A single-item instrument can capture cumulative effects of low-grade drug toxicities, informing dose selection and de-risking development programs. However, administration of those measures at baseline in treatment-naïve patients is problematic, and practical challenges and regulatory uncertainties have inhibited broad adoption by sponsors, FDA workshop participants say.
Use of a single-question, patient-reported outcome measure that assesses overall side effect impact can provide important information about the cumulative effects of drug toxicities on tolerability and adds minimal burden for clinical trial patients.
However, using those instruments comes with challenges, including administration in treatment-naïve people at baseline. Furthermore, the instruments should be used...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
Companies dealing with commercial costings or contracts with the National Health Service for early phase clinical trials or trials of advanced therapy medicinal products should soon be able to conclude their negotiations more quickly.
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the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance.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.
As the planet heats up and sea levels rise, the need to reduce carbon emissions is becoming ever more urgent. The life sciences industry is just one of many that are looking to cut the carbon it produces.
