Regulatory Affairs Professionals Society

FDA revises master protocol guidance with new section on basket trials

The US Food and Drug Administration (FDA) has revised a 2023 draft guidance on master protocols for drug and biological ...
BMJ Open

Protocol for the economic evaluation of integrated longitudinal public health interventions in a cluster randomised controlled trial setting: the healthy life trajectories ...

Introduction In 2021, globally, cardiometabolic diseases (CMDs) accounted for 35% of the 1.73 billion disability-adjusted life years (DALYs) attributed to non-communicable diseases. The Healthy Life ...
ascopubs.org

Phase II Dose-Randomized Study of Sunvozertinib in Platinum-Pretreated Non–Small Cell Lung Cancer With Epidermal Growth Factor Receptor Exon 20 Insertion Mutations (WU-KONG1B)

Impact of Human Epidermal Growth Factor Receptor 2 in Patients With Metastatic Colorectal Cancer Treated With Chemotherapy Plus Bevacizumab or Anti-EGFRs: Exploratory Analysis of Eight Randomized ...

MIRA Pharmaceuticals Submits Phase 2a Clinical Trial Protocol to FDA for Ketamir-2 in Chemotherapy-Induced Peripheral Neuropathy

Randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, and dose-response efficacy of oral Ketamir-2 at a leading U.S. cancer center MIAMI, FL / ACCESS Newswire / June 17, ...