In its latest move on the transparency front, Glaxo endorses the U.K.-driven AllTrials campaign, which calls for releasing all clinical trial results. Announcement runs counter to PhRMA’s defense against requirements for more disclosure.
GlaxoSmithKline PLC’s backing of the U.K.-driven “AllTrials” campaign and a pledge to publish detailed clinical study reports has put it at odds with the U.S. Pharmaceutical Research and Manufacturers of America trade group, which is vociferously warning of the risks of too much transparency.
Momentum has been building globally for full reporting of trial data, including negative results, as a public safety imperative –...
Denmark is shaking up clinical trial timelines with a new process for reviewing applications for early-phase mono-national trials that is twice as fast as the standard timelines in the EU and the UK.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.
Sponsors should investigate signals of possible fraud in a manner that does not raise alarms or else evidence might disappear, UK and US regulators said.
Swiss health care products agency Swissmedic will launch a pilot in July to fast track clinical trial applications, which the agency claims will place Switzerland at the forefront compared to other European countries.
While challenges in the US present an “incredible opportunity” for Europe, there is no “doomsday” happening there, Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says.
Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
