Publication rate in preclinical research: a plea for preregistrationPublication rate in preclinical research: a plea for preregistration

Abstract

ObjectivesThe ultimate goal of biomedical research is the development of new treatment options for patients. Animal models are used if questions cannot be addressed otherwise. Currently, it is widely believed that a large fraction of performed studies are never published, but there are no data that directly address this question.MethodsWe have tracked a selection of animal study protocols approved in the University Medical Center Utrecht in the Netherlands, to assess whether these have led to a publication with a follow-up period of 7 years.ResultsWe found that 60% of all animal study protocols led to at least one publication (full text or abstract). A total of 5590 animals were used in these studies, of which 26% was reported in the resulting publications.ConclusionsThe data presented here underline the need for preclinical preregistration, in view of the risk of reporting and publication bias in preclinical research. We plea that all animal study protocols should be prospectively registered on an online, accessible platform to increase transparency and data sharing. To facilitate this, we have developed a platform dedicated to animal study protocol registration: www.preclinicaltrials.eu.

Web-based survey among animal researchers on publication practices and incentives for increasing publication rates

“…Based on the survey, we identified additional proposals with confirmed conduction yielding published results, thereby increasing the total publication rate of the original sample from 67% to 70% and the mean number of publications per proposal from 1.44 to 1.50. These findings align with that from a recently published study tracking a selection of animal study protocols approved at the university medical center in Utrecht, The Netherlands, wherein the publication rate was 60% [ 11 ], supporting our contention that a substantial fraction of animal studies remain unpublished. Failure to publish results from animal studies is a matter of concern [ 1 , 3 , 6 , 7 , 12 ], necessitating concrete measures and incentives to improve publication practices.…”

Enteral Feeding Interventions in the Prevention of Necrotizing Enterocolitis: A Systematic Review of Experimental and Clinical Studies

“…The current evidence from animal studies needs to be interpreted with caution, primarily due to the difficulty to adequately assess risk of bias in most animal studies and to determine certainty of evidence. Dissemination bias is likely present in animal studies of NEC, as researchers estimate that, in general, only around 50-60% of conducted animal studies [254,255] and data of only 26% of animals used are published [255]. Importantly, one of the main reasons for not publishing a study appears to be non-statistically significant results [254].…”

“…In future preclinical experiments issues such as timing of intervention and dose/treatment regimen should be taken into account. Negative findings should be published, which could be stimulated by voluntary or mandatory registration of conducted (animal) studies as is more and more common practice in the clinical research field [255]. Moreover, the reporting quality of methodological aspects in experimental studies should be significantly improved to enable fair assessment of risk of bias and certainty of evidence.…”

Increasing the statistical power of animal experiments with historical control data

“…At the same time, it is impossible to pre-define how many high-quality studies are necessary for estimating an optimal parameter. We recommend preregistering prior experiments and their indices on suitable platforms such the Open Science Framework (https://osf.io/), https://preclinicaltrials.eu/ 31 or the Experimental Design Assistant 32 . During preregistration, scientists should define the prior experiments and related indices and should also describe the rationale behind the choice of experiments and planned sensitivity analyses.…”