HRA must continue ‘progress towards clinical trial transparency’

The registration of Phase I trials was under scrutiny during a recent judicial review

Campaigners and industry leaders have urged the Health Research Authority to ensure that its work to bring about full transparency in pharma-sponsored clinical trials is not derailed by its recent legal case.

The groups also urged the Health Research Authority (HRA) to not “let the distraction of the judicial review derail you from achieving key objectives”, and to ‘quickly clarify the wording’ of the contentious Q&A document on its website that was the subject of a High Court challenge wrangle.

The HRA was the subject of a legal challenge by an early-stage clinical research organisation. The company sought a judicial review against the trial ethics approval body, which it argued had acted ‘unlawfully’ by implying – in the wording of the Q&A document – that registration of clinical trials was a legal requirement for pharma companies and CROs.

A judge ruled that the industry does have an ethical obligation to register trials – backing a central part of the industry’s transparency agenda – but ruled that the Q&A and some of the HRA’s materials explaining the requirements were ‘confusing’.

The Ethical Medicines Industry Group (EMIG) and transparency campaigners Sense About Science have both spoken out in support of the HRA. EMIG’s earlier call to action – published on Pharmafile – rallied support for transparency during the judicial review in July, while Sense About Science were present in court as an ‘interested party’ in the case.

In a joint letter to HRA chief executive Dr Janet Wisely, published today, the two groups say much of the pharma industry is “convinced of the importance of trustworthy, reliable information about trials to the future of the sector, its investors and customers.”

The letter adds: “While you will need to review your website, critically, you will not need to change your objectives for research transparency, which will play a key role to safeguard patients, as well as build public confidence and greater involvement and participation in health research.”

The settlement is still being negotiated, and lawyers representing the CRO expect the bill for legal costs – which the judge ruled the HRA will have to pay – is likely to run into the tens of thousands.

Lilian Anekwe