Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing An Agenda for 2020

Excerpt

Recognition is growing that the clinical trials enterprise (CTE) in the United States faces substantial challenges impeding the efficient and effective conduct of clinical research to support the development of new medicines and evaluate existing therapies. A gap has been identified between the desired state where medical care in the United States is provided solely based on high-quality evidence—and the reality—where we have limited ability to generate timely and practical evidence. There have increasingly been calls for transformation of the CTE in the United States to support the efficient development of breakthrough medicines and interventions and the evidence needed for health care decision making. Leaders in research and health care convened to discuss this visionary quest at a 2-day workshop held in November 2011 by the Institute of Medicine (IOM) Forum on Drug Discovery, Development, and Translation.

The workshop focused primarily on one type of clinical investigation, randomized controlled trials (RCTs)