The US government may require companies running clinical trials to post their informed consent forms publicly, under rules proposed by the Department of Health and Human Services (HHS).
The new EU clinical trial regulation will overhaul the sector according to SynteractHCR, but are CROs prepared for the extra resources and tighter deadlines it will produce?
A five-month legal battle over the duties of trial sponsors to publish results has ended with a judge ruling the UK regulator acted unlawfully and sponsors will not be required to publicly register UK Phase I adult trials which began before September...
Investor backing puts transparency on the pharma agenda says SenseAboutScience, even though none of the funds pledging support for Alltrials have committed to pull investment from drug firms that disagree.
With a House floor vote looming this week, legislators will decide on a revised bill that has decreased the amount of funding that will go to the NIH from the original bill, and removed a section that would have required NIH grant recipients to share...
Trade secrets proposals supported by the European Parliament’s legal affairs committee could allow drugmakers to withhold trial results and drug safety data says Health Action International.
Drug, vaccine and medical device developers should publish all trial results according to the WHO, which says anything less skews R&D priorities and public healthcare investment.
Despite legal reporting requirements, the vast majority of results from clinical trials are not reported on ClinicalTrials.gov within a year of their ending, according to a new study from the New England Journal of Medicine.
The European CRO (contract research organization) Federation is calling on the EMA (European Medicines Agency) to not allow for the “unrestricted publication of inspection reports” as only “findings that are of relevance to the public should be made publicly...
