The European Medicines Agency (EMA) shared the CIOMS report on patient involvement in the development, regulation and safe use of medicines. It is available as free download. The report is the result of four years of work with patient group leaders, academics, industry experts, regulators and other stakeholders.
About the report
The report describes the importance of systematically involving patients throughout a medicine’s lifecycle. From early development through the regulatory process to ongoing monitoring and safe use in everyday healthcare. The report provides an overview of current knowledge about the benefits of patient involvement and existing initiatives. In addition to this, it gives examples and recommendations, and addresses the remaining challenges and practice gaps.
The aim of the report is to prompt readers to implement its best practice recommendations according to how well they fit in with their organizational and national needs.
It 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. Both convened members of the public, patient organization representatives, regulators, drug development experts, industry, academia, health professionals and other related stakeholders. The report was finalized following a public consultation.
CIOMS (Council for International Organizations of Medical Sciences) is an international, non-governmental, non-profit organization. Its mission is to advance public health through guidance on health research and policy. This is including ethics, medical product development and pharmacovigilance.