A feature of medical research is that clinical trials are often carried out by those hoping to manufacture and market a particular drug for a particular condition. Researchers have an obvious incentive to ensure that favourable tests are published. They have no such incentive to publish inconclusive or negative tests. The fact that according to the AllTrials campaign over half of clinical trials have never been published gives rise to concerns about so-called “publication bias”, namely that unfavourable trials are reported much less often than are favourable trials. This is concerning, as it can lead to duplication of effort, a failure to obtain a full picture of results for sampling purposes, and may even result in ineffective drugs being marketed or dangerous side effects not being understood.

In a recent judgment in the case of R (Richmond Pharmacology Limited) v The Health Research Authority [2015] EWHC 2238 (Admin), the High Court helpfully clarified the duties on those conducting and sponsoring early stage clinical trials in the United Kingdom, and the scope of the Health Research Authority’s remit in promoting and protecting the interests of patients in clinical research and streamlining research regulation.

The Health Research Authority (“HRA”), the body governing clinical trials in England, has sought to introduce guidelines requiring the results of clinical trials conducted here to be published to improve transparency. These moves have been welcomed by the AllTrials campaign and were aimed at putting England in the forefront of clinical transparency. In what appeared to be a major setback to the advancement of clinical research transparency, Richmond Pharmacology (“Richmond”), a clinical research company which carries out a wide range of early phase clinical trials, sought to challenge certain guidelines issued by the HRA by applying for judicial review. The Court granted permission to bring the judicial review in respect of only some of the grounds relied upon by Richmond.

Initially, Richmond sought to curtail the HRA’s remit and to challenge the HRA’s proposals to require that upon applying to register early-stage clinical trials, those conducting and sponsoring the trial certify that previously authorised on-going trials had been registered.  Richmond argued that in the absence of a legal requirement to publish clinical trial data on those sponsoring and conducting clinical trials, the HRA could not impose retrospective registration. Notably, during the course of the proceedings Richmond substantially departed from its initial arguments.

Fearing that the wider point of principle would be lost in a narrow discussion about procedure, Sense about Science (a leading part of the AllTrials campaign) sought and obtained leave to intervene in these proceedings to make the Court aware of the wide-ranging public interest implications of its potential decision.

The matter was heard on 16 July 2015, and judgment was handed down by Mr. Justice Jay on 28 July 2015. The Judge significantly narrowed the issues, effectively dismissing all but one of the grounds relied upon by Richmond. The ground which remained, and in respect of which the Judge gave his ruling, was introduced by Richmond a few weeks before trial and was limited to an objection to certain statements made by the HRA on its website. Richmond’s approach to the proceedings in failing to properly formulate its case until late in the day, was reflected in the Court’s order dealing with costs of the proceedings, with recovery of a large part of Richmond’s costs being disallowed.

Whilst the Court held that the HRA had acted unlawfully by giving ambiguous and potentially misleading advice in its website materials as to whether the duty to register and publish trials lay in ethics or in law, it also provided a much needed clarification of the HRA’s remit – a welcome result for Sense about Science and the clinical research community.

The Court recognised that the HRA is legally entitled to take into account both legal and ethical obligations when carrying out its functions, and is entitled therefore to require public registration of clinical trials and to impose sanctions for breach, provided it does so in a clear and transparent manner.

It is hoped that further clarity and harmonisation in this area will follow the introduction of the EU Clinical Trial Regulation No. 536/2014 in May 2016.

 Jonathan Price