A multi-state model analysis of the time from ethical approval to publication of clinical research studies

Abstract

Background Results of medical research should be made publicly available in a timely manner to enable patients and health professionals to make informed decisions about health issues. We aimed to apply a multi-state model to analyze the overall time needed to publish study results, and to examine predictors of the timing of transitions within the research process from study initiation through completion/discontinuation to eventual publication. Methods Using a newly developed multi-state model approach, we analysed the effect of different study-related factors on each of the transitions from study approval to eventual publication, using a data set of clinical studies approved by a German research ethics committee between 2000 and 2002. Results Of 917 approved studies, 806 were included in our analyses. About half of the clinical studies which began were subsequently published as full articles, and the median time from study approval to publication was 10 years. Differences across model states were apparent; several factors were predictive of the transition from study approval to completion, while funding source and collaboration were predictive of the transition from completion to publication. Conclusions The proposed multi-state model approach permits a more comprehensive analysis of time to publication than a simple examination of the transition from approval to publication, and

Technological advances in preclinical meta-research

“…Comparing the life cycle of clinical trial research to the life cycle of animal trial research, from inception to completion, we can see that in clinical research, the median interval between the ethical application and the posting of results on clinicaltrials.gov is between 5 and 7 years, as demonstrated by Blümle et al . 47 To estimate this in preclinical research, we can look at publications which acknowledge, for example, Medical Research Council (UK) as a funder and an intention to conduct animal research in Gateway to Research ( https://gtr.ukri.org/ ). We identified the median interval between grant awarded and publication was 1 year (0–3 year range); we estimate approximately 12 months per experiment.…”