Determining the success or failure of a randomized trial requires looking beyond the p-value for the primary endpoint, review articles in The New England Journal of Medicine urge.
Clinical trial results should not be interpreted as on a simple binary axis of success or failure, a pair of review articles in the New England Journal of Medicine's "The Changing Face of Clinical Trials" series argues.
The "unreasonable yet widespread practice" of labeling randomized trials as positive or negative based on the p-value of the primary...
Following EU approval of the first disease-modifying treatment for Alzheimer’s disease, and with a second expected soon, the European Medicines Agency plans to update its guidance to support the design of state-of-the-art clinical trials for the disease and enhance drug development.
HHS' culling of mRNA vaccine projects under BARDA will heavily impact pandemic preparedness. Tiba Biotech was even “caught off guard” by its inclusion, because its project was neither a vaccine nor mRNA-based.
The UK drug regulator is collecting data to establish whether patients who are hospitalized for acute pancreatitis after taking a GLP-1 drug have a genetic predisposition to this side effect. If a “clear link” is found, the MHRA would consider regulatory action.
Generative artificial intelligence tools, such as ChatGPT, have “democratized” AI, and contract research organizations are wholeheartedly embracing these tools, given their focus on efficiency, says Stephen Pyke, who chairs the AI committee at the Association of Clinical Research Organizations.
