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To the Editor: Dr Tunis and colleagues¹ discussed the need for practical clinical trials (PCTs) to better meet the information needs of clinical and health policy decision makers. While there is a growing need for rigorous effectiveness studies, we doubt that such studies alone will be sufficient. First, the conduct of PCTs will not ensure that evidence is translated into clinical practice. The poor translation of evidence into practice is illustrated by numerous examples of suboptimal quality of care despite high-quality evidence.² Second, despite the presence of rigorous economic studies, efficiency and cost-effectiveness are infrequently incorporated into clinical practice guidelines.³ Third, clinical practice guidelines require significant effort for implementation, yet few health care settings have the necessary infrastructure. Rigorous effectiveness trials will be of little benefit until these issues are addressed.

Because manufacturers are among the largest supporters of clinical trials, there must be appropriate incentives for commercial entities to . . . [Full Text of this Article]

Joshua J. Ofman, MD, MSHS; Deborah P. Lubeck, PhD
US Medical Affairs
Amgen Inc
Thousand Oaks, Calif

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