Research Oversight Process
Flatiron Health UK has established this process to govern access to and use of our Real-World Data (RWD) products by academic researchers and commercial partners (i.e. life sciences companies). This process has been approved by the NHS Health Research Authority. If you are interested in accessing our UK data products, please contact us.
Key Purposes
Broadly, the Research Oversight Process comprises a review by an internal panel and a review by an external panel.
Firstly, the internal Feasibility Review Panel ensures scientific validity, methodological feasibility and privacy compliance of access and use of Flatiron Health UK data. This panel is made up of Flatiron’s clinical and data science teams.
Secondly, an external, independent Research Transparency Panel ensures access and use of Flatiron data is in the patient and public interest. This panel is made up of clinicians, patients and lay representatives from across the UK.
Key Process Steps
01
Data Access Request
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Researcher submits data access proposal
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Proposal must demonstrate that research will generate public and patient benefit
02
Feasibility Review Panel
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Panel assesses:
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Scientific validity
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Methodological feasibility
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Data privacy compliance
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Review by Flatiron’s Patient Voices Panel
03
Research Transparency Panel
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Impartial, external committee
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Reviews new use cases for Flatiron data
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Provided with transparency on research results
04
Data Access Decision
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If data access is granted, access is via Flatiron Health UK’s Trusted Research Environment, which includes visualisation and analytical tools. We use centralised logging and all our servers are in the UK.
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Only aggregated data can be downloaded
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Results must be reported within one year.
Note: Health insurers or cigarette manufacturers (as examples) would never be provided with access to the Flatiron Health UK RWD products (as described in our patient privacy notice), so should such requests be received, they would not be accepted through this process.
Documentation
Data Access Register
For transparency, this tracker captures details of projects that have been approved by the Flatiron Health UK Data Access Register.
ORGANISATION
Roche
TARGET DISEASES
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Multiple myeloma
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Diffuse large B-cell lymphoma
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Chronic lymphatic leukemia
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Prostate cancer
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Breast cancer
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Non-small cell lung cancer
INTENDED USE CASES
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Clinical trial design and feasibility
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Health technology assessment, health economics outcomes research, and Market access
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Understanding and monitoring the treatment landscape
DATE OF REQUEST APPROVAL
30th November, 2023
ORGANISATION
Pfizer
TARGET DISEASES
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Breast cancer
INTENDED USE CASES
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Product development and portfolio strategy
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Clinical trial design and feasibility
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Supporting regulatory submissions
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Product launch planning
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Health technology assessment, health economics outcomes research, and Market access
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Label / indication expansion
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Understanding and monitoring the treatment landscape
DATE OF REQUEST APPROVAL
14th December, 2023
ORGANISATION
Gilead
TARGET DISEASES
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Breast cancer
INTENDED USE CASES
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Product launch planning
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Health Technology Assessment (HTA), Health Economics Outcomes Research (HEOR) and Market Access
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Understanding and monitoring treatment landscape
DATE OF REQUEST APPROVAL
4th June, 2024
ORGANISATION
Takeda
TARGET DISEASES
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Colorectal cancer
INTENDED USE CASES
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Health technology assessment, health economics outcomes research, and Market access
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Understanding and monitoring the treatment landscape
DATE OF REQUEST APPROVAL
4th June, 2024
Panel Summaries
Flatiron Health UK will also regularly publish summaries from panel meetings and summarise the outputs of asynchronous reviews. Through this process, Flatiron Health UK will also document and disclose details of unsuccessful applications to access Flatiron Health UK RWD products.
Annual Reports
Flatiron Health UK remains committed to summarising the meeting outputs in an annual research transparency report (written for the lay audience) that will document and describe such use cases (approved and rejected) and the impact of the research.
Note: The Data Access Annual Report for 2023 will be disclosed here following the end of year review.