Community-based clinical trials: Innovative regulatory procedures to enhance translation.

Currently there are more and more clinical trials conducted where clinical practice takes place — a community-based medical clinic. However, most of the “real life” clinics are not usually involved in research activities and for them, most of the research-oriented procedures (especially the regulatory procedures and paperwork) could be burdensome. Health care providers are very busy in their day to day work and have little time to become familiar with all the research procedures before starting recruitment in a multi-site clinical trial. Based on their experience in conducting multi-site clinical trials involving community treatment programs, the speakers in this session addressed critical regulatory issues and provided some examples on how to manage and reduce the burden from several perspectives: sponsor, investigator, IRB reviewer and provider. The presentation ended with a look from the provider perspective, summarizing the issues and recommendations discussed and answering the question, “Why become a community treatment program research site?”