JD Supra

Real-World Evidence: Non-Interventional Studies in Support of Substantial Evidence of Effectiveness

The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA ...
JD Supra

FDA advises on RWE non-interventional study use as evidence of effectiveness or safety

Today, the U.S. Food and Drug Administration (FDA) published the draft guidance “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products,” which ...
Business Wire

Thrive Earlier Detection Announces Groundbreaking Clinical Data from the First Ever Interventional Study of a Blood-Based Test to Screen and Identify Multiple Types of Cancer

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Thrive Earlier Detection Corp., a company dedicated to extending and saving lives by incorporating earlier cancer detection into routine medical care, together with ...
Business Wire

GRAIL to Present Final Multi-cancer Early Detection Data From the Interventional PATHFINDER Study at ESMO Congress 2022

MENLO PARK, Calif.--(BUSINESS WIRE)--GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, today announced final results from the interventional PATHFINDER ...
News Medical

Insight into the Different Clinical Trial Study Designs

Clinical trials are well-controlled and designed experiments that aim to prove that an Investigational Medicinal Product (IMP) is effective. Clinical trial data is submitted to the national health ...
BMJ Global Health

School-based behaviour change intervention to reduce ultra-processed food consumption among adolescents: evidence from a cluster-randomised controlled trial in India

Background The global surge in ultra-processed food (UPF) consumption is a major public health challenge, particularly among adolescents. UPFs, characterised by high energy density, added sugars, fats ...