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To ask Her Majesty's Government, further to the Written Answer by Earl Howe on 4 May (HL8631), what is their assessment of the impact on patient safety of the use of unlicensed comparators in clinical trials and assessments made by the National Institute for Health and Clinical Excellence.
The identification of an unlicensed comparator for a technology being appraised by the National Institute for Health and Clinical Excellence (NICE) does not constitute a recommendation by NICE for the use of the unlicensed product in question.
Clinical trials will often inevitably involve the administration of products that are, at the time of the trial, unlicensed. The Medicines and Healthcare products Regulatory Agency oversees a rigorous process for the authorisation of clinical trials, including whether or not the product is licensed for use in the clinical condition being investigated in the trial. The potential risks associated with participating in a clinical trial should be explained clearly to potential participants and is part of the process of obtaining their consent to participate in the clinical trial.