Patient involvement

Leader: National Institutes of Health (NIH)

Objectives:
To foster patient involvement as trial participants, and also in trial design, in the definition of outcome measures, in Ethics Committees, and in establishing research priorities.

Description of the work:
The role of patients in clinical trials is mostly restricted to their participation as study ‘subjects’. Although this is common practice in some countries or organisations, there are no standard requirements for patient representatives in ethics committees, or standards for involvement of patient representatives in scientific aspects of clinical research activities (protocol design, definition of relevant outcome measures, scientific prioritisation, peer review of proposals, development of trial educational materials, etc.).

In this context, this activity will aim to develop a framework for the involvement of patients in clinical research not only as trial participants but also in the design of the trial, the definition of outcome measures and in establishing research priorities. This will be supported by training activities.