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The first concerns the availability of patient data generated in clinical trials.
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Today is a day to celebrate GSKs decision to share patient-level data from the clinical trials of its approved medicines and discontinued investigational medicines.
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It involves not only the release of clinical trial results but also access to patient-level trial data.
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Last OCTOBER, one of the largest pharmaceutical companies in the world, GSK, announced that it would make patient-level data available and publish the results of both clinical study reports (CSRs) and clinical trials.
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Recently published data by the Lund Report indicates that Kaiser patients enrolled in their patient portal, which includes secure messaging with doctors, access to clinical data, and self-service transactions, are 2.6 times more likely to stay with the organization than those who are do not participate online (see more on avoiding system leakage in ACOs here).
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For each clinical category it releases data on mortality, complication rates, and patient satisfaction.
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Data safety monitoring boards (DSMBs) are chartered to look at data from clinical trials as it comes into protect the safety of patient volunteers.
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Bob wants to make every single bit of data collected in a clinical trial right down to the level of the anonymized patient public.
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They asked Roche for full clinical study reports, with study protocols, the reporting analysis plan, the statistical analysis plan and individual patient data so that all they could more fully determine what could be concluded from the studies.
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