To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine’s (IOM’s) Forum on Drug Discovery, Development, and Translation (the “Drug Forum”) held a 2-day workshop on October 7–8, 2009, titled Transforming Clinical Research in the United States. This workshop laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include the following: further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.

This report builds on a body of related IOM work. Focused on the national objective of achieving the best health outcome for each patient, the IOM Roundtable on Value & Science-Driven Health Care explores the need for a learning health care system in the United States and possible ways such a system can create value in health care interactions. Reports based on the Roundtable’s recent workshops include The Healthcare Imperative: Lowering Costs and Improving Outcomes (IOM, 2009a) and Value in Health Care: Accounting for Cost, Quality, Safety, Outcomes, and Innovation (IOM, 2010). The IOM’s National Cancer Policy Forum is discussing strategies for improving cancer clinical trials and the National Cancer Institute’s (NCI’s) Cooperative Group program. That Forum’s recent reports include Multi-Center Phase III Clinical Trials and NCI Cooperative Groups (IOM, 2009b) and Improving the Quality of Cancer Clinical Trials (IOM, 2008).

THE CLINICAL TRIALS PROCESS

The focus of the workshop was clinical trials—a type of clinical research that prospectively evaluates the risks and benefits of a drug, device, behavioral intervention, or other form of treatment. The materials and resources (human capital, financial support, patient participants, and institutional commitment) available to conduct such research can vary by research sponsor, disease area being studied, and type of research question being asked. Once a research question has been posed and the concept for a study has been defined, funding must be secured to continue the process. The study protocol, which is an extensive blueprint for the trial and how it will be conducted, is also required to be submitted to the relevant institutions and organizations that provide ethical and regulatory approval.

All clinical trials are designed to answer one or more specific questions. They can vary by the study population chosen (number of subjects, as well as criteria to enter the study) and the type of question(s) posed. For



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