28 September 2023 - A randomised clinical trial is frequently the preferred research design for testing new medical treatments. Randomisation helps ...
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 ...
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31 May 2023 - The US FDA on Friday released an updated draft guidance to help sponsors demonstrate efficacy for ...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 ...
24 March 2023 - The accelerated approval pathway is commonly used for approval of oncology drugs due to the serious ...
24 March 2023 - The US FDA plans to hold at least one public meeting and release several guidances on digital ...
28 February 2023 - My toddler, Wheeler, will probably not live to adulthood. Juvenile Batten disease — he has the ...
16 February 2023 - US regulatory agency makes ‘big change’ to increase the number of participants from under-represented groups in drug ...
13 February 2023 - Since the mid 20th century, cancer drug development has been guided by the assumption that more is ...
24 January 2023 - An adaptive intervention is a set of diagnostic, preventive, therapeutic, or engagement strategies that are used in ...