Members of the House of Commons Science and Technology Committee made the comments in a report published yesterday that criticised UK Government efforts to make the clinical research process more transparent.
“We consider the current lack of trial transparency to be unacceptable and we have not been impressed by the Government's efforts to resolve this problem to date.
“We ask the Government to enhance its efforts to increase transparency and to consider the recommendations of this Report in preparing its response to the European Medicines Agency's on-going consultation on access to clinical trial data.”
To address this, the committee suggested that all trials conducted in the UK should be registered, including those already conducted, and that “summary-level” results from all research are made publicly available.
“We recommend that trial registration and publication of summary-level results be made contractual requirements for all publicly-funded trials, including those covered by the Charity Research Support Fund, and urge the Government to conduct a retrospective audit of all large public trial grants awarded since 2000 to ensure that they have been registered and published.”
The committee makes an exception for non-commercial studies – i.e. those that are not conducted to assess a drug product – which it suggests need not be published unless they contribute to the development of regulations of further scientific understanding.
In the report the committee also address one of the arguments against mandatory publication of results put forward by industry, namely that such disclosure jeopardizes patient privacy.
“We are not in favour of placing anonymised individual patient-level data (IPD) in the public domain in an unrestricted manner, as the risk to patient confidentiality is too great.
“Instead, specific individuals should be provided with controlled access to IPD through carefully managed and secure "safe havens". Access should be facilitated by an independent "gatekeeper", responsible for ensuring that data is handled responsibly and in a way that makes a useful contribution to scientific knowledge.”
Regulation, regulation, regulation
While transparency is the main focus of the report it is not the only subject covered.
The committee also looked at the regulations that cover clinical research and concluded that the Government could do more to make the UK a more attractive place in which to carry out drug trials.
“The Government has failed to eliminate the biggest barrier to initiating a trial in the UK—the requirement for numerous, and potentially duplicate, governance approvals from participating NHS organisations.”
One key area of concern was the Health research Authority (HRA) – an organisation set up in 2011 to protect the rights of trial participants – whose role is still poorly understood by the drug industry according the committee.
In response HRA chair, Jonathan Montgomery, said: “The HRA will consider the report in more detail before making a more formal response to the individual recommendations.
Pro Montgomery added that: “We welcome the recognition of the HRA's role and have already taken steps in the many of the areas identified by the Committee to improve awareness and promote transparency.”
The criticism of the HRA comes a day after the authority outlined plans to make registration of trials a requirement for ethical approval.
Spokesman Gordon Harrison told Outsourcing-pharma.com that: “As an organisation, we are working to make the UK a global leader for health research.
“We are working closely with a number of partners, which as you would expect includes industry representatives, to make sure the UK becomes more attractive as a destination for research, not less."