Based on experience from earlier epidemics, EU regulators are concerned that the high number of COVID-19 trials starting in a confined geography at the peak of the coronavirus pandemic will not be able to enrol patients up to their pre-established sample size.
Senior EU regulators have expressed concern over the “unfortunate” mushrooming of stand-alone COVID-19 clinical trials and observational studies of single-agent interventions despite clear advice to the contrary.
The regulators say that in any pandemic or epidemic - as was seen in the recent Ebola outbreak in West Africa - “the window of opportunity to run adequately-powered trials...
The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.
Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.
Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.
ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.
