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

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 res

SUBMITTER: Peters-Lawrence MH 

PROVIDER: S-EPMC3577351 | biostudies-literature | 2012 Mar

REPOSITORIES: biostudies-literature