Phase III protocols for COVID-19 vaccine candidates from Pfizer/BioNTech, Moderna, AstraZeneca and Johnson & Johnson are similar – but definitely not the same.
The unprecedented coronavirus pandemic resulted in another unprecedented event when the sponsors of the first four COVID-19 vaccine candidates to reach Phase III in the US each made public their trial’s clinical protocol document.
The normally confidential clinical protocols were released amidst rising public concern about the COVID-19 vaccine development process. A comparison of the documents shows some striking points of concurrence along with...
CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.
The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
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.
