Data Access Proposal Request
Flatiron Health UK RWD Products
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Multiple Myeloma
Attendees
Flatiron Health UK
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Emma Salib (Chair) -
Vanessa Acquaah (Programme manager) -
Adam Manhi (Chair) -
Elsie Horne (Research Scientist) -
Christoph Buhl (Research Oncologist)
Research Transparency Panel
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Kaeden Bunting (lay) -
Jenny McCaffery (lay) -
Trishna Bharadia (patient) -
Thomas Smith (patient) -
Yanrong Jiang (clinical)
Conflicts of interest
No conflicts declared by panel
Decision outcome
Approved
Summary of discussion
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Broad agreement that lay summary was well written, providing a clear and accessible overview of MM, its disease background, current treatment landscape, and the specific unmet needs of patients with relapsed and
refractory MM. -
The summary was deemed understandable to a non-specialist audience and clearly outlined the structure and objectives of the research
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The two-phase structure, Phase 1 as a fit-for-purpose assessment and Phase 2 as direct data access for further analysis, was seen as a logical and practical stepwise approach, with a clear go/no-go decision between phases and was appreciated for its clarity.
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The proposal addresses a clear unmet need in MM research, particularly in supporting more realistic clinical study design.
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The panel raised several comments on other aspects of the application including:
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Additional details on the specific patient populations to be studied would be valuable, particularly to clarify how under-represented groups will be identified and included in the research.
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How are the intentions and outcomes of research disseminated to
patients?-
It was discussed that Pfizer’s advocacy group frequently communicates study information through regular updates, advocacy workshops, and patient engagement training, and will involve patients at the appropriate stage if a clinical study is developed in the future.
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How will Pfizer determine whether Flatiron’s MM data product meets their requirements and is suitable for their intended use?
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It was explained that Pfizer will determine if Flatiron’s product is suitable by assessing whether there are enough MM patients, if the treatment records match what is expected from clinical guidelines, if the key data of interest to Pfizer is present, and if the survival rates match expectations and provide enough information about patient outcomes.
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The panel highlighted that it would be helpful to provide a sample or dummy report illustrating the type of analysis and deliverables that Pfizer would receive from Flatiron following the completion of Phase 1.
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