Clinical trial implementation and recruitment: Lessons learned from the early closure of a randomized clinical trial

• Type of Material: Article
• Authors: Marlene H. Peters-Lawrence, National Institutes of Health; Margaret C. Bell, New England Research Institutes; Lewis L. Hsu, Children’s National Medical Center; Ifeyinwa Osunkwo, Emory University; Phillip Seaman, Johns Hopkins University; Miren Blackwood, Interfaith Medical Center; Edouard Guillaume, Interfaith Medical Center; Rita Bellevue, New York Methodist Hospital; Lakshmanan Krishnamurti, Emory University; Wally R. Smith, Virginia Commonwealth University; Carlton D Dampier, Emory University; Caterina P. Minniti, National Institutes of Health
• Language: English
• Date: 2012-03-01
• Publisher: Elsevier: 12 months
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: Copyright © 2019 Elsevier Inc. All rights reserved.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1016/j.cct.2011.11.018
• Title of Journal or Parent Work: Contemporary Clinical Trials
• ISSN: 1551-7144
• Volume: 33
• Issue: 2
• Start Page: 291
• End Page: 297
• Grant/Funding Information: This publication was made possible by Grant Number U10HL083721; MO1-RR02172; UL1-RR-024134; U54 RR026076; UL1RR031988; UL1RR025747; and intramural funding from the National Heart, Lung, and Blood Institute, National Institutes of Health.
• Keywords: Protocol development; Minority; Research & Experimental Medicine; Medicine, Research & Experimental; Science & Technology; Recruitment; RESEARCH PARTICIPATION; Life Sciences & Biomedicine; Clinical trial; Pain; STRATEGIES; Pharmacology & Pharmacy; PAIN; Sickle cell disease
• Research Categories: Health Sciences, Epidemiology; Health Sciences, Medicine and Surgery; Health Sciences, Pharmacology

Abstract

Background: The NHLBI-sponsored Sickle Cell Disease Clinical Research Network (SCDCRN) conducted a multi-center, acute intervention randomized clinical trial of two methods of Patient Controlled Analgesia for acute pain. This trial was terminated early due to low enrollment. We analyzed the perceived barriers and recruitment difficulties as reported by the coordinators and principal investigators. Methods: Participating sites completed a missed eligibility log of subjects admitted in pain crisis throughout the study and a survey at the end of the trial. The survey covered site-specific factors, policies, and procedures in study implementation, recruitment strategies, and eligibility factors. The New England Research Institutes (NERI) collected de-identified surveys from 31 respondents at 29 of 31 participating sites. Results: From December 2009 to June 2010, 1116 patient encounters for SCD and pain occurred at participating institutions: 38 subjects were enrolled (14 pediatric and 24 adults) and 34 completed the trial, below the projected 278 subjects. Fourteen sites enrolled subjects and seventeen did not. Recruitment barriers included insufficient staff, subject ineligibility or in too much pain to consent, competing protocols, and concerns regarding pain control. Recruitment methods were referrals from urgent care, SCD clinics and in house databases. No use of media or outside physicians was reported. Conclusion: We identified multiple barriers to patient accrual including short duration of enrollment period, protocol design, complex dosing schedule, requirement for staff availability during week-end and after hours, multiple departments' involvement, protocol acceptance, eligibility criteria, competing protocols, and limited staff. Each of these areas should be targeted for intervention in order to plan and conduct successful future clinical trials.