Regulatory Focus™ > News Articles > MHRA: New Clinical Practice Database Will Lead to New Ways to Conduct Clinical Trials

MHRA: New Clinical Practice Database Will Lead to New Ways to Conduct Clinical Trials

Posted 04 April 2012 | By Alexander Gaffney, RAC 

The Clinical Practice Research Datalink (CPRD), an anonymized longitudinal medical records database, is being launched to provide the UK life-sciences industry with a "world-class" health service that may well revolutionize the way clinical trials are conducted, the Medicines and Healthcare products Regulatory Agency (MHRA) said in a statement.

The MHRA-managed CPRD "will help researchers to better understand the causes of illness and protect public health while ensuring that the UK is the place for new health research projects," said MHRA in a statement.

CPRD will also "provide novel and powerful ways in which clinical trials can be undertaken," according to MHRA.

The CPRD, launched 29 March 2012, is composed of the General Practice Research Database (GPRD) and the National Institute for Health Research's (NIHR) Research Capability Programme.

"The CPRD is not so much about creating a new reservoir of data as establishing productive relationships between previously siloed datasets in primary, secondary and tertiary care, as well as streamlining the processes through which researchers can access those data," explains Pharma Times.

According to MHRA, the CPRD will include:

  • Data services: Access to data for researchers (NHS, social care and others); data matching and linkage services, data validation and access to real time data to facilitate surveillance activities and support the public health agenda.
  • Interventional research services: Feasibility of research proposal (ie are there enough research subjects in a given area to undertake the study?); site and patient level recruitment; full electronic-data (e-data) services; linkage services for clinical trials, full clinical trial input; biological sample collection and linkage; patient reported outcomes collection and linkage.
  • Research services: Advise on research methodology, research governance and feasibility of research proposals; provide consultancy services including the provision of patient and / or healthcare professional input; ability to undertake research studies on behalf of customers.

Read more:

MHRA - Clinical Practice Research Datalink launches to improve health research

PharmaTimes - Clinical Practice Research Datalink launched in the UK

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