TY - JOUR
T1 - Clinical trial implementation and recruitment
T2 - Lessons learned from the early closure of a randomized clinical trial
AU - Peters-Lawrence, Marlene H.
AU - Bell, Margaret C.
AU - Hsu, Lewis L.
AU - Osunkwo, Ifeyinwa
AU - Seaman, Phillip
AU - Blackwood, Miren
AU - Guillaume, Edouard
AU - Bellevue, Rita
AU - Krishnamurti, Lakshmanan
AU - Smith, Wally R.
AU - Dampier, Carlton D.
AU - Minniti, Caterina P.
N1 - 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 . Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health.
PY - 2012/3
Y1 - 2012/3
N2 - 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.
AB - 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.
KW - Clinical trial
KW - Minority
KW - Pain
KW - Protocol development
KW - Recruitment
KW - Sickle cell disease
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U2 - 10.1016/j.cct.2011.11.018
DO - 10.1016/j.cct.2011.11.018
M3 - Article
C2 - 22155024
AN - SCOPUS:84856218422
SN - 1551-7144
VL - 33
SP - 291
EP - 297
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
IS - 2
ER -