Phase I clinical trials insurance guidance

The Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIA) and the Clinical Contract Research Association (CCRA) have today jointly published guidance on insurance and compensation for Phase I clinical trials. The guidance, which has been developed in consultation with the Department of Health and the National Research Ethics Service (NRES) within the Health Research Authority (HRA), is for trials including first-in-man studies involving healthy volunteers. The guidance also applies to studies conducted in patient volunteers without the target disease to provide additional pharmacokinetic data about the medicine under research.

The guidance is intended for use by Phase I clinical trial sponsors, clinical research organisations and ethics committees. It has been developed to provide authoritative recommendations on the level of insurance and other aspects of insurance cover. The guidance is based on industry best practice and complements wider industry guidance on conducting Phase I clinical studies.

It will provide assurance to volunteers in clinical trials and ethics committees that adequate insurance is in place. This will accelerate the ethics committee review process, enabling clinical trials to start more quickly, and thereby enhancing the clinical development environment in the UK.

Published alongside the guidance is a template Statement of Insurance Cover, which has been developed by NRES, to give clinical trial sponsors a consistent document to provide to the ethics committee. The statement will be incorporated into the standard application for Phase I clinical trials within the Integrated Research Application System for health and social care research in the UK.