ing on advances in basic research and the population health problems they are intended to address. Potential new treatments must be tested in humans in order to find out whether they “work” and whether they cause harm (see Appendix B for an overview of the clinical trials process set forth in the workshop summary from an earlier Institute of Medicine [IOM] workshop in this workshop series). Clinical trials can comprise a series of rather elaborate steps, and the rationale for these trials may not be well understood by the public. An adequate infrastructure to support the efficient and effective conduct of the nation’s clinical trials enterprise can help ensure that the system does not become too narrow a bottleneck, impeding the flow of discovery from science to practice.
Meanwhile, biomedical research is advancing rapidly, and certain significant problems in clinical trials have hindered their ability to keep pace with demands to translate discoveries into improved patient care. In short, as discussed at a 2009 workshop of the IOM’s Forum in Drug Discovery, Development, and Translation, there is concern that “the current clinical trials enterprise in the United States is unable to produce the high-quality, timely, and actionable evidence needed to support a learning health care system” (IOM, 2010a). Among the broad categories of problems identified at that workshop were:
1. the length of time and high financial cost of clinical trials;
2. delays resulting from the many regulatory requirements for studies that involve human subjects;
3. the generally fragmented way clinical trials are prioritized and undertaken;
4. obstacles encountered within academic health centers;
5. lack of involvement of community physicians and their needs in the development and conduct of clinical trials; and
6. dwindling incentives for and attractions of a career as a clinical trial investigator.
A final significant problem cited at the 2009 workshop became the focus of this workshop: the increasing difficulty of recruiting and retaining an appropriate human subject population for specific clinical trials. As discussed at that meeting and in subsequent discussions of the IOM Forum, many clinical trials never recruit the number of people needed, and others accrue patients far too slowly, and the scale of need is substantial. In the United States in 2009, there were almost 11,000 clinical trials testing various medical interventions, mostly (59 percent) new drugs. Collectively, it was hoped these trials would enroll some 2.8 million people (IOM, 2010a).
In this workshop, titled “Public Engagement and Clinical Trials: New Models and Disruptive Technologies,” the issue of participation in trials