FDA Foreign Trials Proposed Reg Criticized As Silent On Conflict Of Interest
This article was originally published in The Pink Sheet Daily
Executive Summary
Proposed rule for accepting data from foreign clinical trials not conducted under INDs fails to require investigator conflict-of-interest disclosure to trial participants, Public Citizen’s Lurie says in commentary appearing in The Lancet. Rule also does not require sponsors to publish trial results, he notes.
You may also be interested in...
FDA Foreign Trials Proposed Rule Would Mandate "Good Clinical Practices," Not Helsinki Declaration
The proposal for ex-U.S., non-IND studies would require human subject protections in line with ICH guidances. FDA has been concerned about the most recent revisions to the Declaration of Helsinki requiring comparator trials to be used instead of placebo-controlled studies whenever possible.
NME Slowdown Shows Market Pressure On Me-Toos, Not FDA Caution – Lutter
DURHAM, N.C. - The decline in FDA's tally of new molecular entity approvals stems from fewer approvals of non-innovative products in recent years, while approvals of truly innovative products has largely held steady, according to FDA Deputy Commissioner for Policy, Planning and Preparedness Randall Lutter
Amgen Aranesp, Vectibix Setbacks Illustrate Risks Of Real World Trials
Amgen's failed Anemia of Cancer trial of Aranesp and Panitumumab Advanced Colorectal Cancer Evaluation (PACCE) trial of Vectibix may illustrate the potential pitfalls facing sponsors that conduct "real world" trials of their products