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.
Dr Janet Wisely, Chief Executive at the HRA, said:
"The HRA welcomes the publication of these guidelines, which provide a robust source of guidance to Research Ethics Committees on insurance in Phase I clinical trials and will help to ensure that the interests of volunteers are properly protected."
Stephen Whitehead, Chief Executive at the ABPI, said:
"Building on the original ABPI insurance guidance, we are pleased to develop with our partner associations, the joint ABPI-BIA-CCRA guidance. Appropriate insurance arrangements recognise the role of volunteers in developing new medicines and we believe the template will provide clear information to regulators."
Glyn Edwards, Interim Chief Executive at the BIA, said:
"This guidance recognises the importance of volunteers in the development of new treatments and is another step to demonstrating that the UK remains a key location for conducting clinical trials. The use of the template document should help accelerate the initiation of trials and the BIA recommends its use to our members."
Professor Atholl Johnston, President of the CCRA, said:
"We welcome the publication of these guidelines which, again, underline the UK's commitment to the highest standards in clinical trials where safeguarding the interests of volunteers is a prime concern.
"The use of the template will add to the excellent initiatives already in place to speed the commencement of clinical trials in the UK."