BioSpace

CAR-T Developers Will Need Randomized Trials as FDA Eyes Tighter Approval Requirements

For traditional approval, CAR T therapies will need to establish superiority over current standard treatments, including ...
Fierce Biotech

FDA steers cancer CAR-T developers toward randomized superiority trials in policy shift

The FDA is raising the bar for approval of CAR T-cell therapies in oncology. | The FDA is raising the bar for approval of CAR ...
JSTOR Daily

Can Randomized Controlled Trials Be Remedied?

Daedalus, Vol. 154, No. 2, The Ethics of Social Research: Perspectives from the Study of the Middle East & North Africa (Spring 2025), pp. 157-168 (12 pages) As the Middle East and North Africa (MENA) ...
Medical Device and Diagnostic Industry (MD+DI)

Computer-Aided Clinical Trials for Medical Devices: From Research to Reality

The pharmaceutical and medical device industries stand at an inflection point. After decades of reliance on traditional ...
STAT

Why Silicon Valley should demand clinical trials for its medical AI

Elemento is the director of the Englander Institute for Precision Medicine at Weill Cornell Medicine. Sternberg is the clinical director of the Englander Institute for Precision Medicine. Khozin is ...
ascopubs.org

When Less Can Be More: How the 10-Year Updated Results From the Randomized Controlled AMAROS Trial Should Affect Axillary Management in the Setting of a Positive Node

The Intersection of Lung Cancer Screening, Radiomics, and Artificial Intelligence: Can One Scan Really Predict the Future Development of Lung Cancer? The Oncology Grand Rounds series is designed to ...