Company Challenges UK Clinical Trial Transparency Rules

An initiative to increase clinical trial transparency in the UK is being challenged in court after a successful petition by a company that conducts clinical trials for the pharmaceutical companies, The Guardian reports.

Background

The Health Research Authority (HRA) is a recently launched branch of the UK's National Health Service (NHS), tasked with overseeing clinical research and making recommendations on how research is regulated.

While HRA's main mandate is to "protect and promote the interests of patients and the public," the agency also undertakes projects to improve the regulatory environment for clinical research in the UK. One example of this is a plan to simplify how clinical trials are authorized by creating a single application that will "remove the need for NHS permission to be issued by each participating organisation and replace the local R&D approval process." HRA says this new clinical trials approval process will make it easier for companies to launch new studies.

Clinical Trial Transparency

Health authorities are increasingly calling for new measures to improve clinical trial transparency, citing a lack of published results, especially for studies with negative outcomes.

In 2013, HRA published plans for improving clinical trial transparency in the UK. The plans outlined requirements for companies to register clinical trials, public results and ensure that outcomes of studies are publicly accessible. The plans also provided additional requirements for companies to verify compliance with UK clinical trial regulations through a declaration in the study authorization application.

As part of the plans, HRA would publish the outcome of its Research Ethics Committee opinions and other basic information about each study, including its title and point of contact. Companies are also required to provide results to study participants at the conclusion of a study.

HRA says it is also working on additional measures in accordance with the new EU clinical trials regulations which come into effect after May 2016.

Legal Challenge

Reactions in industry to new clinical trials transparency measures have been mixed. Some groups have fought against increased transparency, citing concerns over commercial confidentiality and increased red tape. Others have seen the writing on the wall and have been more accepting of calls for increased transparency.

Now, in the UK, Richmond Pharmacology, a company that conducts clinical trials for pharmaceutical companies, has successfully petitioned to have HRA's clinical trial transparency undergo judicial review.

Síle Lane, director of campaigns at Sense About Science, a group that has pushed for increased transparency in clinical research, told The Guardian, "It is shocking that a company is using court action to try to stop transparency … Hidden and unregistered trials are compromising patient care."

While the challenge has been allowed to proceed, HRA has cautioned that "the merits of the claim are not considered at the permission stage," and says not all of Richmond Pharmacology's grounds were granted.

The Guardian