Ruling in transparency case ‘due within days’
pharmafile | July 17, 2015 | News story | Research and Development | EMIG, EU Clinical Trial Regulation, Ethical Medicines Industry Group, Richmond Pharmacology, alltrials, clinical trials, health research authority, hra, sense about science, transparency
A judge is set to rule on a controversial legal challenge to the requirement for the pharma industry to register clinical trials in active recruitment in the UK.
Clinical trials firm Richmond Pharmacology was granted permission to seek the judicial review in May. The UK firm is challenging the Health Research Authority (HRA), which grants ethical approval for clinical trials in the UK, for ‘overstepping its duties’ by requiring companies to register trials before beginning recruitment.
Richmond Pharmacology argued at the judicial review in Manchester that by asking trial sponsors to declare that previous or ongoing trials in the UK are registered, the HRA wrongly implied there was a legal requirement to do so – which the HRA denies.
The argument hinges on whether the wording of a Q&A document explaining the rules around clinical trial registration is accurate with regards to Phase I trials in human, and whether the Q&A made it clear that these trials do not have to be registered until 2016.
Another point of contention is whether trials that were given approval prior to 2013 that were still in active recruitment in April 2015 – when the HRA requirements came into force as part of the EU Clinical Trial Regulation – should be registered.
Lawyers representing the clinical research organisation also argued in court that the HRA’s requirements had resulted in companies were moving clinical trials out of the UK to other European countries.
A decision is expected later in July. In a letter to Pharmafile the Ethical Medicines Industry Group questioned the basis for the judicial review. R&D director Dr Mark Edwards says the ‘erroneous’ case could be ‘hugely damaging’ to the industry’s transparency agenda – and called on others within the industry to speak out against it.
Campaigners were present in court during the judicial review, including Tracey Brown, director of Sense About Science – one of the founding members of the ALLTrials campaign for transparency in clinical trials research.
She told Pharmafile: “I’m pleased with how the judicial review went – though it’s a shame it’s come to this. This is costing tens if thousands of pounds, so a court can decide on whether the words in a Q&A document are potentially misleading to a group of people that we’re not sure exist.”
In a statement the HRA says: “We are awaiting the outcome of today’s hearing and will make a further statement when we are in a position to do so.
“We are grateful that Sense About Science participated in the claim. We are also grateful that the Ethical Medicines Industry Group (EMIG) supported the HRA in the case. We remain committed to promoting greater transparency in research.”
Roche’s Genentech has announced that the phase 3 ALINA trial assessing Alecensa, compared with platinum-based …
GSK has announced positive results today from its first efficacy trial for Shingrix recombinant zoster …