Sample size determinations in original research protocols for randomised clinical trials submitted to UK research ethics committees: review.

ABSTRACT:

Objectives

To assess the completeness of reporting of sample size determinations in unpublished research protocols and to develop guidance for research ethics committees and for statisticians advising these committees.

Design

Review of original research protocols.

Study selection

Unpublished research protocols for phase IIb, III, and IV randomised clinical trials of investigational medicinal products submitted to research ethics committees in the United Kingdom during 1 January to 31 December 2009.

Main outcome measures

Completeness of reporting of the sample size determination, including the justification of design assumptions, and disagreement between reported and recalculated sample size.

Results

446 study protocols were reviewed. Of these, 190 (43%)

SUBMITTER: Clark T 

PROVIDER: S-EPMC3604970 | biostudies-literature | 2013 Mar

REPOSITORIES: biostudies-literature