Press release: MHRA invites researchers to access our data

Press release

Date:	25 Oct 2007
Time:	10:30
Subject:	First annual report of ISAC
Contact:	Press Office 020 7084 3535/3564 or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189

The Medicines and Healthcare products Regulatory Agency (MHRA) is encouraging those in the research community to apply to use valuable data from the General Practice Research Database (GPRD) and the Yellow Card Scheme to help their studies to protect public health.

The call by the MHRA comes on the publication today of the first ever annual report by the Independent Scientific Advisory Committee (ISAC). ISAC reviews the scientific merit of proposals for research using data from the GPRD and Yellow Card Scheme, whilst protecting the identity and interests of those who have provided the data in confidence. The annual report has seen the review of many challenging and exciting protocols. Topics covered have included genetics, research into long-term conditions, cancer, drug safety and epidemiology. These are illustrative of the wealth of data contained in these two important MHRA databases. The annual report also provides useful information to researchers wishing to apply for data to ensure a smooth journey through the review process.

Professor Sir Alasdair Breckenridge, Chairman of the MHRA said, “The potential of the data we hold at MHRA for public health research is unparalleled and I am delighted that the launch of ISAC’s first report shows that this is increasingly recognised by researchers. Although GPRD data has been available for some time, opening up access to the Yellow Card database was a new venture, and yet another milestone in implementing the recommendations of the Independent Review of Access to Yellow Card data.

“Information on approved studies in the report will help more researchers make successful applications to use MHRA data in the interests of public health.”

Notes to Editor

1. The ISAC is a non-statutory expert advisory body established in 2006 by the Secretary of State to provide advice on research related requests to access data from the GPRD and Yellow Card Scheme. It has the following terms of reference:

1. i. to consider and provide advice to MHRA on applications for Yellow Card data which fall outside Freedom of Information provisions, and all research projects which propose the use of data from the General Practice Research Database;

   ii. to provide advice at the request of the MHRA on wider aspects of the release of Yellow Card data;

2. iii. to advise MHRA on specific uses of data from the General Practice Research Database.

2. The ISAC’s main remit is scientific review, but it can also provide advice about whether ethical review of a study may be warranted. NHS Research Ethics Committees undertake any ethical review.

3. In its first year ISAC has met five times and reviewed a total of 127 GPRD protocols and 4 Yellow Card applications for the first time.

4. More information on the Committee including membership, summary minutes and the annual report are on the MHRA website at
http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=928

5. The GPRD database can provide data from anonymised longitudinal medical records in primary care. Managed by the MHRA, it contains comprehensive observational data from real life clinical practice and provides analytical insight for a wide range of applications in clinical trial, drug safety, outcomes research and clinical epidemiology.

6. The Yellow Card Scheme was set up in 1964 to collect reports on suspected adverse drug reactions (ADRs) to facilitate pharmacovigilance and medicines safety regulation. The ISAC reviews the scientific aspects of requests for Yellow Card data and considers, in particular, the methodology of the study, whether the study is an appropriate use of Yellow Card data, the Freedom Of Information/Data Protection Act implications of releasing data and how the use of other data sources would interact with Yellow Card data.

7. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone –the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.