Contract research organisation Richmond Pharmacology is challenging a decision by the Health Research Authority, part of the UK Department of Health. HRA governs clinical research and supports transparency, including registration of all studies and publication of results.
Last week Sense About Science, the UK charity behind the “All Trials” campaign for access to clinical trial data, announced a counter-attack.
“Our director has instructed lawyers to apply to the Administrative Court to intervene in the judicial review brought by Richmond Pharmacology against the Health Research Authority in respect of clinical trial registration,” Campaigns Manager James Cockerill told supporters in an email.
Judicial review allows a court to examine the lawfulness of a decision made by HRA. The judge may set aside the decision and sometimes award damages, but the judgement will not prevent HRA from making the same decision again, as long as it follows the correct procedure.
In an email to Outsourcing-Pharma.com, Richmond Pharmacology did not share its specific objections to HRA’s transparency decisions, but told us it was “forced” to bring a judicial review because “the HRA has acted unlawfully in respect of the implementation of their transparency policy” on publication of clinical research.
The CRO said transparency regulations should be appropriate for all the countries where trials take place:
“It’s important to design a set of rules that are acceptable and enforceable across most areas where research is performed.”
HRA “persistently refused to consider its legal position, making this stance clear in public meetings,” added a spokesperson.
Campaigners: 'For shame'
Sense About Science said legal action against the CRO was “a difficult decision” for a small charity, “and we intervene with a small but real risk of financial devastation. However, our Board of Trustees and the AllTrials steering group agree that this is our duty.”
Doctor and science writer Ben Goldacre, who campaigns with Sense About Science, reacted to the news of Richmond’s judicial review, tweeting “For shame”:
The pharma world is speculating about the London-based CRO’s motivations in bringing the review. An industry insider told Outsourcing-Pharma.com he was surprised by the news that a small CRO is challenging the legislation. The ten year-old early phase company is based at St George's Hospital, London.
The Administrative Court is set to make a decision in July.