Clinical Trial Diversity Plans: Will US FDA Offer A Gentle Enforcement Hand?

The UK Health Research Authority’s latest three-year strategy sets ambitious targets to make research more transparent. One World Health Organization official believes the authority can go further by setting equally high standards for the timely reporting of clinical trial results.

Rexulti’s post-traumatic stress disorder sNDA tries to make up for a failed Phase III study by placing a Phase II study into a key evidentiary role, raising questions for the July 18 advisory committee meeting about assessing discordant results and post-hoc analyses.

The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.

Real-world data studies conducted by the European Medicines Agency increased by 48% according to its latest report on the topic, prompting the agency to consider how it can better integrate this type of evidence into regulatory decision-making.