The guidance (available to download here), 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.
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.”
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.”
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.”
For further information, please contact:
ABPI: Andrew Swailes, Media Officer (tel: 020 7747 1441, email: firstname.lastname@example.org)
BIA: Robert Winder, Head of Communications (tel: 020 7565 7193, mobile 07825 942 934, email: email@example.com)
CCRA: Sue Dilks, Director of Operations (tel: 0116 2719727, email: firstname.lastname@example.org)
HRA: David Neal, Deputy Director (Policy), NRES (mobile 07771 673900 or email: email@example.com or HRA office 020 7972 2545)
The National Research Ethics Service announcement along with links to the NRES guidance for research ethics committees, the guidance on insurance and compensation in the event of injury in Phase I clinical trials and the Statement of Insurance Cover template are available on the NRES website.
The Association of the British Pharmaceutical Industry
The ABPI represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK.
Our industry, a major contributor to the economy of the UK, brings life-saving and life-enhancing medicines to patients. Our members supply 90 per cent of all medicines used by the NHS, and are researching and developing over two-thirds of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome diseases.
The ABPI is recognised by government as the industry body negotiating on behalf of the branded pharmaceutical industry, for statutory consultation requirements including the pricing scheme for medicines in the UK.
Health Research Authority
The Health Research Authority (HRA) is a newly formed NHS organisation established as a Special Health Authority on 1 December 2011. Its purpose is to protect and promote the interests of patients and the public in health research.
The National Research Ethics Service (NRES) is the core function of the HRA and consists of the NHS Research Ethics Committees in England, their volunteer members, chairs and supporting staff, and the National Research Ethics Advisers’ Panel. NRES is committed to enabling and supporting ethical research to maximise the benefits of research in the UK. Visit: www.nres.nhs.uk and www.hra.nhs.uk.
Founded over 20 years ago at the infancy of biotechnology, the BioIndustry Association (BIA) is the trade association for innovative enterprises involved in UK bioscience. Members include emerging and more established bioscience companies; pharmaceutical companies; academic, research and philanthropic organisations; and service providers to the bioscience sector. The BIA represents the interests of its members to a broad section of stakeholders, from government and regulators to patient groups and the media. Our goal is to secure the UK's position as a global hub and as the best location for innovative research and commercialisation, enabling our world-leading research base to deliver healthcare solutions that can truly make a difference to people's lives. For further information, please go to www.bioindustry.org.
Clinical Contract Research Association
The Clinical Contract Research Association (CCRA) is the trade association, established in 2003, for all organisations which provide clinical contract development services for the pharmaceutical and biotechnology industries, and their service providers.
CCRA also helps ensure that patients and volunteers receive the very best professional attention and information through every stage of their participation in trials. In adopting the CCRA Code of Practice, a company is guaranteeing to be at the leading edge of study design and to subscribe to a benchmark of excellence. For further information please visit: www.ccra.org.uk.