Research ethics committee decision-making in relation to an efficient neonatal trial.

ABSTRACT:

Objective

Randomised controlled trials, a gold-standard approach to reduce uncertainties in clinical practice, are growing in cost and are often slow to recruit. We determined whether methodological approaches to facilitate large, efficient clinical trials were acceptable to UK research ethics committees (RECs).

Design

We developed a protocol in collaboration with parents, for a comparative-effectiveness, randomised controlled trial comparing two widely used blood transfusion practices in preterm infants. We incorporated four approaches to improve recruitment and efficiency: (i) point-of-care design using electronic patient records for patient identification, randomisation and data acquisition, (ii) short two-page information sheet; (iii) explicit mention of possible inclusi

SUBMITTER: Gale C 

PROVIDER: S-EPMC5537508 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature