Remove tag anxiety-disorders
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Blue Note leukaemia DTx gets FDA breakthrough tag

pharmaphorum

The DTx, called BNT200, is described as a first-of-its-kind DTx to treat anxiety and depression in adults with acute myeloid leukaemia (AML) who are hospitalised for a regimen of high-intensity induction chemotherapy. The post Blue Note leukaemia DTx gets FDA breakthrough tag appeared first on.

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Grand Rounds Ethics and Regulatory Series October 14, 2022: Responding (or Not) to Signals of Potential Clinical Significance in Pragmatic Clinical Trials (Joseph Ali, JD; Tanya Matthews, PhD; Leslie J. Crofford, MD)

Rethinking Clinical Trials

substance use, depression, anxiety, suicidality). Trials are getting larger and collecting greater volumes of clinical data than ever before, often as part of Common Data Elements (CDEs). These data increasingly include info that might signal physical, mental health or behavioral health risks to patient-subjects (e.g. pctGR, @Collaboratory1.