Science and Technology CommitteeSupplementary written evidence submitted by the Department of Health

When I gave evidence on 3 June for the Committee’s inquiry on Clinical Trials, I undertook to provide further information on a number of points.

HRA Feasibility StudyTimetable (Q184)

The Health Research Authority (HRA) has a programme of work to unify the approval process for research and promote consistent and proportionate standards for compliance and inspection. As part of this programme, the Authority began a study in January 2013, to assess the feasibility of rationalising and combining elements of legal and management review with elements of research ethics committee review into a single assessment by the HRA. This would allow NHS organisations to rely on the single review and to decide whether to host a research project swiftly, based solely on local capacity and capability. The findings are expected to identify, and show how to realise: potential to reduce study set-up times, improve the quality and consistency of ethical review, and simplify the approvals process thus reducing the effort and costs involved for researchers. The HRA Board is due to consider the findings of the feasibility study on 24 June. A timetable for implementation is expected to be agreed later in the summer 2013.

Alongside the single assessment review work, a new technical platform for the Integrated Research Application System (IRAS) is being procured for release in early 2015. The new technical platform for IRAS, along with new information systems supporting the research ethics service, will provide an integrated application and approval system enabling communication between review bodies about research applications to be held in one place. This will improve transparency of the review process and make it easier for researchers to navigate the approvals system.

UK Clinical Trials Gateway (Q186–7)

The Department has invested from 2008 to date a total of £611,000 in the UK Clinical Trials Gateway. These costs include: the development work of the database and website, limited advertising and promotional materials, and administrative costs for Editorial Group.

The staffing of the UK Clinical Trials Gateway is provided via contract under arrangement with the University of Leeds, as part of the National Institute for Health Research. The support and development of the UK Clinical Trials Gateway is part of the duties of a team of staff at the University, which equates to two whole time equivalents. In addition, two Department officials support the Editorial Group as part of their overall duties.

The volume of access to the website for May 2013 is: 41,115 pages viewed by 11,570 unique visitors, who visited the site 13,069 times in total. Additionally, accessing the mobile phone and tablet version of UK Clinical Trials Gateway there have been approximately 8,500 downloads of the application since the launch in 2011.

The launch was promoted via leaflets and other printed materials including postcards and posters. In line with Government policy there has not been high level advertising of the system, but it has been promoted at numerous relevant events and recommended in speeches by the Prime Minister, DH Ministers and senior officials. Both the website and the specifically-developed downloadable application for the iPhone, iPad and Android devices have been promoted by INVOLVE (the NIHR-funded Patient and Public Involvement body) at a number of events including the recent “It’s OK to Ask” launch on international clinical trials day (20 May 2013), which aims to prompt to patients and clinicians the importance of life sciences research.

Clinical Trials DatabasesEngagement with Cancer Research UK (Q190)

The Department of Health established an Editorial Group for the UK Clinical Trials Gateway with a membership that represents: patients and the public; Industry, the charitable sector and officials from the Department. Cancer Research UK has been a long standing member of the Editorial Group and has advised, with a range of stakeholders, on the original development of the UK Clinical Trials Gateway database, website design and promotional materials.

European Medicines Agency Advisory Groups (Q212)

Kent Woods, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA), attended the workshop organised by the European Medicines Agency (EMA) on 22 November 2012, on clinical trial data and transparency in his capacity as chair of the EMA Management Board. This was held in order to gather the views, interests and concerns of a range of institutions, groups and individuals with an interest in the topic. Officials from the Department and the MHRA were not present at subsequent advisory groups. The MHRA are looking forward to seeing the draft transparency policy from the EMA, and officials intend to respond to the consultation that is due to start this month. The MHRA will contribute to the further development and agreement of the policy through the relevant committees, including Commission for Human Medicinal Product (CHMP). MHRA officials have also been heavily involved in the working groups established to determine the modalities for publication of the summaries of result from clinical trials held on EudraCT.

The UK environment for clinical trials and transparency in clinical trial data are issues of great importance to the Government, and I look forward to seeing the Committee’s conclusions and recommendations.

June 2013

Prepared 16th September 2013