A new multi-stakeholder alliance wants to improve the adoption of decentralized clinical trials that have already drawn much attention during the COVID-19 pandemic. There are plans to aggregate best practices, share evidence and information, and identify and address key barriers.
A new international alliance has been launched to address the “significant barriers” that stakeholders from across the research community continue to face in the meaningful adoption of decentralized trials.
The Decentralized Trials & Research Alliance (DTRA) was launched on 10 December with more than 50 organizations as its members,...
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
To help sponsors developing candidate mpox vaccines, the World Health Organization will soon be finalizing guidance on the preferred and minimum characteristics these products must satisfy regarding efficacy, dose regimen and other aspects to secure regulatory approval.
The WHO’s emergency committee has warned of a lack of understanding of the epidemiology of mpox, the limited availability of vaccines, and the complexities of donations and procurement.
An ongoing collaborative initiative involving global regulators assessing post-approval manufacturing changes has highlighted the need to establish a standardized platform that can facilitate the submission and regulatory evaluation of such changes.
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.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
