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Legal issues surrounding clinical trials

Clinical trials solicitors


The serious condition of six men hospitalised following a clinical drugs test has highlighted the difficult legal issues surrounding an adverse reaction during volunteers medical trials. Who should be held responsible in such a case and what recourse do drug trial volunteers have?

Compensation in clinical trials is governed by the EU Clinical Trials Directive implemented in the UK by the Medicine for Human Use (Clinical Trials) Regulations 2004.

Neither this Directive nor the UK Regulations require no fault compensation in clinical trials but the Association of British Pharmaceutical Industry Guidelines for medical experiments in non patient human volunteers (March 1988) offer such a compensation scheme at the manufacturers discretion.

In the event that compensation under an such an indemnity cannot be agreed, then the injured patients will have redress either at common law in a claim for negligence or alternatively in relation to the defective product under the Consumer Protection Act 1987.

Factors which are unknown which will have a bearing on this failed medical trial will be

  • The relationship of the clinical trial to the non human experimental protocol to date
  • The nature of the protocol approved by the relevant Research Ethics Committee
  • The question of whether or not the clinicians supervising the trial adhered sufficiently closely to the protocol
  • Whether there was some drug effect even when that protocol was wholly adhered to, which was incapable of being anticipated by the manufacturer

Clinical trial lawyer

David Body, Head of Medical Law & Patients Rights at Irwin Mitchell commented

Compensation in this case for the patients affected should be straightforward but that depends upon the manufacturer being prepared to quickly accept full responsibility for what has happened.