Nearly 40% of registry patients would have been excluded from phase 3 randomized controlled trials, with exclusion criteria distributed unevenly across drug classes.
Federal prosecutors allege that a Florida physician and research staff fabricated clinical trial records that were submitted into database systems used to evaluate investigational drugs.
Ten-year observational data showed lower disease activity and functional disability coinciding with broader use of biologic and targeted synthetic therapies.
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A systematic review found Janus kinase inhibitor monotherapy improved outcomes vs methotrexate or placebo, but direct comparisons with combination therapy were limited.