Trends in Consent for Clinical Trials in Cardiovascular Disease.
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.



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).



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.
Medical College of Georgia-University of Georgia Medical Partnership, Augusta University, Athens, GA.
Louis A
LA
Kerkhoff
Division of Cardiology, Stony Brook University School of Medicine, Stony Brook, NY.
Javed
J
Butler
Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, GA.
Anita A
AA
Kelkar
Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, GA.
Supriya
S
Shore
Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, GA.
Candace D
CD
Speight
Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, GA.
Louisa K
LK
Wall
Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, GA Department of Epidemiology, Emory University Rollins School of Public Health, Atlanta, GA njr@emory.edu.
Neal W
NW
Dickert
D002318:Cardiovascular Diseases; D032984:Ethics, Research; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D010342:Patient Acceptance of Health Care / Q000706:statistics & numerical data; D018579:Patient Selection / Q000941:ethics; D016032:Randomized Controlled Trials as Topic / Q000941:ethics*; D013997:Time Factors
clinical trial; informed consent; recruitment; research ethics; trials