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. UK-Map-ColourResearchers 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 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.
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