Criteria for the choice and definition of volunteers and patients in drug development
The issues surrounding the selection of patients for drug trials are the subject of a recent report summarizing the outcome of 12 years of activity in the area supported under a COST scheme of cooperation. The European Commission, DG XIII, has recently published the final report on the COST Action. The report is called COST action B1: Criteria for the choice and definition of healthy volunteers and/or patients in phase I and phase II studies in drug development. The report reviews the progress and accomplishments of the Action, the specific contributions to the field of research covered, the wider implications of the work for those involved in the development and use of drugs and the possible indirect effects on regulatory agencies, funding bodies and others.