Pharmaceutical Research and Manufacturers of America (PhRMA)
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Big Pharma Plays Hide-The-Ball With Data
...[E]vidence released earlier this year by Cochrane Collaboration, a London-based nonprofit, shows that a significant amount of negative data from [Tamiflu's] clinical trials were hidden from the public. The Food and Drug Administration (FDA) knew about it, but the medical community did not; the U.S. Centers for Disease Control and Prevention (CDC), which doesn’t have the same access to unpublished data as regulators, had recommended the drug without being able to see the full picture...
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Johnson & Johnson Announces Clinical Trial Data Sharing Agreement With Yale School of Medicine
Johnson & Johnson today announced that its subsidiary, Janssen Research and Development, LLC, has entered into a novel agreement with Yale School of Medicine's Open Data Access (YODA) Project that will extend its commitment to sharing clinical trials data to enhance public health and advance science and medicine.
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TransCelerate BioPharma Inc. Releases Recommended Approach For Protecting Personal Data In Clinical Study Reports
TransCelerate BioPharma Inc. ("TransCelerate") today announced that it has developed a recommended approach for protecting personal data in Clinical Study Reports (CSRs) that are shared with researchers, patients and others. The document describes an approach to apply when redacting or removing personal information from CSRs and other related clinical trial documents...
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