Patient Retention in a Clinical Trial: A Lesson from the Rofecoxib (VIOXX) Study

• Published in: Digestive diseases and sciences Vol. 51; no. 7; pp. 1175 - 1178
• Main Authors: Mor, Meli, Niv, Galia, Niv, Yaron
• Format: Journal Article
• Language: English
• Published: Heidelberg Springer 01.07.2006; Springer Nature B.V
• Subjects: Aged; Aged, 80 and over; Biological and medical sciences; Bones, joints and connective tissue. Antiinflammatory agents; Colonic Polyps - prevention & control; Cyclooxygenase 2 Inhibitors - therapeutic use; Feeding. Feeding behavior; Female; Fundamental and applied biological sciences. Psychology; Humans; Lactones - therapeutic use; Male; Medical sciences; Middle Aged; Multicenter Studies as Topic; Multivariate Analysis; Patient Compliance - statistics & numerical data; Pharmacology. Drug treatments; Physician-Patient Relations; Predictive Value of Tests; Prospective Studies; Quality of Life; Randomized Controlled Trials as Topic; Recurrence; Sulfones - therapeutic use; Surveys and Questionnaires; Treatment Outcome; Vertebrates: anatomy and physiology, studies on body, several organs or systems; Human; Prostaglandin-endoperoxide synthase; Rofecoxib; Enzyme; Enzyme inhibitor; Metabolic diseases; Cyclooxygenase 2 inhibitor; medical research; Non steroidal antiinflammatory agent; patient retention; Scientific research; Gastroenterology; Clinical trial; Oxidoreductases
• ISSN: 0163-2116; 1573-2568
• DOI: 10.1007/s10620-006-8028-5

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.