In this regional comparison, regulatory experts at a US-based decentralized clinical trials (DCT) firm discuss their views on how the FDA’s draft DCT guideline compares with the pan-EU recommendation paper on this topic. This first segment of a two-part article dwells on the thinking behind why US and EU regulators tend to go down different paths.
Both US and EU regulators recognize the important potential benefits and value of decentralized clinical trials (DCTs) and are keen to support such studies. Their respective guidelines on DCTs - issued just five months apart - are largely similar but have some notable differences.
The US Food and Drug Administration published its draft DCT guideline in May, with stakeholder comments being accepted until 1...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance.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.
