Accelerating stakeholder collaboration to enhance the clinical trials environment in the EU

20 March 2024 - The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform aimed at ...

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The use of historical controls in clinical trials

28 September 2023 - A randomised clinical trial is frequently the preferred research design for testing new medical treatments. Randomisation helps ...

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The changing landscape of clinical trials in Australia

4 September 2023 - Examining the clinical trials landscape in Australia is important for governance and to expand knowledge about trial ...

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Futility in clinical trials

31 July 2023 - The primary objectives of a confirmatory clinical trial, namely a clinical trial conducted with the intention of ...

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In a rare move, FDA threatens to fine a company for failing to report clinical trial results

16 August 2023 - For only the fifth time, the FDA recently threatened to fine a company or clinical trial ...

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Paving the way towards coordinated clinical trials in public health emergencies in the EU

25 July 2023 - EMA has published a report from a workshop that collected insights and suggestions for possible EU level ...

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Evidence of lack of treatment efficacy derived from statistically non-significant results of randomised clinical trials

20 June 2023 - Many randomised clinical trials yield statistically non-significant results. Such results are difficult to interpret within the dominant ...

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FDA announces additional steps to modernise clinical trials

6 June 2023 - Agency requesting feedback on the draft recommendations and how they should be applied to increasingly diverse trial ...

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FDA considers new efficacy endpoint for diabetes drugs

31 May 2023 - The US FDA on Friday released an updated draft guidance to help sponsors demonstrate efficacy for ...

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The FDA is ignoring patients in clinical trials

28 May 2023 - Imagine having two daughters who both have a rare disease and watching them struggle — to ...

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Adjusting for covariates in randomized clinical trials for drugs and biological products

26 May 2023 - This final guidance describes FDA’s current recommendations regarding adjusting for covariates in the statistical analysis of randomised ...

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The role of disclosures: helping to understand oncology clinical trial endpoints

18 May 2023 - FDA researchers wanted to see whether consumers understand oncology endpoints in DTC television ads, and whether disclosures ...

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EMA addresses considerations for single-arm trials

21 April 2023 - A new reflection paper from the EMA offers some suggestions to sponsors on how to design ...

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Clinical trial considerations to support accelerated approval of oncology therapeutics

24 March 2023 - The accelerated approval pathway is commonly used for approval of oncology drugs due to the serious ...

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FDA outlines plan for digital health technologies for clinical trials

24 March 2023 - The US FDA plans to hold at least one public meeting and release several guidances on digital ...

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