LAUSR

About LAUSR
Donate
Contact Us

Follow us:

You are not signed in:

Sign Up!


   Articles with "arm trials" as a keyword



Use of quantitative bias analysis to evaluate single‐arm trials with real‐world data external controls

Sign Up to like & get
recommendations! Published in 2024 at "Pharmacoepidemiology and Drug Safety"

DOI: 10.1002/pds.5796

Abstract: Use of real‐world data (RWD) for external controls added to single‐arm trials (SAT) is increasingly prevalent in regulatory submissions. Due to inherent differences in the data‐generating mechanisms, biases can arise. This paper aims to illustrate… read more here.

Keywords: external controls; use quantitative; single arm; real world ... See more keywords

Approaches for testing noninferiority in two-arm trials for risk ratio and odds ratio

Sign Up to like & get
recommendations! Published in 2019 at "Journal of Biopharmaceutical Statistics"

DOI: 10.1080/10543406.2019.1572616

Abstract: ABSTRACT For an existing established drug regimen, active control trials are defacto standard due to ethical reason as well as for clinical equipoise. However, when superiority claim of a new drug against the active control… read more here.

Keywords: two arm; arm trials; odds ratio; noninferiority ... See more keywords

Improvement of assessment in surrogate endpoint and safety outcome of single-arm trials for anticancer drugs

Sign Up to like & get
recommendations! Published in 2024 at "Expert Review of Clinical Pharmacology"

DOI: 10.1080/17512433.2024.2344669

Abstract: ABSTRACT Introduction Single-arm trials (SATs) and surrogate endpoints were adopted as pivotal evidence for accelerated approval of anticancer drugs for more than 30 years. However, concerns regarding clinical evidence quality in trials, particularly in the SATs… read more here.

Keywords: single arm; outcome; arm trials; surrogate endpoint ... See more keywords
Photo from wikipedia

New approaches for testing non-inferiority for three-arm trials with Poisson distributed outcomes.

Sign Up to like & get
recommendations! Published in 2020 at "Biostatistics"

DOI: 10.1093/biostatistics/kxaa014

Abstract: With the availability of limited resources, innovation for improved statistical method for the design and analysis of randomized controlled trials (RCTs) is of paramount importance for newer and better treatment discovery for any therapeutic area.… read more here.

Keywords: three arm; non inferiority; treatment; arm trials ... See more keywords