Patient Retention in a Clinical Trial: A Lesson from the Rofecoxib (VIOXX) Study
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A high retention rate of patients and control subjects is an important criterion for the credibility and accuracy of prospective, randomized, controlled clinical trials. Retention and adherence depend on a combination of patient-, physician- and coordinator-related factors, and these need to be carefully evaluated to ensure success. The aim of the study was to evaluate predictive factors for patient retention in a clinical trial. Questionnaires containing items on demographic and clinical data and specific questions related to patient motivation were distributed to 31 patients participating in a clinical study comparing rofecoxib (Vioxx) and placebo for the prevention of colonic polyp recurrence. Adherence of the group with the rofecoxib study and the questionnaire was 100%. The sample included 24 men (77%) and 7 women of mean age 66 ± 9 years; 90% were married, 42% were employed. A family history of colorectal cancer (CRC) was reported by 29%. The main reasons for adherence reported by the patients (on an analog scale of 0–10) were 24-hour availability of a nurse (9.2 ± 1.9), the chance to prevent CRC (9.1 ± 1.9), and participation in a multicenter study (9.1 ± 2.2). The least important factor was support of the family physician (5.8 ± 4.1). In conclusion, retention in a clinical trial mainly depends on the subject of the trial and the scientific/professional setting where it takes place, and less on the support of the family physician.
Keywordspatient retention clinical trial medical research
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- 6.Froelicher ES, Miller NH, Buzaitis A, et al.: The Enhancing Recovery in Coronary Heart Disease Trial (ENRICHD): strategies and techniques for enhancing retention of patients with acute myocardial infarction and depression or social isolation. J Cardiopulm Rehabil 23:269–280, 2003PubMedCrossRefGoogle Scholar
- 7.Parra-Medina D, D'Antonio A, Smith SM, et al.: Successful recruitment and retention strategies for a randomized weight management trial for people with diabetes living in rural, medically underserved counties of South Carolina: the POWER study. J Am Diet Assoc 104:70–75, 2004PubMedCrossRefGoogle Scholar