Who refuses enrollment in cardiac clinical trials?

Objective To evaluate the factors associated with refusal to participate in acute cardiac clinical trials. Background Cardiac clinical trials in the acute setting pose a set of unique challenges to enrollment, such as the ability to obtain meaningful informed consent. In addition, it is unclear whether enrollment is associated with the sociodemographic characteristics (such as age, race and gender) of those being recruited. While policies have been instituted to enhance the representation of women and minorities in research, limited data exist on current enrollment patterns and reasons for refusal to participate in cardiac clinical trials. Methods 184 patients approached to participate in one of 25 cardiac clinical trials at Duke University Medical Center from 11/01 to 05/04 were surveyed regarding reasons for or against participation in clinical trials to identify predictors of non-enrollment. Results The mean age of the respondents was 61.6 years (SD 12.2), with 36% female and 32% non-white patients. There were no differences in refusal rates by age, gender or ethnicity. Higher acuity trials had higher refusal rates OR 3.6 (1.68—7.75) as well as not reading the informed consent form OR 2.99 (1.37—6.54). The main reasons people refused enrollment were due to inconvenience and not wanting to be experimented upon. Limitations This study was cross-sectional and conducted at a single institution that conducts a high-volume of clinical research. In addition, a majority of the patients in the procedure/device studies were enrolled in one relatively low-risk cardiac catheterization laboratory trial with a low refusal rate. These attributes may limit the generalizability of the findings reported here. Conclusion Older persons, women and minorities are equally likely to agree to enroll in cardiac clinical trials as younger persons, men and non-minorities. Future efforts to increase the efficiency of recruitment should focus on improving convenience for participants in this acute setting and improving basic understanding of clinical trials. Clinical Trials 2007; 4: 258—263; http://ctj.sagepub.com References 1. Sugarman J. Is the emperor really wearing new clothes? Informed consent for acute coronary syndromes. Am Heart J 2000; 140: 2—3. 2. Kucia AM, Horowitz JD. Is informed consent to clinical trials an “upside selective” process in acute coronary syndromes? Am Heart J 1999; 140: 94—97. 3. Williams BF, French JK, White HD, and the HERO-2 consent substudy investigators. Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): a prospective observational study. Lancet 2003; 361(9361): 918—22. 4. Kahn JP, Mastroianni AM, Sugarman J eds. Beyond consent: seeking justice in research. New York: Oxford University Press, 1998. 5. National Institutes of Health. NIH guidelines on the inclusion of women and minorities as subjects in clinical research. Fed Regist 1994; 59: 14508. 6. Food and Drug Administration (FDA) Modernization Act of 1997 (FDAMA or the Act), Pub. L.No.105—115, 21 November, 1997. 7. Lee PY, Alexander KP, Hammill BG, Pasquali SK, Peterson ED. Representation of elderly persons and women in published randomized trials of acute coronary syndromes. JAMA 2001; 286(6): 708—13. 8. East MA, Peterson ED. Understanding racial differences in cardiovascular care and outcomes: issues for the new millennium. Am Heart J 2000; 139(5): 764—6. 9. Hack TF, Degner LF, Dyck DA. Relationship between preferences for decision control and illness information among women with breast cancer: a quantitative and qualitative analysis. Soc Sci Med 1994; 39: 279—289. 10. Peterson E, Lytle BL, Biswas MS, Coombs L. Willingness to participate in cardiac trials. Am J Geriatr Cardiol 2004 Jan—Feb; 13(1): 11—5. 11. Wendler D, Kington R, Madans J, et al. Are racial and ethnic minorities less willing to participate in health research? PLoS Med 2006; 3: 201—210. 12. King SB III, Barnhart HX, Kosinshi AS et al. Angioplasty or surgery for multivessel coronary artery disease: comparison of eligible registry and radonized patients in the EAST trial and influence of treatment selection on outcomes. Emorg Angioplasty versus Surgery Trial Investigators Am J Cardiol 1997; 79(11): 1453—9. 13. Williams BF, French JK, White HD. Is our method of obtaining consent appropriate for randomised controlled trials in acute myocardial infarction? N Z Med J 1997; 110: 298—299. 14. Ockene IS, Miner J, Shannon TA, et al. The consent process in the Thrombolytics in Myocardial infarction (TIMI-phase I) trial. Clin Res 1991; 39: 13—17. 15. Agard A, Hermeren G, Herlitz J. Patient's experiences of intervention trials on the treatment of myocardial infarction: is it time to adjust the informed consent procedure to the patient's capacity? Heart 1986; 2001: 632—637.