Randomized clinical trials with run-in periods: frequency, characteristics and reporting

Clinical Epidemiology
David Ruben Teindl LaursenAsbjørn Hróbjartsson

Abstract

Run-in periods are occasionally used in randomized clinical trials to exclude patients after inclusion, but before randomization. In theory, run-in periods increase the probability of detecting a potential treatment effect, at the cost of possibly affecting external and internal validity. Adequate reporting of exclusions during the run-in period is a prerequisite for judging the risk of compromised validity. Our study aims were to assess the proportion of randomized clinical trials with run-in periods, to characterize such trials and the types of run-in periods and to assess their reporting. This was an observational study of 470 PubMed-indexed randomized controlled trial publications from 2014. We compared trials with and without run-in periods, described the types of run-in periods and evaluated the completeness of their reporting by noting whether publications stated the number of excluded patients, reasons for exclusion and baseline characteristics of the excluded patients. Twenty-five trials reported a run-in period (5%). These were larger than other trials (median number of randomized patients 217 vs 90, P=0.01) and more commonly industry trials (11% vs 3%, P<0.01). The run-in procedures varied in design and purpose. In 2...Continue Reading

Citations

Nov 7, 2019·Therapeutic Advances in Respiratory Disease·Jose Luis Lopez-CamposJoan B Soriano
Jan 15, 2021·Molecular Neurodegeneration·Jeffrey Cummings
Oct 2, 2020·Journal of Clinical Epidemiology·David CollisterMichael Walsh
Mar 5, 2021·Journal of Pain Research·Xiao ZhangFengchun Zhang
Mar 26, 2021·The Lancet. Gastroenterology & Hepatology·Michelle BosmanDaniel Keszthelyi
Apr 6, 2021·Alzheimer's & Dementia : Translational Research & Clinical Interventions·Kathy Y LiuRobert Howard
Jun 8, 2021·Contemporary Clinical Trials·David CollisterUNKNOWN ACHIEVE investigators
Jul 5, 2021·The Canadian Journal of Cardiology·Grant W ReedSteven Nissen

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