Evolution of the Development of Core Competencies in Pharmaceutical Medicine and Their Potential Use in Education and Training

Evolution of the Development of Core Competencies in Pharmaceutical Medicine and Their Potential Use in Education and Training

Outcomes from the Delphi exercise on training modules

Outcomes from the Delphi exercise on training modules

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