Clinical trials data: lack of transparency brings health risk, say MPs

In a report published earlier this week, the UK parliament's Science and Technology Committee said greater transparency is needed from clinical trials after research found that the results of clinical trials are only published in around half of cases.

According to the committee, the lack of transparency risks eroding patients' goodwill towards participation in trials and poses a public health risk.

Norman Lamb, chair of the committee called on the Health Research Authority (HRA) in England to "act now to ensure current regulations are enforced and impose tough sanctions on those who seem to think it is acceptable to disregard valuable research, threaten research integrity and, in some cases, endanger human life".

"Many of these trials are funded with public money and the tax payer has a right to expect those who benefit from public funding to follow the rules and publish in full," Lamb said.

A study investigating compliance with requirements to report results on the EU Clinical Trials Register (EU CTR) was published in the British Medical Journal earlier this year. It revealed that just 49.5% of the 7,274 trials identified from the EU CTR as due to publish results had actually done so.

The report revealed a mixed picture; the pharmaceutical industry is generally proficient in publishing timely results from its trials, but the MPs reserved criticism for universities and health bodies after finding the results of clinical trials they organise are less likely to be reported.

"The framework for transparency and reporting of clinical trial data is there," said life sciences expert Helen Cline of Pinsent Masons, the law firm behind Out-Law.com. "Clearly, however, more work needs to be done to ensure that non-commercial sponsors are aware of their disclosure obligations and what they need to do to comply."

"Also, while the momentum internationally to drive transparency of clinical trial data has positives for all stakeholders, it is important that patients retain trust in the system both in terms of protection and use of their data, particularly any commercialisation," she said.

Chris Martin, an expert in legal compliance in the universities sector at Pinsent Masons, said that universities he has worked with have "taken their obligations as sponsor very seriously and have invested significant amounts of time and capital in carrying out and managing trials in a compliant manner".

There are currently a number of rules in place governing clinical trials reporting. The European Commission has required all trials of medicinal products registered on the EU CTR to post results to the registry within a year of completing the trials.

This requirement is also reflected in a code of practice set by the Association of the British Pharmaceutical Industry in the UK which requires its members to publish all clinical trial results within one year of marketing authorisation and publically register new clinical trials within 21 days of the first patient being enrolled. The code requirements are aligned to a further code established by the International Federation of Pharmaceutical Manufacturers and Associations. 

The European Medicines Agency (EMA) has also a policy on the publication of clinical data. This is limited to centrally authorised products.

New transparency requirements for clinical trials are set out in the EU's Clinical Trials Regulation but have yet to take effect. Although the Regulation was finalised in 2014, a new EU-wide portal and database envisaged for holding information relevant to clinical trials has yet to be completed, holding up the transparency rules from being applied.

According to the committee's report, the European Commission is likely to confirm in 2019 that the portal and database are "fully functional" and that this is likely to occur after the UK leaves the EU on 29 March 2019. It will be six months from the date of confirmation that the transparency requirements will apply in EU countries.

The UK government has confirmed that it plans to "align" UK law with the Regulation "without delay when it does come into force in the EU, subject to usual parliamentary approvals". The Science and Technology Committee, however, called on the government to "explicitly commit to introducing the clinical trials transparency requirements in the EU Clinical Trials Regulation" into UK law "shortly after" Brexit.

Although it is the Medicines and Healthcare products Regulatory Agency (MHRA) that is responsible for ensuring that sponsors provide results for drug trials carried out in the UK that are registered in the EU CTR, the report highlighted that not all clinical trials are registered.

In England, the HRA has also taken steps to encourage clinical trials sponsors to pre-register their trials. In 2013 it made it a condition that trials are registered, or a deferral requested, to obtain a 'favourable opinion' from a research ethics committee prior to recruiting participants. HRA's powers are limited, but it can carry out audits of compliance with the registration requirements and can withhold ethical permissions should sponsors have failed previously to meet their obligations.

However, the report by the Science and Technology Committee said that the HRA "appears to be reluctant to enforce its rules, or to make previous compliance with transparency legislation a pre-requisite for ethical approval of future trials". This means there are "no sanctions imposed on sponsors or investigators who fail to comply with HRA rules, or even on those who fail to respond to the HRA when their non-compliance is queried", it said.

The committee called on the HRA to "publish, by December 2019, a detailed strategy for achieving full clinical trials transparency, with a clear deadline and milestones for achieving this". It also said the HRA should be given funding to set up a "national audit programme of clinical trials transparency, including the publication of a single official list of which UK trials have published results and those which are due to but have not", and further called on the government to consider introducing new laws to give the HRA the power to fine the organisers of clinical trials if they fail to publish the results of their trials.