{"entity":{"id":"idea-bio1-preclinical-preregistration","kind":"idea","name":"Pre-register animal efficacy studies like clinical trials","aka":[],"tldr":"Clinical trials must be registered before they start so that failures cannot be hidden. Animal studies used to justify human trials should follow the same rule.","summary":"Publication bias and flexible analysis inflate preclinical effect sizes; systematic reviews repeatedly find that animal efficacy is overstated relative to later clinical results. A registry requiring the protocol, sample size, randomisation, blinding and primary endpoint before pivotal in vivo efficacy studies, enforced by funders and journals, would make preclinical evidence auditable. The ARRIVE guidelines exist but are advisory.","asOf":"2026-09-08","links":[{"label":"ARRIVE guidelines","url":"https://arriveguidelines.org/"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["nci","cruk"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-preclinical-models","b-reproducibility","b-negative-results"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Pre-registered in vivo efficacy studies report smaller average effect sizes and higher replication rates than unregistered studies, and pre-registration reduces the rate of failed phase 2 trials in programmes that relied on them.","rationale":"Registration reduced positive-result rates in clinical cardiology trials, an effect large enough to be visible; the same incentives operate preclinically with weaker safeguards.","test":"A funder mandates registration for pivotal in vivo studies in its portfolio for three years and compares effect sizes and independent replication with a matched unregistered portfolio.","maturity":"speculative","actor":"policy","cost":"small","horizonYears":4},"route":"/ideas/idea-bio1-preclinical-preregistration/","neighbours":{"institution":[{"id":"cruk","kind":"institution","name":"Cancer Research UK","route":"/institutions/cruk/"},{"id":"nci","kind":"institution","name":"National Cancer Institute (NIH)","route":"/institutions/nci/"}],"bottleneck":[{"id":"b-negative-results","kind":"bottleneck","name":"Failures are hidden","route":"/bottlenecks/b-negative-results/"},{"id":"b-preclinical-models","kind":"bottleneck","name":"Lab models that fail to predict what happens in patients","route":"/bottlenecks/b-preclinical-models/"},{"id":"b-reproducibility","kind":"bottleneck","name":"Preclinical results do not reproduce","route":"/bottlenecks/b-reproducibility/"}]}}