Aardvark intends to enrol 90 patients across Australia, Canada, South Korea, the UK, and the US.

The emergence of AI and biosensors offers a chance to address inefficiencies in drug development.

Regulatory alignment from the FDA and MD Anderson IRB supports resumption of enrollment in a U.S./European proof-of-concept ...

Protocol Expansion Broadens Phase 3 HERO Trial Eligibility Criteria to Include Children Ages 7+ in the United States ...

As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...

Insufficient physical activity (PA) among children has become a major global public health concern. The family environment ...

A Swiss startup called Risklick has launched artificial intelligence software for clinical trials that the company claims can reduce development time and costs by as much as 35%, according to an April ...

Dyne Therapeutics has announced a revised protocol for its ACHIEVE trial, elevating video hand opening time (vHOT) to the primary endpoint for U.S. Accelerated Approval of DYNE-101, a treatment for ...

New guidelines have been developed to help researchers ensure that their clinical trial protocols and reports are complete, high-quality and transparent. Increased consistency across these documents ...

Roughly 70 to 80% of ovarian cancer cases are diagnosed at an advanced stage, 1 where treatment options are limited and eligibility criteria for clinical trial participation become more difficult to ...

A clinical trial protocol is the foundation of clinical research, detailing objectives, study design, eligibility, safety oversight, and data analysis. Its structure ensures consistency and ...