FDA releases first clinical study report in data transparency pilot program – CenterWatch
The FDA recently published its first set of clinical data summary documents under the transparency pilot program. These documents include the protocol, amendments, statistical analysis plan, and portions of the clinical study report for a Phase III trial of Erleada, developed by Janssen and recently approved to treat prostate cancer. It’s believed the public release of these documents provides necessary insight into the FDA’s approval decisions, with FDA Commissioner Scott Gottlieb adding the disclosures can help sponsors address drug development challenges.
Read the full article here
Public access to clinical information on drugs and medical devices granted – Mondaq
Health Canada enacted new regulations to make drug submissions and medical device applications publicly available for non-commercial purposes. Health Canada’s new transparency regulations bring the agency up to speed with the European Medicines Agency and the U.S. Food and Drug Administration.
Eileen McMahon and her colleagues have the full story via Mondaq
New results validation messages – ClinicalTrials.gov
According to ClinicalTrials.gov, validation messages now appear when “participants” are entered into the “Type of Units Analyzed” or assigned fields in the participant flow, baseline, and outcome measures results modules. These additions are expected to reduce the amount of major issues coming from PRS review.
Keep up with ClinicalTrials.gov by visiting their online newsroom