In the recent judicial review against the Health Research Authority (HRA), the UK’s ethical approval body for clinical trials, a clinical trials company tried to challenge the HRA’s attempts to monitor whether applicants are registering all their trials. Despite the Court’s judgment – that the HRA has a clear legal right to monitor researchers’ compliance with all their legal and ethical obligations – we cannot ignore the fact that there are people who want to undermine that progress. There is a danger that politicians and others will see this backward view as significant and representative of industry.
To make it clear that it is no such thing, AllTrials and the Ethical Medicines Industry Group have today sent a joint letter to the HRA, setting out why it should not be dissuaded from its path. The story is published in Pharmafile today.
Monitoring compliance with regulations and good practice is one of the biggest challenges of trials transparency. Medical journals tell us that they still receive submissions from studies that have not been registered, and recent reviews have found big gaps in compliance on trial registries. The HRA had found a sensible and practical way of integrating some basic monitoring into the ethical approval process that they’re responsible for. Regulatory bodies in other countries have been considering whether it is a way forward.
We hope our letter will also make it very clear to them that AllTrials supporters, the UK biopharmaceutical industry, and the English courts have all agreed that it is.
To the Chief Executive of the Health Research Authority Dr Janet Wisely, by email, on 19th August 2015:
Dear Dr Wisely
The Health Research Authority’s work on promoting clinical trial registration has been a model of well thought out, collaborative progress towards transparency. You have developed an approach that integrates transparent trial registration into the existing procedures to protect patients and participants, making it efficient and achievable for commercial and non-commercial trialists and sponsors. Organisations in the UK and internationally are looking to you to continue that leadership.
We and many others were therefore pleased to see the judge’s statements in the Judicial Review against you last month: that the HRA has a clear legal right to monitor researchers’ compliance with their legal and ethical obligations when running clinical trials. During your consultations with industry, academia, patient groups and the public about this, you noted the broadly held expectation that the HRA’s role should include checking researchers’ compliance with obligations. The court recognised that trial registration is a fundamental ethical obligation and the judge expressed surprise that the HRA doesn’t currently sanction researchers who don’t fulfil that obligation. The response received by EMIG to its recent letter in Pharmafile demonstrates that you have support in the biopharmaceutical industry for a positive and well-managed transparency policy which achieves this. Many members of the sector are now convinced of the importance of trustworthy, reliable information about trials to the future of the sector, its investors and customers.
We are disappointed that the transparency policy on your website was found by the court to be ambiguous and is in need of clarification to make it lawful. Although we recognise that there are unlikely in fact to be any adult Phase 1 trials affected by it, ie registered before September 2013 and still recruiting in April 2015, we share the court’s expectation that you will quickly clarify the wording. But 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.
We therefore urge you, as a small organisation with limited resources, under no circumstances to let the distraction of the judicial review derail you from achieving these key objectives.
Mark Edwards, EMIG
Tracey Brown, Sense About Science
Organisations all over the world, such as the Office for Human Research Protections in the US, the Federal Institute for Drugs and Medicines in Germany, and the Brazilian National Health Surveillance Agency should all read this letter, to name just a few. If you have dealings with people at organisations such as these, please help us to make them aware of the letter.