A judicial review brought by a clinical research company against the Health Research Authority (HRA), challenging the steps that the clinical trials regulator took to monitor the registration of clinical trials, has been upheld by a High Court judge in a judgement published on 28 July 2015.
The dispute focused on changes made by the HRA requiring companies seeking approval for new trials to commit to publishing the results of all previous trials. In September 2013, the HRA made the registration of a clinical trial a condition of approval to run that trial. From April 2015, it has asked researchers applying to run a clinical trial to declare that all past trials have been registered, including those approved before September 2013.
Lawyers representing the pharmaceutical company Richmond Pharmacology argued that the retrospective change was unlawful. The ruling means that companies sponsoring phase I clinical trials in the UK retain control over whether and when they make public the registration of previously conducted trials, they say.
In upholding the judicial review, heard in Manchester on 16 July 2015, Mr Justice Jay said that the HRA must be clear about what constitutes guidance and what constitutes legal obligations. “A legal obligation flows from the imposition of a specific requirement of the clinical trials regulations,” he explained.
Janet Wisely, chief executive of the HRA, says it is a “matter of great regret” that there has been a challenge to research transparency in the UK. “The vast majority of our colleagues working within commercial clinical research share our ambitions and commitment to greater research transparency,” she adds.