薬理と治療

Abstract

Objectives　In pharmaceutical industry, the medical affairs（MA）department engage in the activities for creation of evidence, which consist of various designs. Thus, traditional knowledge and skills are insufficient for evidence creation in MA department. This survey was aimed to clarify key skills for evidence creation and to evaluate factors to contribute medical care through valid clinical evidence. Methods　We sent questionnaires to 70 pharmaceutical companies subscribing to the Japan Pharmaceutical Manufacturers’ Association, and collected anonymously. Result　The responses were obtained from 34 companies（48.6％）. All 34 companies set up MA department, and conducted evidence creation in MA department. The average number of research areas was 4.5 areas. The most important skills for evidence creation was the highly ethical mind. The design of clinical studies, biostatistics and knowledge of public health were also considered as important skills for evidence creation. Needs for epidemiology and biostatistics in public health were great, and need for the 10 competency regions in public health was consistently high. Needs for 10 competency regions in public health and internationality were significantly related to the number of research areas. Conclusions　In this survey, all company set up MA department, and engaged in evidence creation. The various skills including the highly ethical mind and the design of clinical studies were needed for evidence creation. In terms of public health, epidemiology, biostatistics and competency were regarded as key skills for evidence creation.