Post-trial follow-up methodology in large randomised controlled trials: a systematic review.

ABSTRACT:

Background

Randomised controlled clinical trials typically have a relatively brief in-trial follow-up period which can underestimate safety signals and fail to detect long-term hazards, which may take years to appear. Extended follow-up after the scheduled closure of the trial allows detection of both persistent or enhanced beneficial effects following cessation of study treatment (i.e. a legacy effect) and the emergence of possible adverse effects (e.g. development of cancer).

Methods

A systematic review was conducted following PRISMA guidelines to qualitatively compare post-trial follow-up methods used in large randomised controlled trials. Five bibliographic databases, including Medline and the Cochrane Library, and one trial registry were searched. All large randomised c

SUBMITTER: Llewellyn-Bennett R 

PROVIDER: S-EPMC5975470 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature