Oncology Center of Excellence program will use the Evidence Accelerator to examine COVID’s impact on treatment initiation, regimen selection and therapeutic utilization, potential adverse sequalae, and outcomes.
The US Food & Drug Administration’s COVID-19 Evidence Accelerator is evaluating the effects of COVID-19 infection on cancer patients via a new Oncology Center of Excellence initiative dubbed “Project Post COVIDity.”
The initial focus will be on understanding how COVID infection impacts cancer patients “on active treatment and associated immunotherapy,” the...
A project to advance effective treatments for long COVID was framed as a high priority for HHS Secretary Robert F. Kennedy Jr.
Sponsors should systematically incorporate real-world evidence generation in all development programs, advises an epidemiology-forward “blueprint” Aetion executives developed.
Acknowledging the risks and limitations of factorial designs, draft guidance outlines how sponsors might employ external data, such as registries or patient-level real-world data, for combination cancer therapies.
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.
Despite strong online visibility, Europe's RADIAL trial struggled to convert digital interest from potential study participants into real-world recruitment in its fully decentralized arm.
Multiple Korean ministries, biopharma companies, and other officials convened at a bio innovation roundtable to discuss strategies to emerge as a global biopharma powerhouse.
Despite being a longstanding requirement under EU and international regulations, the Danish Medicines Agency says its good clinical practice inspectors frequently encounter cases where sponsor-appointed clinical trial monitors are denied direct access to patient records.
