The creation of an integrated Clinical Practice Research Datalink (CPRD) in the UK, combined with a new emphasis on innovation in the National Health Service, has “cleared the path for technology companies at all levels to unlock the value of health data”, say PA Consulting Group and 4D Biomedical.
The consultancies were reporting on the findings of an annual translational-medicine ‘foresighting’ event, held earlier this year in Cambridge, UK.
They concluded that translational medicine, involving the integration of clinical data and insight into the biomedical development process at an earlier stage, is “finally delivering on its promise of facilitating the creation and development of effective medicines that lead to better outcomes for patients”.
A Consulting and 4D Biomedical formed a strategic alliance in February 2010 to support new collaborations between NHS Trusts, biomedical research universities and industry.
The partnership aims to release the value of the UK’s patient data reservoir and clinical science infrastructure while addressing the increasing timelines, cost and failure rate of pharmaceutical R&D.
A £60 million government programme launched last spring and hosted by the Medicines and Healthcare Products Regulatory Agency, the CPRD combines the resources of the General Practice Research Database, which has been collecting anonymised longitudinal medical records from primary care since 1987, and the Research Capability Programme piloted over four years by the National Institute for Health Research.
The Datalink will seek to 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.
According to PA Consulting and 4D Biomedical, the benefits of translational medicine have historically been constrained by limited access to clinical data, a lack of appropriate informatics tools to integrate and interrogate these data, and the need for new business models that allow stakeholders to realise translational value.
Optimising the value of the NHS is crucial to the success of translational medicine, the report says, and it sees encouraging signs both in terms of societal attitudes to the use of patient data in research and of technological advances to combine data from multiple sources.
Patient data use
Peter Knight from the UK’s Department of Health, who spoke at the forecasting event, cites research showing that fewer than 1% of patients would opt out of having their data used “where identifiers flow to a safe haven to support life sciences research”.
Subject to consultation, the government plans to amend the NHS Constitution so that patient data would be “automatically included” in clinical research, with an opt-out provision to address concerns about data privacy and/or security.
The PA/4D report also identifies “real progress” at the local, regional and national levels in technological advances towards integrating multisource health data.
At local level, for example, clinical academic organisations such as King’s College London are pulling together data from multiple hospitals, allowing clinicians to make better decisions about treatments and patient management.
Regionally, development initiatives such as the Manchester-based North West eHealth (NWeH) are “providing secure environments for aggregating, anonymising and analysing health-related data for defined populations”, the consultancies note.
This collaboration between the University of Manchester, Salford Royal Foundation Trust and Salford Primary Care Trust has enabled the NHS organisations, together with local general practices and pharmacies, to provide GlaxoSmithKline with the material for real-world drug trials in chronic obstructive pulmonary disease and asthma.
At the national level, large-scale data processing “is being made more practicable by highly scalable and relatively low-cost cloud computing platforms such as Google BigTable and BigQuery”, PA and 4D point out.
The right model
In terms of new business models, attendees at the PA and 4D event indicated that the life science industry is now thinking about health value propositions that demand the integration of products, technology and services, the hosts report.
One example is a collaboration between Arizona State University and Pfizer, which will work together over four years, in an initiative sponsored by the US National Institutes of Health, to discover biomarkers that help to predict cardiovascular disease and assess potential new treatments in people with type 2 diabetes.
This kind of arrangement suggests a need both for mechanisms that deliver appropriate value to contributing partners (academia, industry and healthcare providers) and for innovation in the approaches partners take to funding the research, PA and 4D suggest.
“As increasing external investment is put into R&D, the industry will need to be more agile in the way it accesses and funds the data it requires,” they comment. “This will be particularly evident as we shift from a price-based reimbursement model to one of predicated outcomes and risk sharing.”
A likely scenario, PA and 4D believe, is “an upstream shift toward risk-based investment as well as in development, promoting earlier collaborations between those with the clinical data and those with the drugs”.
As more attention is paid to translational medicine initiatives, they warn, “we need to ensure we have the systems and processes that value each of the partner’s contributions”.