We are pleased to share the CIOMS report on “Patient involvement in the development, regulation and safe use of medicines”, which is available as a free download.

The report is the result of four years of work with patient group leaders, academics, industry experts, regulators and other stakeholders, and the EMA.

It 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, and provides a comprehensive overview of current knowledge regarding the benefits of patient involvement and existing initiatives, with examples and recommendations. It also 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.

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 organization representatives, regulators, drug development experts, industry, academia, health professionals and other related stakeholders. The report was finalized following a public consultation.

CIOMS is an international, non-governmental, non-profit organization with the mission to advance public health through guidance on health research and policy including ethics, medical product development and pharmacovigilance.

You can download the free report here.

Disclaimers

  • The material in these reviews is from various public open access sources, meant for educational and informational purposes only
  • Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
  • No official support by any organization(s) has been provided or should be inferred