Abstract
Often the most difficult task in a clinical trial involves obtaining sufficient study participants within a reasonable time. Time is a critical factor for both scientific and logistical reasons. From a scientific viewpoint, there is an optimal window of time within which a clinical trial can and should be completed. Changes in medical practice, including introduction of new treatment options, may make the trial outdated before it is completed. Other investigators may answer the questions sooner. In terms of logistics, the longer recruitment extends beyond the initially allotted recruitment periods, the greater the pressure becomes to meet the goal. Lagging recruitment will also reduce the statistical power of the trial. Costs increase, frustration, and discouragement often follow. The primary reasons for recruitment failure include overoptimistic expectations, failure to start on time, inadequate planning, and insufficient effort.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
ECRI Health Technology Assessment Information Service. Patients’ reasons for participation in clinical trials and effect of trial participation on patient outcomes. ECRI Evidence Report. April 2002, Issue 74.
Wright JR, Crooks D, Ellis PM, et al. Factors that influence the recruitment of patients to phase III studies in oncology. The perspective of the clinical research assistant. Cancer 2002;95:1584–1591.
Cox K, McGarry J. Why patients don’t take part in cancer clinical trials: an overview of the literature. Eur J Cancer Care 2003;12:114–122.
Sharp L, Cotton SC, Alexander L, et al. on behalf of the TOMBOLA group. Reasons for participation and non-participation in a randomized controlled trial: postal questionnaire surveys of women eligible for TOMBOLA (Trial of Management of Borderline and Other Low-grade Abnormal smears). Clin Trials 2006;3:431–442.
Barnes K. Patients provide insight into trial participation. Outsourcing-Pharma.com, July 4, 2007. www.outsourcing-pharma.com/content/view/print/135930.
Mills EJ, Seely D, Rachlis B, et al. Barriers to participation in clinical trials of cancer: a meta-analysis and systematic review of patient-reported factors. Lancet Oncol 2006;7:141–148.
Lovato LC, Hill K, Hertert S, et al. Recruitment for controlled clinical trials: literature summary and annotated bibliography. Control Clin Trials 1997;18:328–357.
McDonald AM, Knight RC, Campbell MK, et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials 2006;7:9.
Watson JM, Torgerson DJ. Increasing recruitment to randomised trials: a review of randomised controlled trials. BMC Med Res Methodol doi:10.1186/1471-2288-6-34 (published 19 July 2006).
Kääriäinen I, Sipponen P, Siurala M. What fraction of hospital ulcer patients is eligible for prospective drug trials? Scand J Gastroenterol 1991;186:73–76.
Sheldon T. Dutch neurologist found guilty of fraud after falsifying 438 case records. Br Med J 2002;325:734.
Ross DB. The FDA and the case of Ketek. N Engl J Med 2007;356:1601–1604.
POISE Study Group. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet 2008;371:1839–1847 (Web attachment 1).
Hunninghake DB. Summary conclusions. Control Clin Trials 1987;8:1S–5S.
Kingry C, Bastien A, Booth G, et al. for the ACCORD Study Group. Recruitment strategies in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Trial. Am J Cardiol 2007;99(Suppl):68i–79i.
Hulley SB, Furberg CD, Gurland B, et al. Systolic Hypertension in the Elderly Program (SHEP): antihypertensive efficacy of chlorthalidone. Am J Cardiol 1985;56:913–920.
Cosgrove N, Borhani NO, Bailey G, et al. Mass mailing and staff experience in a total recruitment program for a clinical trial: the SHEP experience. Control Clin Trials 1999;19:133–148.
Bryant J, Powell J. Payment to healthcare professionals for patient recruitment to trials: a systematic review. Br Med J 2005;331:1377–1378.
Freedman LS, Simon R, Foulkes MA, et al. Inclusion of women and minorities in clinical trials and the NIH Revitalization Act of 1993 – the perspective of NIH clinical trialists. Control Clin Trials 1995;16:277–285.
Cook ED, Moody-Thomas S, Anderson KB, et al. Minority recruitment to the Selenium and Vitamin E Cancer Prevention Trial (SELECT). Clin Trials 2005;2:436–442.
Shibata M, Flather M, de Arenaza DP, et al. Potential impact of socioeconomic differences on clinical outcomes in international clinical trials. Am Heart J 2001;1411:1019–1024.
Orlandini A, Diaz R, Wojdyla D, et al. Outcomes of patients in clinical trials with ST-segment elevation myocardial infarction among countries with different gross national incomes. Eur Heart J 2006;27:527–533.
O’Shea JC, Califf RM. International differences in cardiovascular clinical trials. Am Heart J 2001;141:866–874.
Vickers A, Goyal N, Harland R, Rees R. Do certain countries produce only positive results? A systematic review of controlled trials. Control Clin Trials 1998;19:159–166.
Durkin DA, Kjelsberg MO, Buist AS, et al. Recruitment of participants in the Lung Health Study, I: description of methods. Control Clin Trials 1993;14:20S–37S.
Daly M, Seay J, Balshem A, et al. Feasibility of a telephone survey to recruit health maintenance organization members into a tamoxifen chemoprevention trial. Cancer Epidemiol Biomarkers Prev 1992;1:413–416.
Fields WS, Lemak NA, Frankowski RF, et al. Controlled trial of aspirin in cerebral ischemia. Stroke 1977;8:301–314.
The Coronary Drug Project Research Group. The Coronary Drug Project: design, methods, and baseline results. Circulation 1973;47:I-1–I-50.
The Coronary Drug Project Research Group. Clofibrate and niacin in coronary heart disease. JAMA 1975;231:360–381.
Sackett DL. A compliance practicum for the busy practitioner. In Haynes RB, Taylor DW, Sackett DL (eds.). Compliance in Health Care. Baltimore: Johns Hopkins University Press, 1979.
Julian D. The data monitoring experience in the Carvedilol Post-Infarct Survival Control in Left Ventricular Dysfunction Study: hazards of changing primary outcomes. In DeMets DL, Furberg CD, Friedman LM (eds.). Data Monitoring in Clinical Trials. New York: Springer, 2006, pp. 337–345.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
Copyright information
© 2010 Springer New York
About this chapter
Cite this chapter
Friedman, L.M., Furberg, C.D., DeMets, D.L. (2010). Recruitment of Study Participants. In: Fundamentals of Clinical Trials. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-1586-3_10
Download citation
DOI: https://doi.org/10.1007/978-1-4419-1586-3_10
Published:
Publisher Name: Springer, New York, NY
Print ISBN: 978-1-4419-1585-6
Online ISBN: 978-1-4419-1586-3
eBook Packages: Mathematics and StatisticsMathematics and Statistics (R0)