Confronting the ‘danger’ of blocking progress on clinical trial transparency

pharmafile | August 19, 2015 | Feature | Research and Development EMIG, Ethical Medicines Industry Group, Richmond Pharmacology, clinical trial registration, clinical trial transparency, health research authority, hra, sense about science, transparency 

The Ethical Medicines Industry Group and Sense About Science – a co-founder of the ALLTrials campaign – have written a joint letter, in support of the Health Research Authority’s work to bring about greater transparency in clinical trials to the industry. 

In a statement, the two bodies say the recent Court has shown “that there are people who want to reverse its recent attempts to do so.”

There is a danger that politicians and others will see this backward-looking view as significant and representative of industry. It isn’t. 

Monitoring compliance is one of the biggest challenges of trials transparency. The HRA had found a sensible, practical way to integrate 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.

In this open letter to the HRA, AllTrials and the Ethical Medicines Industry Group make it clear that AllTrials supporters, the UK biopharmaceutical industry and the English courts have all agreed that it is. 

It demonstrates that forward-looking members of the industry do not want to be associated with destructive opposition to such measures to safeguard patients. EMIG director Mark Edwards says, “This highlights the critical importance of diverse organisations, like ours, working together in a balanced manner to progress key issues affecting human health”.

The letter in full:

To the Chief Executive of the Health Research Authority Dr Janet Wisely

by email

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 I 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.

Yours sincerely

Mark Edwards, EMIG

Tracey Brown, Sense About Science

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