Trends in Consent for Clinical Trials in Cardiovascular Disease.

• Type of Material: Article
• Authors: Louis A. Kerkhoff, Augusta University; Javed Butler, Emory University; Anita A. Kelkar, Emory University; Supriya Shore, Emory University; Candace D. Speight, Emory University; Louisa K. Wall, Emory University; Neal Dickert Jr, Emory University
• Language: English
• Date: 2016-06-17
• Publisher: American Heart Association: JAHA
• Publication Version: Final Published Version
• Copyright Statement: © 2016 The Authors.
• License: Creative Commons Attribution-NonCommercial 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1161/JAHA.116.003582
• Title of Journal or Parent Work: Journal of the American Heart Association
• ISSN: 2047-9980
• Volume: 5
• Issue: 6
• Start Page: e003582
• End Page: e003582
• Grant/Funding Information: Support for this project was provided by the Robert W. Woodruff Foundation.
• Keywords: informed consent; recruitment; trials; clinical trial; research ethics
• Research Categories: Health Sciences, Epidemiology; Health Sciences, Medicine and Surgery; Health Sciences, General

Abstract

BACKGROUND: Cardiovascular clinical trials depend on patient enrollment. Enrollment rates appear inadequate, but little is known about how frequently patients accept or decline offers of enrollment. The objective of this study was to assess trends and predictors of patient acceptance of offers to enroll in clinical trials for cardiovascular disease. METHODS AND RESULTS: We utilized an established database containing all randomized, controlled trials (n=1224) in cardiovascular disease published between 2001 and 2012 in the 8 highest-impact general medical and cardiology journals. Studies were eligible if the number of patients approached and number of patients declining enrollment could be ascertained from published materials. All studies were screened for eligibility. Each eligible study was reviewed by 3 co-authors. All discrepancies were resolved by the group. The main outcome was acceptance rate, defined as the number of patients enrolled divided by the number patients who were eligible and approached. Only 21.7% (n=266) of studies provided information sufficient to assess patient enrollment and refusals. The median acceptance rate across trials was 83.2%. Significant predictors of higher enrollment included: enrollment in the acute setting (P=0.031); geographical region (P<0.001 for group); and trial sponsorship (P=0.006 for group). CONCLUSIONS: Rates of reporting data sufficient to calculate acceptance rates are low. This compromises the ability to identify drivers of low enrollment and assess trial generalizability. However, the high rates of acceptance observed suggest that factors other than patients' decisions may be the primary drivers of declining rates of trial enrollment.