Considering Usual Medical Care in Clinical Trial Design: Scientific and Ethical Issues

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Meeting Description

The goal of this meeting is to discuss scientific and ethical principles pertaining to the use of “usual care” comparison arms in clinical trials. In particular, the meeting will address situations in which it is unclear whether a usual care comparison arm should be used at all, as well as cases where there is a lack of consensus about exactly what interventions should be provided to a usual care comparison group. Participants will discuss a series of case studies derived from actual clinical trials. Panelists and audience members will work toward development of a “Points to Consider” guidance document for the research community on ethical and scientific issues in considering usual medical care in the design of comparison arms in clinical trials. This meeting is sponsored by the NIH Program on Clinical Research Policy Analysis and Coordination (CRpac), a part of the NIH Roadmap Initiative.

Background

The practice of evidence-based medicine depends on rigorous evaluation of medical interventions through clinical trials. In many cases, trials seek to compare different interventions to the standard or usual care currently provided to patients. However, determining what constitutes usual care or determining how tightly controlled this comparison arm should be is often a challenge. Important scientific issues may arise about variability in comparison groups or lack of consensus about appropriate care in the usual care setting. Additional complexity arises when individual patient and physician preferences for specific treatments are part of the comparison group design. Ethical concerns also emerge regarding the type of medical care that provides the most benefit to a comparison group and whether it is permissible to provide less than optimal medical care for scientific reasons.

Topics

Ethical Issues in Considering Usual Medical Care in Active Control Trials
Variation in Medical Practice and Implications for Design of Comparison Groups in Clinical Trials
Design Considerations in Active Control Trials With a Focus on Usual Care
Development of a Points to Consider Guidance Document: Ethical and Scientific Principles To Guide Considerations of Usual Medical Care in Clinical Trial Design

Target Audience

Clinical researchers, statisticians, IRB members, officials of research and regulatory agencies, industry representatives, and members of professional medical organizations

For more information on program content, contact Liza Dawson, Ph.D., Contractor, NIH Program on Clinical Research Policy Analysis and Coordination, by phone at 301-451-9705 or by e-mail at dawsonl@mail.nih.gov. For information regarding registration and conference logistics, please contact Abbe Smith, Capital Consulting Corporation, by phone at 301-468-6004, ext. 402, or by e-mail at asmith@md.capconcorp.com.