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Preregistration for All Medical Animal Research

Neuroskeptic iconNeuroskepticBy NeuroskepticJul 23, 2014 9:13 PM

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Writing in the European Journal of Clinical Investigation, three Dutch researchers say that All preclinical trials should be registered in advance in an online registry

Citing the fact that all clinical trials are (in theory) already registered, authors Jansen of Lorkeers et al say that the system should be extended to cover preclinical medical research, which generally means research on laboratory animals -

Publication bias is a major concern in clinical and preclinical trials... In case of preclinical data, meta-analyses can help transition of therapies from bench to bedside... Publication bias is detrimental, since it skews the mean outcome of meta-analyses. In animal studies of stroke, publication bias relatively overestimates the efficacy of interventions by 31%.

They therefore say that

To improve transition of research from preclinical setting towards clinical application and to reduce the number of laboratory animals used, effort should be made to reduce publication bias. We believe that the first step for preclinical studies is a convenient and easy one: prospective registration of preclinical trials. We propose that the registration includes at least a description of the study (including the interventions), a power calculation, number of animals to be included in the study, the duration of the follow up and the primary and secondary outcomes... As it is for clinical trials, prospective registration of preclinical trials should be a requirement for journals publishing the results of these studies.

In calling for the mandatory preregistration of preclinical studies, Jansen of Lorkeers et al are on the right side of history - although they're not the first to make such a call. I did, six years ago, in my Registration: Not Just For Clinical Trials. However the authors make the interesting new point that, in the case of animal research, introducing preregistration could be achieved simply by re-purposing the study proposals which researchers already have to submit (in advance) to their national animal research welfare committees. In the UK, for instance, this is a function of the Home Office under the ASPA legislation. If these proposals were only to be standardized and made publicly available (perhaps after a grace period to prevent other researchers 'stealing the idea'), that would constitute preregistration and would, at a stroke, reduce publication bias greatly.

Jansen of Lorkeers, S., Doevendans, P., & Chamuleau, S. (2014). All preclinical trials should be registered in advance in an online registry European Journal of Clinical Investigation DOI: 10.1111/eci.12299

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