IOM Report Envisions 'Transformed Clinical Trials Enterprise' in US

A report released by the US Institute of Medicine (IOM) looks at the future of the US' clinical trials enterprise, and finds a growing gap between the demand and capacity for high quality evidence to support medical treatment decisions.

The report, Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020, is a summary of a November 2011 workshop conducted by the IOM's Forum on Drug Discovery, Development and Translation. Prominent among the panel's members: top US drug regulator Janet Woodcock, director of the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research.

The report primarily focuses on randomized clinical trials (RCTs), which are the main vehicle by which modern medical science assesses the risks and benefits of a product.

The report also highlights a number of issues currently present in RCT's, including:

• the need for more robust information sharing among researchers, patients, and physicians about RCT opportunities;
• the availability of experimental treatments outside of participating in an RCT
• inadequate funding mechanisms to support RCT participation
• lack of prestige allocated within the medical school setting to the conduct of clinical trials
• delays and logistical problems associated with a fragmented clinical trials infrastructure and healthcare system

Some of the solutions put forth in the IOM workshop should be familiar to most regulatory professionals: adaptive clinical trial designs, pragmatic trials exploring real-world conditions and virtual or web-based clinical trials.

The IOM paper moves beyond just these however, and addresses some of the other vestigial problems inherent in the clinical trial enterprise system, including the use of evidence in clinical settings, the use of electronic health records to boost follow-up data, new business models for clinical trials and building RCT infrastructure.

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