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High Court rules that Health Research Authority acted unlawfully over trial transparency

BMJ 2015; 351 doi: https://doi.org/10.1136/bmj.h4194 (Published 03 August 2015) Cite this as: BMJ 2015;351:h4194
  1. Clare Dyer
  1. 1The BMJ

The Health Research Authority acted unlawfully in giving “misleading” and “confusing” messages to companies carrying out early stage clinical trials about new rules on publicly registering trials, a High Court judge has ruled.1

Mr Justice Jay said that the authority’s public utterances “fail the public law test of certainty and transparency,” which ensures that those who are required to comply with rules can be sure of exactly what requirements they must meet.

The ruling followed a legal challenge by Richmond Pharmacology, a clinical research organisation, to the authority’s transparency requirements on companies carrying out phase I trials, which test the safety and tolerability of new medicines.

The case initially involved broader issues, but it was narrowed down to an argument by Richmond that the authority was …

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