Where medical statistics meets artificial intelligence

28 September 2023 - Challenges at the interface of medical statistics and AI are population inference versus prediction, generalisability, reproducibility and ...

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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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Stakeholders want more clarity on FDA's statistical approach to assessing bioequivalence

7 February 2023 - Commenters on the US FDA draft guidance outlining principles for in vivo or in vitro bioequivalence ...

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Statistical approaches to establishing bioequivalence

2 December 2022 - Requirements for submitting bioavailability and bioequivalence data in investigational new drugs, new drug applications, abbreviated new drug ...

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Regression models for ordinal outcomes

4 August 2022 - Ordinal logistic regression models are tailored for the analysis of ordinal outcomes. ...

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Patient reported outcome measures in clinical research

 2 August 2022 - Health conditions may cause patients to feel ill and have impaired functioning in their daily lives. Thus, ...

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Testing for differences in survival when treatment effects are persistent, decaying, or delayed

7 July 2022 - A statistical test for the presence of treatment effects on survival will be based on a null ...

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Instrumental variables and heterogeneous treatment effects

22 March 2022 - A randomised clinical trial can be used to estimate the average treatment effect for a population.  ...

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Collider bias

14 March 2022 - Bias is a systematic, non-random error in the estimation of a treatment effect or the effect of ...

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Assessing unexpected circumstances that lead to modifications in clinical trial design, conduct, or analysis application of the CONSERVE Reporting Guideline

1 March 2022 - In the COVID-19 Dexamethasone (CoDEX) randomised clinical trial, which studied a sample of critically ill patients with ...

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Heterogeneity of treatment effect; estimating how the effects of interventions vary across individuals

14 December 2021 -  ...

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Use of confidence intervals in interpreting non-statistically significant results

23 November 2021 - The goal of much of medical research is to determine which of 2 or more therapeutic approaches ...

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Estimands, estimators and estimates

23 August 2021 - The primary goal of most randomised clinical trials is to draw conclusions about the effect of a ...

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Immortal time bias in observational studies

16 February 2021 - Observational studies are commonly used to evaluate the association between a risk factor or “exposure” and the ...

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Even before year end, 2020's new drug approvals match FDA's 2019 stats

7 December 2020 - The US FDA has kept its new drug approvals for 2020 on track to match or ...

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