14 September 2024 - Pragmatic and cluster RCTs offer opportunities for advancing research but present ethical challenges. ...
3 June 2024 - Traditional randomised clinical trials have long been a key tool underpinning drug and device development. ...
20 March 2024 - The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform aimed at ...
6 October 2023 - In a statement to the EMA, the IQWiG emphasised that single-arm studies may be sufficient for ...
28 September 2023 - A randomised clinical trial is frequently the preferred research design for testing new medical treatments. Randomisation helps ...
4 September 2023 - Examining the clinical trials landscape in Australia is important for governance and to expand knowledge about trial ...
31 July 2023 - The primary objectives of a confirmatory clinical trial, namely a clinical trial conducted with the intention of ...
16 August 2023 - For only the fifth time, the FDA recently threatened to fine a company or clinical trial ...
25 July 2023 - EMA has published a report from a workshop that collected insights and suggestions for possible EU level ...
20 June 2023 - Many randomised clinical trials yield statistically non-significant results. Such results are difficult to interpret within the dominant ...
6 June 2023 - Agency requesting feedback on the draft recommendations and how they should be applied to increasingly diverse trial ...
31 May 2023 - The US FDA on Friday released an updated draft guidance to help sponsors demonstrate efficacy for ...
28 May 2023 - Imagine having two daughters who both have a rare disease and watching them struggle — to ...
26 May 2023 - This final guidance describes FDA’s current recommendations regarding adjusting for covariates in the statistical analysis of randomised ...
18 May 2023 - FDA researchers wanted to see whether consumers understand oncology endpoints in DTC television ads, and whether disclosures ...