Clinical Trials
The UK’s Health Research Authority has updated its General Data Protection Regulation “transparency wording template” with more information on how data about research participants would be handled if it is sent abroad.
The EU Clinical Trials Regulation has “so far failed to improve Europe’s competitiveness,” according to a new report commissioned by the pharmaceutical industry body EFPIA.
Oncology staff also said more work is needed before patient registries can be used as an external control in clinical trials, but they strongly encouraged continued investment.
EU regulators have recommended extending a pilot on the use of raw clinical trial data in medicines evaluations after an interim review of the initiative found that using such data improved regulatory decision-making.