Preregistration for All Medical Animal Research

By Neuroskeptic | July 23, 2014 12:13 pm

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

fixing_science

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.

ResearchBlogging.orgJansen 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

  • Sarah Hellewell

    I love the idea of this, however I’m not convinced this would reduce publication bias. Even the well planned, experimentally justified, genuinely no differences negative results studies are very difficult to publish, particularly in the case of neuroprotective drug studies. They just don’t have the ‘sexiness’ of positive results. And then there’s the issue of scooping, particularly in small fields in which many groups and examining the same question… I wonder if a better approach might be to pre-register a study with a journal based on the novelty of the question and the scientific validity of the study, with an agreement that, if completed as proposed, the study would be published no matter the result, providing the manuscript is sound.

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Neuroskeptic

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About Neuroskeptic

Neuroskeptic is a British neuroscientist who takes a skeptical look at his own field, and beyond. His blog offers a look at the latest developments in neuroscience, psychiatry and psychology through a critical lens.

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