Clinical trials: Duties to register trials and publish data?

In The Queen (on the application of Richmond Pharmacology Ltd v Health Research Authority & Anor [2015] EWHC 2238 (Admin), Richmond Pharmacology Ltd, R (On the Application Of) v The Health Research Authority [2015] EWHC 2238 (Admin) (28 July 2015), the claimant sought to challenge certain public statements by the Health Research Authority in relation to the latter’s characterisation of the duties of those sponsoring and carrying out clinical trials: specifically, the claimant contends that the Health Research Authority is wrongly asserting that those in its position are under legal duties to register their trials on publicly available websites and to publish data about the outcome of such trials.

The court noted at [70] – [72]:

… the difference between legal and ethical obligations in this specific context is as follows. A legal obligation flows from the imposition of a specific requirement of the Clinical Trials Regulations (see Regulation 28), a breach of which carries with it certain consequences, including an obligation to notify (see Regulation 29A) and criminal sanctions (see Regulation 49). As I have already pointed out, the conditions and principles of good clinical practice fall within this rubric.

An ethical obligation (in this context, being an obligation falling short of amounting to good clinical practice) flows from the application of standards which have national or international backing, including standards which are imposed by the regulator. Furthermore, the regulator would be entitled to set out the consequences of breach of an ethical obligation, although in the present context it has not done so. It is trite law that the entity being regulated is entitled to a clear statement of what those consequences may be.

The vice of muddying the metaphorical waters, and failing to keep these normative streams clear and separate, is that the entity being regulated will not know exactly where it stands in relation to the consequences of any breach.

At [86] the court concluded:

I am not holding that the Defendant has expressly stated that there is a legal obligation in relation to the pre-September 2013 approvals, or that this is clearly to be inferred from what the Defendant has said. I am holding that the Defendant’s public utterances fail the public law test of certainty and transparency as explained in the jurisprudence mentioned under paragraph 48 above. Specifically, I am content to hold that these are (to the extent I have specified) “so ambiguous as to the expression of its scope as to mislead” the informed reader ….

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