UK Phase I clinical trials insurance guidance published

Three UK trade groups, the Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIA) and the Clinical Contract Research Association (CCRA), yesterday 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 organizations 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.