Publication of clinical trial data and results continues to be a hot topic in the EU. A recent BMJ article investigated the level of compliance with the European Commission’s requirement that the results of all trials are published within 12 months of completion. The Commission guidance expands on the obligations in the Clinical Trials Directive, and states that for all trials (paediatric and non-paediatric), result-related information should be supplied and made public within 12 months of the completion of the trial (not after grant of the marketing authorisation), including a summary of the results and conclusions.

The retrospective cohort study found that despite the Commission guidance, of the 7,274 trials where results were due, only 49.5% reported results, although trials with a commercial sponsor were substantially more likely to post results than those with a non-commercial sponsor (68.1% compared to 11.0%).

Last time a report such as this was published, it led to a number of cases being commenced by the UK PMCPA, which administers the ABPI Code of Practice. Many of the self-regulatory codes in the EU refer to the EFPIA “Joint Principles” on clinical trial transparency, and state that companies should disclose details of clinical trials in accordance with the Joint Principles. As such, the PMPCA followed-up with a number of companies to question their compliance with the transparency provisions. Similar enquires are being made by the PMCPA following this recent BMJ article.

In addition, the matter has been raised in the UK Parliament. At the end of October, the Science and Technology Committee published a report expressing concern that nearly half of clinical trials fail to publish their results. While the report emphasises the lack of compliance by universities and NHS hospitals, it is generally critical of the level of reporting of results. It further notes its concern about “selective non-publication—‘or publication bias’—of results” and the risk of the effects of such “bias” on the views of the medicines in clinical practice.

Specific recommendations are directed at the Health Research Authority (HRA), which manages the ethics committees for clinical trials in the UK. Specifically, the Committee recommends that the HRA:

  • publishes a detailed strategy for achieving full clinical trial transparency, with a clear deadline and milestones
  • be provided with funding to establish a national programme to audit clinical trial transparency
  • introduces a system of sanctions to drive improvements in clinical trial transparency, such as withdrawing favourable ethical opinions or preventing further trials from taking place, and the Government consult on whether to provide the HRA with the statutory power to fine sponsors for non-compliance.

It is currently uncertain if the UK legislation will change as a result of these recommendations, or whether there will be further enforcement via the PMCPA. However, it seems clear that there will be more scrutiny on reporting results from clinical trials in the near future.