hra

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.

Flickr/Mike Cogh

Both sides of a bitterly contested legal battle over a major part of the industry's transparency drive have reacted to the judge's verdict.

A judge ruled that the Health Research Authority is acting within the law in pushing through plans for companies to register clinical trials in active recruitment in the UK.

Sense About Science outside court in Manchester for the judicial review (Twitter/Bede Constantinides)

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.

Credit: Bristol-Myers Squibb

A judge will today hear arguments from the Health Research Authority and campaigners who are contesting a judicial review of plans for industry transparency.

Richmond Pharmacology, an early-stage clinical research company, will argue at the administrative court in Manchester that the plans by the Health Research Authority (HRA), the ethical approval body for trials, to require the pharma industry to register all clinical trials are unlawful.

The battle for greater transparency in the pharma industry is to take another twist after a company lodged a legal challenge in an attempt to block a major part of the transparency agenda.

Richmond Pharmacology, a clinical research organisation that conducts Phase I clinical trials on behalf of pharma firms and had a £7.4 million turnover in 2013, has been given permission to bring a judicial review of plans brought in under the EU Clinical Trial Regulation to force companies to register details of studies that take place in the UK.

A new study has shown that public confidence in health research studies can be increased by knowing that patients have advised on the design of the study.

This is according to an Ipsos MORI survey of 1,295 British adults which showed that 44% of respondents thought that involving patients to ensure that the information given to participants was easy to understand, would increase their confidence in the study.

Anyone wanting to conduct clinical trials in the UK will have to register their research in order to receive a ‘favourable ethical opinion’ before they can begin, according to new rules to be introduced at the end of the month.

The Health Research Authority (HRA), whose remit is to protect and promote the interests of patients and the public in health research, is bringing in the plan from 30 September to ensure that UK trials are put onto a public database.