More than 5% of participants in J&J’s vaccine trial chose to be unblinded because they were eligible to receive a vaccine that had already gained a US FDA emergency use authorization.
Johnson & Johnson reported significant losses of participants in its coronavirus vaccine clinical trials because they could receive a product that already had received emergency use authorization, a problem that may grow as vaccine development continues.
In briefing documents for the 26 February Vaccines and Related Biological Products Advisory Committee meeting on the vaccine candidate...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
Contract research organizations (CROs) in India must gear up to comply with new registration requirements coming into effect in April 2025 that aim to enhance the quality and integrity of clinical trials, as well as of any bioavailability and bioequivalence studies conducted by them.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
Contract research organizations (CROs) in India must gear up to comply with new registration requirements coming into effect in April 2025 that aim to enhance the quality and integrity of clinical trials, as well as of any bioavailability and bioequivalence studies conducted by them.
The agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.
