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

Trials
Rebecca Llewellyn-BennettLouise Bowman

Abstract

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). 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 controlled trials (more than 1000 adult participants) published from March 2006 to April 2017 were evaluated. Two reviewers screened and extracted data attaining > 95% concordance of papers checked. Assessment of bias in the trials was evaluated using the Cochrane Risk of Bias tool. Fifty-seven thousand three hundred and fifty-two papers were identified and 65 trials which had post-trial follow-up (PTFU) were included in the analysis. The majority of trials used more than one t...Continue Reading

References

Sep 21, 2002·BMJ : British Medical Journal·Dean FergussonPaul Hébert
Aug 23, 2003·Journal of Epidemiology and Community Health·P ScuffhamR Legood
Apr 20, 2011·The American Journal of Gastroenterology·Nadir ArberBernard Levin
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Mar 25, 2017·International Journal of Epidemiology·Annie HerbertPia Hardelid

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Citations

Apr 9, 2019·Medical Decision Making : an International Journal of the Society for Medical Decision Making·Bethan CopseyJonathan A Cook
Apr 9, 2020·Clinical Trials : Journal of the Society for Clinical Trials·Lars G Hemkens
Aug 18, 2020·Clinical Nutrition : Official Journal of the European Society of Parenteral and Enteral Nutrition·Sadaf Oliai AraghiNathalie van der Velde

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