Patient Involvement in the Development, Regulation, and Safe Use of Medicines

Peter J Pitts
Secretary-General of Council for International Organizations of Medical Sciences (CIOMS) located in Geneva, Switzerland
Lembit Rägo
President of the Center for Medicine in the Public Interest and a Visiting Professor at the University of Paris Medical School. Former FDA Associate Commissioner and member of the United States Senior Executive Service

Abstract:

There has been a steady advance in the application of science and technology to the diagnosis, treatment, and prevention of disease. However, in recent years there has also been a related breakthrough that can further boost the success of new medical technology. That breakthrough has been the increasing recognition and recruitment of the unique expertise and perspective of people who live with a serious or long-term disease and of those who care for these patients. A new publication by the Council for International Organizations of Medical Sciences (CIOMS), Patient involvement in the development, regulation, and safe use of medicines is a pragmatic handbook: a “how to” of sorts, for involving patients in the development, regulation, and safe use of medicines. Wherever possible, this report recommends “best practice.” What does that mean? Best practices are those which have been distilled to date from the published literature and the combined experience and expertise of members of the CIOMS Working Group XI, a diverse collective of patients, patient advocates, regulators, academics, and industry representatives. These best practice recommendations can serve as a guide only – it is not expected that the best practices set out in this report will, or should, necessarily be adopted in their entirety. Our report reflects the perspectives of its contributors variously working in academia, the pharmaceutical industry, patient advocacy community and medicines regulatory agencies. It will be useful to a wide range of readers with an interest in broadening and improving integration of patients’ perspectives. The contributors represent worldwide perspectives. giving insights from the European Union (EU), Japan and the United States of America as well as other regions. We hope that our report will prompt readers to review and select those which fit with their current organizational needs.