This second segment of a two-part article on a regional comparison of EU and US approaches to decentralized clinical trials highlights the differences between the two regions relating to the more practical aspects of setting up and running such studies.
EU and US regulators are closely aligned in their efforts to support modernization in clinical research and their recent recommendations on decentralized clinical trials (DCT) are a testament to this fact. There are, however, some differences between the two regulators when it comes to their advice on running DCTs.
EU regulators offered their harmonized perspective on the use of decentralized elements in clinical trials in a final recommendation paper...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance.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.
