MAESTrO Database » Clinical Trial
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MAESTrO Database » Clinical Trial
1M ago
20 March 2024 - The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform aimed at improving the environment for clinical trials across the European Union. ..read more
MAESTrO Database » Clinical Trial
7M ago
6 October 2023 - In a statement to the EMA, the IQWiG emphasised that single-arm studies may be sufficient for active ingredient approval in exceptional cases - but not for health technology assessments. They hinder improvements in care instead of accelerating them ..read more
MAESTrO Database » Clinical Trial
7M ago
28 September 2023 - A randomised clinical trial is frequently the preferred research design for testing new medical treatments. Randomisation helps to ensure that the participants in the treatment groups are similar in the distribution of prognostic factors. ..read more
MAESTrO Database » Clinical Trial
8M ago
4 September 2023 - Examining the clinical trials landscape in Australia is important for governance and to expand knowledge about trial activity to health professionals, the public and funders. ..read more
MAESTrO Database » Clinical Trial
9M ago
31 July 2023 - The primary objectives of a confirmatory clinical trial, namely a clinical trial conducted with the intention of changing clinical practice or obtaining regulatory approval, are typically to demonstrate and quantify the benefit of a treatment in a specific population of patients. ..read more
MAESTrO Database » Clinical Trial
9M ago
16 August 2023 - For only the fifth time, the FDA recently threatened to fine a company or clinical trial investigator for failing to post study results on a federal government database. ..read more
MAESTrO Database » Clinical Trial
10M ago
25 July 2023 - EMA has published a report from a workshop that collected insights and suggestions for possible EU level actions to improve the way clinical trials are set up and conducted in the European Union during public health emergencies. ..read more
MAESTrO Database » Clinical Trial
11M ago
20 June 2023 - Many randomised clinical trials yield statistically non-significant results. Such results are difficult to interpret within the dominant statistical framework ..read more
MAESTrO Database » Clinical Trial
11M ago
6 June 2023 - Agency requesting feedback on the draft recommendations and how they should be applied to increasingly diverse trial types and data sources ..read more
MAESTrO Database » Clinical Trial
1y ago
31 May 2023 - The US FDA on Friday released an updated draft guidance to help sponsors demonstrate efficacy for new anti-diabetic drugs and biologics for adults and children with type 1 and type 2 diabetes ..read more