Patient involvement in the development, regulation and safe use of medicines

Abstract

This report from the Council for International Organizations of Medical Sciences (CIOMS) describes the importance of systematically involving patients throughout a medicine’s life – from its early development, through regulatory process to ongoing monitoring and safe use in everyday healthcare. It provides a comprehensive overview of the current knowledge about the benefits of patient involvement and existing initiatives, gives many examples and recommendations, and addresses the remaining challenges and practice gaps. The report will prompt readers to implement its best practice recommendations according to how well they fit in with their organisational and national needs. The report combines the experience and expertise of the CIOMS Working Group XI on Patient involvement in the development, regulation and safe use of medicines. It also incorporates views gathered from an open meeting in Switzerland and a workshop in Uganda, which both brought together members of the public, patient organisation representatives, regulators, drug development experts, industry, academia, health professionals and other related stakeholders. The report was finalised following a public consultation.