1 Introduction

When carefully designed and analyzed, target trial emulation, i.e., the analysis of observational data through the explicit emulation of the design components of randomized controlled trials (RCT), ca...

When carefully designed and analyzed, target trial emulation, i.e., the analysis of observational data through the explicit emulation of the design components of randomized controlled trials (RCT), ca...

Academic articles from authors using large language model are creating an ecosystem of fake research that threatens human knowledge itself.

AbstractBackground. The FDA’s accelerated approval pathway expedites cancer drug approvals based on surrogate measures, while clinical benefit is assessed

In a landmark study, OpenAI researchers reveal that large language models will always produce plausible but false outputs, even with perfect data, due to fundamental statistical and computational limi...

The integrity of evidence synthesis is threatened by problematic randomised controlled trials (RCTs). These are RCTs where there are serious concerns about the trustworthiness of the data or findings....

This systematic review and meta-analysis identifies reports of systematic reviews that included retracted studies in their meta-analyses, and assesses the impact of these retracted studies on the resu...

For many important questions about influences on clinical and public health outcomes, no single study can provide a decisive answer. The perfect study—a large, diverse, well-conducted trial randomizin...

We review existing definitions and usages of validity terms and propose a single definition for each term for use in communicating inferences from Randomized Controlled trials (RCTs).

Background We assess if there are indications that results of registry-based studies comparing the effectiveness of interventions might be selectively missing depending on the statistical significance...

‘Arbitrary’ Hodgepodge of Composite Endpoints Used Across ASCVD Trials hdellabella@crf.org Thu, 02/20/2025 - 16:31 Michael O'Riordan A minority of studies used the standard three-point MACE endpoint, and many tweaked their endpoints along the…

While well-established methods for time-to-event data are available when the proportional hazards assumption holds, there is no consensus on the best inferential approach under non-proportional hazar...

This Medical News article is an interview with study author María Villalobos-Quesada, PhD, a researcher at the National eHealth Living Lab at the Leiden University Medical Centre in the Netherlands.

Not applicable.

Microbiologist Elisabeth Bik donates $200,000 to support training, travel

Clinical prediction models estimate an individual’s risk (probability) of a health related outcome to help guide patient counselling and clinical decision making. Most models provide a single point es...

Common Sense Oncology (CSO) prioritises treatments providing meaningful benefits for people with cancer. Here, we describe CSO principles aimed at improving the design, analysis, and reporting of rand...

Nearly half of clinical trial results are not made public, an exhaustive review published by the medical evidence group Cochrane has found. The new Cochrane review draws together data from 204 existin...

Randomised controlled trials (RCTs) are the cornerstone of evidence-based medicine. Unfortunately, not all RCTs are based on real data. This serious breach of research integrity compromises the reliab...

We aimed to determine whether the existing risk of bias assessment tools addressed constructs other than risk of bias or internal validity, and whether they used numerical scores to express quality, w...

Drug regulators assess and describe uncertainties regarding treatment outcomes and the benefit-risk balance of newly authorised medicines. We aimed to…

Putting contemporary clinical trials methodology into practice. Do you work in clinical trials and want to find out about the latest in the design and delivery of contemporary trials? Join us for ses...

Société Française de Pharmacologie et de Thérapeutique

The FDA released a draft guidance document detailing their interpretation of when a confirmatory clinical trial for an accelerated approval is underway.

AbstractBackground. Immortal time is a period of follow-up during which death or the study outcome cannot occur by design. Bias from immortal time has been