OHRP has experienced an unprecedented exodus of ethics expertise, raising concerns about its ability to effectively protect volunteers.

An illustration of a person standing on a scale

Monitoring trials in real time may help shorten the time interval between trial phases.

“For the first time, FDA regulators will be able to see what’s happening in a clinical trial, looking at endpoints in the cloud as they occur,” writes FDA commissioner.

After gene therapy for a rare form of deafness, 90% of participants in a clinical trial in China had significant improvement in hearing.

This week on "The Readout LOUD," a pancreatic cancer breakthrough and new hope for an off-the-shelf CAR-T treatment in lymphoma.

FDA officials said an internal analysis found results were not submitted for nearly 30% of studies “highly likely” to fall under mandatory reporting requirements.

New results on Pfizer's Lyme disease vaccine, how the Middle East conflict could strain drug supply chains, and more biotech news in today's Readout newsletter.

In a long-debated move, the NIH will no longer characterize basic experimental studies involving humans as clinical trials.

Even when promising clinical trials exist, and the FDA allows expanded access, rare disease patients like my granddaughter are often left out.