As remdesivir’s change in primary endpoint illustrates, there are many ways to measure potential treatments. A Pink Sheet analysis of 50 Phase III clinical trial protocols found numerous different approaches. Adaptive trials seems critical for speed, but a survival endpoint seems essential for durability.
The fast growth of the COVID-19 clinical pipeline has resulted in a heterogenous group of pivotal treatment trial designs and clinical endpoints, a Pink Sheet analysis of 50 Phase III clinical trial protocols found.
Seriously ill and hospitalized patients with COVID-19 make up a large majority of patients in the first wave of Phase III trials. Primary endpoint assessments have largely focused on clinical...
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.
ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.
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.
The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.
