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Is there a need for a universal benefit–risk assessment framework for medicines? Regulatory and industry perspectives
Author(s) -
Leong James,
McAuslane Neil,
Walker Stuart,
Salek Sam
Publication year - 2013
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.3464
Subject(s) - toolbox , process management , medicine , quality (philosophy) , resource (disambiguation) , knowledge management , risk analysis (engineering) , business , management science , computer science , engineering , computer network , philosophy , epistemology , programming language
Purpose To explore the current status and need for a universal benefit–risk framework for medicines in regulatory agencies and pharmaceutical companies. Methods A questionnaire was developed and sent to 14 mature regulatory agencies and 24 major companies. The data were analysed using descriptive statistics, for a minority of questions preceded by manual grouping of the responses. Results Overall response rate was 82%, and study participants included key decision makers from agencies and companies. None used a fully quantitative system, most companies preferring a qualitative method. The major reasons for this group not using semi‐quantitative or quantitative systems were lack of a universal and scientifically validated framework. The main advantages of a benefit–risk framework were that it provided a systematic standardised approach to decision‐making and that it acted as a tool to enhance quality of communication. It was also reported that a framework should be of value to both agencies and companies throughout the life cycle of a product. They believed that it is possible to develop an overarching benefit–risk framework that should involve relevant stakeholders in the development, validation and application of a universal framework. The entire cohort indicated common barriers to implementing a framework were resource limitations, a lack of knowledge and a scientifically validated and acceptable framework. Conclusions Stakeholders prefer a semi‐quantitative, overarching framework that incorporates a toolbox of different methodologies. A coordinating committee of relevant stakeholders should be formed to guide its development and implementation. Through engaging the stakeholders, these outcomes confirm sentiments and need for developing a universal benefit–risk assessment framework. Copyright © 2013 John Wiley & Sons, Ltd.