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Archived News

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Press release: MHRA invites researchers to access our data
ISAC application form updated
GPRD Forthcoming Event - 'Undertaking Research and Analysis Using GPRD Data: the GPRD-MRC Initiative'
New procedures for the scientific review of protocols for research using GPRD data
GPRD Forthcoming Event - 'Undertaking Research and Analysis Using GPRD Flat File Data'
ISAC News
ISAC (Independent Scientific Advisory Committee)
Services - GPRD Risk Management Knowledge and Tracking
Collaboration between MRC & GPRD
2nd Annual GPRD Symposium, British Museum, London, UK
Collaboration between MRC & GPRD announced
Report on GPRD's 4th User Group
GPRD welcomes Susan Eaton to the team
GPRD Newsletters
New study in Lancet looks at link between MMR and Autism
Follow up information and source data verification

Press release: MHRA invites researchers to access our data

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. Please click here for more details.

ISAC application form updated

The GPRD ISAC application form has been further updated to request additional information on study protocols. The new requirements will be mandatory as of 15th September 2007. Please click here for more details.

GPRD Forthcoming Event - 'Undertaking Research and Analysis Using GPRD Data: the GPRD-MRC Initiative'

On 18^th June 2007 GPRD will be hosting 'Undertaking Research and Analysis Using GPRD data: the GPRD-MRC Initiative' at Market Towers, London. The Keynote addess will be made by the GPRD Head of Research, Tjeerd van Staa. Topics covered on the day will include 'Guidelines for protocols and submission', 'Structure and format of the data', 'Data management techniques/routines', 'Preparation of data for analysis' and 'Simple analyses: Incidence and Prevalance'.

To register your interest, please contact our GPRD Team:

Tarita Murray-Thomas
Email: Tarita.Murray-Thomas@mhra.gsi.gov.uk
Tel: 020 7084 2013 Or

Susan Soanes
Email: susan.soanes@mhra.gsi.gov.uk
Tel: 020 7084 2206

Event Fee
Academic £50

New procedures for the scientific review of protocols for research using GPRD data

Following a review of existing procedures, the procedure for submission of protocols to ISAC is to change as of Monday 10^th July 2006. The new procedures are intended to improve efficiency and maintain the current rapid turnaround times for protocol review, especially in light of the increasing volume of protocols being submitted as a result of the success of the agreement with the MRC which provides free access to GPRD data for UK-based academics.

All procedures submitted from this date onwards will be required to follow new “Instructions on Content of Protocols”, drawn up by the GPRD Group in consultation with ISAC. These instructions, which are broadly based on the ISPE’s Good Pharmacoepidemiology Practices, are being implemented in order to ensure that the issues considered essential for ISAC evaluation are covered in the protocol.

At the same time, an updated application form is being introduced; this includes a checklist on protocol content which must be completed prior to submission of the application, as well as some additional questions on the experience and expertise available within the team undertaking the proposed research.

The Instructions on Content of Protocols and updated application form are now available on the ISAC page and must be used for all new protocols submitted from Monday 10^th July 2006 . Protocols submitted from this date which do not use the updated form, or follow the instructions for protocol content, may be returned to the applicant.

Protocols submitted prior to this date can continue to use the existing application form and protocol guidance or use the updated application form, in which case the protocol will need to comply with the new Instructions on Content of Protocols.

If you have any questions about the new procedures, please contact the ISAC Secretariat.

GPRD Forthcoming Event - 'Undertaking Research and Analysis Using GPRD Flat File Data'

On 21^st August 2006 GPRD will be hosting 'Undertaking Research and Analysis Using GPRD Flat File Data' at Market Towers, London. The Keynote addess will be made by the GPRD Head of Research, Tjeerd van Staa. Topics covered on the day will include 'Guidelines for protocols and submission', 'Structure and format of the data', 'Data management techniques/routines', 'Preparation of data for analysis' and 'Simple analyses: Incidence and Prevalance'.

For details on cost and how to register your interest, please click here.

ISAC News

ISAC have now taken over responsibility for the scientific review of protocols for research using GPRD data from SEAG. For further information, including the ISAC application form, please click here.

ISAC (Independent Scientific Advisory Committee)

GPRD’s Scientific and Ethical Advisory Group (SEAG) is being replaced by a new committee (ISAC: Independent Scientific Advisory Committee for MHRA database research) in February 2006. Upon the establishment of ISAC, responsibility for the scientific review of protocols for research using GPRD data will pass to this new committee; the committee will commence protocol review on the 1^st March 2006, following their first meeting in late February.

In order to facilitate the handover of responsibilities to ISAC, SEAG will stop accepting new protocols for review on the 15^th February 2006. All GPRD protocols submitted for review after this date should be submitted to the ISAC in-box (ISAC@gprd.com) and will be reviewed by this new committee. Please note that any protocols submitted between the 15^th - 28^th February 2006 will not be circulated for review until the beginning of March 2006, with a consequent increase in the normal 3 week turnaround time for these protocols.

For further information, including the ISAC application form, please click here.

Services - GPRD Risk Management Knowledge and Tracking

Risk Management- Regulatory requirements- The role of GPRD

The Risk Management plan now required by regulators for new products, dose/formulation changes, indication changes and emerging safety issues requires the collection of real world usage on the product and potentially comparators in the same class.

GPRD, the world’s largest, most validated, longitudinal observational dataset is an ideal vehicle in which to meet these regulatory requirements. Specifically there is a new service from the GPRD team that provides cubes of data tailored to your need. The service delivers highly detailed information to enable you to provide the required data to regulators, the data as specified in the products Risk Management Plan.

Additionally the new service also includes the provision of detailed real world information on the therapy area before launch (change to formulation, etc.) that is required for the Pharmacovigilance specification.

These two new services are called GPRD Risk Management Knowledge and Tracking and provide you with a range of options that will enable the following Tracking scenarios:

Full launch with 6% of all UK tracking.
Restricted GP monitored launch with 100% tracking (GP Sentinel)
Hospital restricted diagnosis/starting drug with restricted GP prescribing- 100% tracking (Hospital/GP sentinel)

As the most granular of observational datasets GPRD can provide extraordinary depths of information that will ensure you can give the required detail in the Pharmacovigilance specification and enable a complete understanding of the real world patients in whom your drug is initially used.

The GPRD Risk Management Knowledge and Tracking service is available for your in-house staff to undertake the required work or on a full service basis with the work being done by the GPRD team.

Pricing is made on a case by case basis.

Please contact Jon Ford at jon.ford@gprd.com for further information.

Collaboration between MRC & GPRD

We are pleased to announce that we are now able to receive applications from UK academics for free access to the GPRD under the recently-signed MRC licence. Please click here for further details on eligibility and the application process.

2nd Annual GPRD Symposium, British Museum, London, UK

The second annual GPRD Symposium (entitled “The power of patient data for public health research”) was held at the British Museum on 18th October 2005. The meeting was well attended with representatives from a variety of different areas including academia, the pharmaceutical industry, NHS and other government departments and regulatory agencies. Speakers from each of these areas and from as far afield as Europe and North America presented examples of their work using the GPRD database, illustrating the wide range of uses for which the data can be used.

The meeting was opened by Professor Kent Woods, Chief Executive of the MHRA and chaired by Professor Sir Alasdair Breckenridge, Chairman. The first speaker was Dr John Parkinson, the new Head of GPRD who described some of the challenges facing the GPRD arising from the changing environment in which it operates, and presented part of his vision for how the database would be developed in order to continue to meet customer needs.

The keynote address, given by Dr David Armstrong, Chair of the MRC’s Health Services and Public Health Research Board, focussed on the announcement of an exciting collaboration between the MRC and the GPRD Group which will provide free access to GPRD data for up to 50 studies a year to be conducted by UK academics (see here for further information).

Mr Nick Andrews (Health Protection Agency: HPA) presented several vaccine safety studies to illustrate how the GPRD is used at the HPA. Dr Bharat Thakar (Roche) described how the GPRD is used in the company’s drug safety department, focussing on the practicalities of using the database on-line.

The ability to use GPRD data to investigate high profile drug safety issues was illustrated by Dr Hershel Jick (Boston Collaborative Drug Surveillance Program) who presented a number of the significant safety studies undertaken by his group since the introduction of the GPRD and by Professor Edeltraut Garbe (Charité University Hospital, Berlin), who described an investigation of the association between COX-2 inhibitors and myocardial infarction. Professor Samy Suissa ( McGill University) also presented his group’s study into the association between medication use and community acquired clostridium difficile infection.

Dr Ian Wong (Centre for Paediatric Pharmacy Research) outlined his work using the GPRD to study the prescribing of psychotropic medications in children. Dr Tim Williams (GPRD Group) also presented on the use of GPRD to investigate drug utilisation, focussing on the prescribing of methylphenidate in primary care.

The final theme for presentations was the use of GPRD in disease epidemiology. Dr Martin Frisher ( Keele University) presented an investigation of the association between psychiatric illness and substance abuse. Ms Arlene Gallagher (GPRD Group) described the use of the GPRD to investigate outcomes of end stage renal disease, a disease more commonly managed in secondary care but capable of research using data from within the GPRD. Finally, Dr Susan Eaton (GPRD Group) presented an investigation of the occurrence, natural history and treatment of restless legs syndrome, which is a condition causing a high level of debilitation yet with no highly effective treatments.

We would like to thank all our speakers, and everyone who attended the symposium and contributed to an interesting and stimulating meeting.

Collaboration between MRC & GPRD announced

A collaboration between the MRC and the GPRD, allowing UK academics free access to GPRD data, was announced at the GPRD 2nd Annual Symposium on 18th October 2005, by Dr David Armstrong (Chair, MRC Health Services and Public Health Research Board). The licence funded by the MRC will cover free provision of GPRD data to academics for up to 50 projects each year, for five years. It will also pay for a support team within the GPRD Group who will work with academics to discuss their data requirements and to extract and provide the data. This collaboration is an exciting development for the GPRD Group and the MRC and we have already started to receive queries from academics who wish to access GPRD data under the terms of the licence.

As discussed at the symposium, it is anticipated that the licence will be finalised within the next few weeks. Following this we will need to recruit additional staff to the GPRD Group in order to provide the support service for academics wishing to use the data under the MRC licence.

We therefore expect to be in a position to review requests for access to GPRD data under the MRC licence early in the New Year. Further details of the procedure, including an application form, will be made available on the GPRD website when we confirm the date from which applications can be made. Updates will be given via the GPRD and MRC websites: watch this space!

Report on GPRD's 4th User Group

The GPRD Group held the 4th GPRD User’s Group Session in Nashville, TN on 21st August 2005 prior to the opening of the 21st International Conference on PharmacoEpidemiology (ICPE) with more than 60 people attending.

Susan Eaton, U.S. representative, led the meeting and gave a welcome address with latest news from GPRD including the announcement of John Parkinson as new Head of the GPRD Group. John joins GPRD with a wealth of experience across healthcare and pharmaceutical medicine from within both academia and industry. His PhD is in computational biochemistry from the University of Liverpool. At Nicholas Laboratories, now part of Roche, he developed a novel information system on aminoglycoside antibiotics widely used in UK hospitals. At JWT Healthcare, he was responsible for working with Pfizer, Wellcome, Glaxo, GD Searle, and others. From 1988 he developed an extensive range of medical education programmes for both pharma companies and medical charities with the University of Dundee. In 1995 he joined MEMO as Client Services Director, responsible for managing relationships with study sponsors and users of data, developing new cost-effective ways of managing data flow, developing methods to assess patient compliance, and providing input to ensure compliance with confidentiality and privacy law. He provided consultancy to UK government agencies on databases, record linkage and suitability of data for research. Recently he has been working with others from ISPE to seek changes to the Declaration of Helsinki clarifying the position of non-interventional pharmacoepidemiology whilst ensuring privacy for persons contributing data.

He brings this wealth of experience at a time when databases are increasing their value to both pharma/biotech/devices companies, healthcare providers as well as academics. Ensuring Good Epidemiological Practice is and will be a must with John.

Emma Heeley (GPRD) presented on Clinical and Therapy Terminology used in GPRD – Recording and Extraction describing current clinical and therapy terminology in GPRD, and strategies for creating code sets defining diseases. The Quality Outcomes Framework (QOF) and its implications for improved recording for 10 key chronic diseases was discussed. Future changes in U.K. clinical and therapy terminology due to the NHS program for IT (NPfIT) and NHS Connecting for Health were discussed. SNOMEDCT ( UK edition) will be used across all healthcare in the UK to record clinical events and the Dictionary of Medicines and Devices (Dm+d) for therapy information. Emma also presented The use of GPRD for estimating prevalence of acute versus chronic diseases showing how aspects of longitudinal data can affect prevalence or incidence.

Arlene Gallagher (GPRD) walked users through Identifying referrals and hospital attendance. The role of the GP in the referral process in the UK was described with practical considerations when investigating referrals and hospital attendance using GPRD data.

Tim Williams (GPRD) presented on Test data - Gift and a Curse? Nearly 90% of GPRD practices receive laboratory data electronically from their local lab. This is great news but does not mean we do not have to remain aware results can be reported in different units and have differing normal ranges.

Three GPRD users presented on practical consideration from their experience with GPRD. Tarek Hammad (FDA) discussed Practical aspects of retrieving data from GPRD. John Logie (GSK) presented on difficulties associated with seemingly simple questions titled Describing drug use on GPRD. Susan Jick (Boston Collaborative Drug Surveillance Program) gave a presentation on how to confirm researchers have correctly defined conditions in studies titled Know your data – validation for individual studies with the new online access.

The GPRD team was thrilled with the turnout and level of interest from those who attended. Our thanks to all those who participated in this productive meeting.

GPRD welcomes Susan Eaton to the team

The GPRD group are delighted to welcome Susan Eaton, M.S.P.H, M.T. (A.S.C.P.) as the newest recruit to the team. This appointment is made in recognition of the growing number of GPRD customers based on the North American continent. Susan will be the Head of GPRD Customer Services, North America. She will temporarily be located in the GPRD’s London office but will soon be based in the U.S. In this role, she will work with current and potential GPRD customers to meet their research needs by providing a variety of services including information about the GPRD database, costs and services, training, assistance with protocols and studies.

Susan has more than 10 years of experience in the pharmaceutical industry. Most recently, Susan was Director of Epidemiology Research in the Epidemiology group at RTI Health Solutions. Prior to joining RTI in October 2001, she was a Principal Epidemiologic Scientist in Worldwide Epidemiology at GlaxoSmithKline (GSK). Before joining GSK, Susan worked in the Clinical Research and Statistical Programming Groups at Quintiles.

Susan has been involved in the planning and conduct of large observational databases for clinical, epidemiology, and outcome studies, population projection models, disease natural history studies, and prospective naturalistic studies. Whilst at GSK, her work focused on ways to house and use large observational databases such as the GPRD to answer a variety of research questions and on Epidemiological needs within the Metabolic and Diabetes drug area. Susan will start work with GPRD on 15 March 2005 and can be contacted at susan.eaton@gprd.com.

GPRD Newsletters

To download any of the following, simply right click and select 'save target as...'.
The newsletters will require Adobe Acrobat reader.

Click here to view the latest newsletter - GPRD Newsletter - Issue 6 (364kb)

Previous Newsletters

If you have any problems downloading or viewing the above files please email admin@gprd.com

New study in Lancet looks at link between MMR and Autism

In the recent edition of the Lancet, a review looking at the links between the MMR vacination and Autism has been published. Currently the largest study of its kind, it was undertaken by reviewing the data held in the GPRD between the dates of June 1st 1987 and Dec 31st 2001. A full copy of the study can be viewed at the Lancet website.

The new GPRD bibliography, comprising over 400 published studies, is also available and can be downloaded here.

GPRD Bibliography

Follow up information and source data verification

Thinking of using GPRD or developing a protocol for a study? Want to know more about the UK primary care system, the NHS or the data recording practices of GPs? Might these affect the feasibility or design of your study?

Dr Mike Lockwood, a retired Vision GP, is available to provide consultancy advice on such topics. Mike's former practice has been contributing data to the GPRD since it began and he was a longstanding member of SEAG before it changed to ISAC. Mike also contributes to the training provided to new Licensees.

This service is open to any GPRD user or prospective user, whether they obtain GPRD data from the GPRD group or not. The fee is £85 per hour or £700 per day.

Access to the service is available via admin@gprd.com.