A solid understanding of statistical concepts by clinicians improves the comprehension and the resulting quality of clinical trials. This manuscript outlines common statistical concerns in …

Statistics is a key tool linking the multiplicity of potential observations of every client with the more abstract concepts of clinical entities, natural histories, clinical response and risks. These more …

This paper is a practical guide to the essentials of statistical analysis and reporting of randomized clinical trials (RCTs). It is the first in a series of 4 educational papers on statistical issues for …

Jun 1, 2021 · This article explores basic statistical concepts of clinical trial design and diagnostic testing, or how one starts with a question, formulates it into a hypothesis on which a clinical …

Explore key statistical principles in clinical trials, from study design to data interpretation, ensuring reliable and valid research outcomes.

Assuming that a clinical trial will produce data that could reveal differences in effects between two or more interventions, statistical analyses are used to determine whether such differences are …

We’ll cover some methods for using both quantitative and qualitative data to interpret clinical trial results in Part IV of this series. Qualitative data isn’t always subject to objective evaluation and …

These include multiplicity of data, covariate adjustment, subgroup analysis, assessing individual benefits and risk, analysis by intention to treat and alternatives, the interpretation of surprises …

This JAMA Guide to Statistics and Methods article discusses clinical trials using factorial designs in which participants receive several randomized interventions simultaneously to allow efficient …

Jun 1, 2021 · This article describes the role of statistics in clinical trials, covering study design, directionality, variables, randomization and blinding, error reduction, probability and ethics as …

Mar 19, 2024 · Learn how to read study results in records posted on ClinicalTrials.gov. Results include information about the study’s participant flow, baseline characteristics, outcome …

Feb 27, 2025 · The “Guideline for the Content of Statistical Analysis Plans in Clinical Trials,” published in 2017 and referred to here as the 2017 SAP guidelines, outlines a minimum set of …

The purpose of this series is threefold: (1) to provide an overview of common epidemiological and statistical terms and concepts that can be useful to the practitioner and clinical researcher, (2) …

Jun 1, 2021 · This article explores basic statistical concepts of clinical trial design and diagnostic testing, or how one starts with a question, formulates it into a hypothesis on which a clinical …

The hierarchy of evidence is a systematic framework used to assess and rank the quality of evidence in medical research and healthcare decision-making. This approach is vital for …

Mar 21, 2025 · This needs to be addressed for future data sharing, interoperability, and for comparing clinical trial outcomes across the globe. Companies on the forefront of innovation …

Mar 12, 2025 · Background The planning and analysis of multi-regional clinical trials (MRCTs) has increased in the pharmaceutical industry to facilitate global research and development. The …

4 days ago · We thank the National Cancer Institute for access to data collected by the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. Supplementary Material Disclosure …

Mar 6, 2025 · The goal of this perspective is to discuss why translation in this rapidly expanding field has stalled and highlight the importance of combining emerging big-data approaches with …

Over the last 5 years, there have been more than 140 new drug approvals in the field of Oncology alone, all based on newly published clinical trials. These approvals have led to an ongoing …

Our approach enhances the understanding of global variation in rotavirus vaccine performance and can be used to inform predictions of the potential impact of rotavirus vaccines for countries …

Feb 25, 2025 · Background Methods of integrating qualitative data across diverse studies and within multi-site research consortia are less developed than those for integrating quantitative …

Mar 1, 2025 · Ongoing and future clinical trials will enhance the understanding of zanidatamab’s efficacy and safety across a broader range of HER2-positive cancer types. If long-term studies …

While the number of clinical trials performed yearly is increasing, the application of these results to individual patients is quite difficult. This article reviews key portions of the process of applying …

6 days ago · Antiphospholipid syndrome (APS) is an autoimmune disorder associated with thrombotic events and adverse obstetric outcomes, particularly in its obstetric form (OAPS). …