Only a culture shift can move sponsors away from traditional monitoring to risk-based approaches, a transition being slowed by fear of change as well as confusion resulting from too many ‘flavors’ of risk-based monitoring strategies, stakeholders say; FDA tries to clarify what risk-based monitoring is, and is not.
Hoping to drive greater adoption of risk-based monitoring, the US Food and Drug Administration is trying to clear up industry misconceptions of what this approach to overseeing clinical trial quality does and does not involve.
However, it likely will take more than a clarification of definitions and terminology to overcome what pharmaceutical manufacturers, contract research organizations and study sites describe as the “fear” and...
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.
