Clinical trials in context
This article was originally published in The Tan Sheet
Executive Summary
Randomized clinical trials presented in five major medical journals in 2001 show "no evidence of progress" in discussing results "within the context of, or with reference to, up-to-date systematic reviews of relevant evidence from other controlled trials" when compared with studies published in 1997, Mike Clarke, et al., UK Cochrane Centre, conclude in June 5 JAMA. In an issue devoted to peer review, the authors looked at discussion sections of 30 studies published in JAMA, Annals of Internal Medicine, British Medical Journal, The Lancet or NEJM...
You may also be interested in...
Roche/Genentech Keeps Commitment To External Cancer Innovation
Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.
US FDA Eases Changes For Certain Sterile Injectable Container Closure Materials
To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.
Unprecedented To Lawful: Regulatory Precedent Needed For Cannabinoids’ Use In Supplements?
“This is truly uncharted territory because we’ve never had this situation,” says CHPA regulatory VP David Spangle. Asking Congress instead to instruct FDA to first determine a safe daily limit would be a threatening precedent for the supplement market, says CRN CEO Steve Mister. “That really turns DSHEA on its head.”
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: