The US Food and Drug Administration (FDA) has now published four draft guidances spelling out how it will consider real-world data (RWD) in regulatory decision-making, from the use of electronic ...
To inform continued development of the novel immune agent GEN-1, we compared ovarian cancer patients' end points from a neoadjuvant single-arm phase IB study with those of similar historic clinical ...
MONTREAL, QUEBEC, CANADA, May 15, 2025 /EINPresswire.com/ -- Altis Labs, Inc. (“Altis”) will present findings at ISPOR 2025 demonstrating how real-world digital ...
The FDA Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) have issued draft guidance describing sponsors can leverage external controls, such ...
VANCOUVER, BC / ACCESS Newswire / July 30, 2025 / Onco-Innovations Limited (ONCO:CA)(OTCQB:ONNVF)(Frankfurt:W1H, WKN: A3EKSZ) ("Onco" or the "Company") is pleased to announce that its wholly owned ...
New data-driven approaches change how researchers evaluate experimental therapies in clinical trials. Among these, synthetic control arms use existing datasets to provide a flexible framework for ...
Timing of Adjuvant Chemotherapy After Gastrectomy in Patients With Stage II to III Gastric Cancer: A Target Trial Emulation Study Master protocols represent transformations, enabling multiple ...
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