Comparative effectiveness research (CER) aims to provide decision makers with the evidence needed to evaluate the benefits and harms of alternative clinical management strategies. CER has become a national priority, with considerable new research funding allocated. Cardiovascular disease is a priority area for CER. This workshop report provides an overview of CER methods, with an emphasis on practical clinical trials and observational treatment comparisons. The report also details recommendations to the National Heart, Lung, and Blood Institute for a new framework for evidence development to foster cardiovascular CER, and specific studies to address 8 clinical issues identified by the Institute of Medicine as high priorities for cardiovascular CER.
Bibliographical noteFunding Information:
Drs. Cook, Wells, and Lauer are full-time employees of the National Heart, Lung, and Blood Institute (NHLBI). The views expressed in this manuscript do not necessarily represent the views of the NHLBI, National Institutes of Health, or any other government entity. Dr. Goff is a research consultant for and a data and safety monitoring board member for a clinical trial of a glucose-lowering medication marketed by Merck and Takeda. Dr. Hirsch has relationships with Pozen Medical, Merck, AstraZeneca, Abbott Vascular, Viromed, Summit Doppler, Novartis, and Cytokinetics. Dr. Hylek is on the scientific advisory board of Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Johnson & Johnson, Merck, Ortho-McNeil, and Pfizer. Dr. Selby was employed by Kaiser Permanente and is currently the Executive Director of the Patient Centered Outcomes Research Institute (PCORI); the opinions expressed in this paper do not necessarily reflect those of PCORI. Dr. Udelson has received research funding from the NHLBI. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Hlatky and Douglas cochaired the workshop.
- clinical trials
- comparative effectiveness
- research methods