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AstraZeneca is catching the clinical trial transparency wave, creating a new scientific review board to evaluate requests for the company’s data. Read More
Possible conflicts of interest, such as industry payments to a clinical investigator for running trials, should be disclosed to trial participants during the informed consent process, a group of trial experts says. Read More
Consumer advocacy watchdog Public Citizen is calling for an in-depth investigation of alleged human subject protection violations at the University of Minnesota between 2011 and 2014 and revocation of the university’s human subjects research credentials. Read More
The UK’s Medicines and Healthcare products Regulatory Authority approved approximately one-quarter of Phase I and one-third of Phase II-IV clinical trials on first review between April 2014 and March of 2015. Read More
The UK BioIndustry Association and EuropaBio are calling for European regulators to drop plans to release Phase I clinical trial reports, saying the information they contain is commercially sensitive. Read More
The FDA should make unredacted results of clinical trial site inspections more readily available to the public and to readers and editors of scientific journals, to ensure transparency about tainted studies and potentially bogus drugs, an article in the February JAMA Internal Medicine says. Read More
The UK BioIndustry Association and EuropaBio are calling on European regulators to defer plans to report Phase I clinical trial reports, saying the information they contain is commercially sensitive. Read More
The European Medicines Agency is defending its decision to redact certain clinical study reports for AbbVie’s Humira before releasing them to a researcher, setting up a test case for the EU’s new trial transparency policy. Read More
Sponsors of clinical trials in India must begin reporting all deaths that occur “in clinical trials,” under final guidance issued March 3 by the Central Drugs Standard Control Organization. Read More
A German regulator says European Medicines Agency plans for implementing its clinical trials database let drugmakers withhold too much information, such as study protocols, methods and trial results, under the exemption for commercially confidential information. Read More