Premature Discontinuation of Prospective Clinical Studies Approved by a Research Ethics Committee - A Comparison of Randomised and Non-Randomised Studies.

ABSTRACT:

Background

Premature discontinuation of clinical studies affects about 25% of randomised controlled trials (RCTs) which raises concerns about waste of scarce resources for research. The risk of discontinuation of non-randomised prospective studies (NPSs) is yet unclear.

Objectives

To compare the proportion of discontinued studies between NPSs and RCTs that received ethical approval.

Methods

We systematically surveyed prospective longitudinal clinical studies that were approved by a single REC in Freiburg, Germany between 2000 and 2002. We collected study characteristics, identified subsequent publications, and surveyed investigators to elucidate whether a study was discontinued and, if so, why.

Results

Of 917 approved studies, 547 were prospective longitudinal

SUBMITTER: Blumle A 

PROVIDER: S-EPMC5085068 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature