Design and Statistical Innovations in a Platform Trial for ALS.
Sign Up to like & getrecommendations! Published in 2023 at "Annals of neurology"
DOI: 10.1002/ana.26714
Abstract: Platform trials allow efficient evaluation of multiple interventions for a specific disease. The HEALEY ALS Platform Trial is testing multiple investigational products in parallel and sequentially in persons with ALS with the goal of rapidly… read more here.
Keywords: disease; platform trial; design statistical; trial ... See more keywords
PMED: Optimal Bayesian Platform Trial Design with Multiple Endpoints
Sign Up to like & getrecommendations! Published in 2022 at "Journal of Biopharmaceutical Statistics"
DOI: 10.1080/10543406.2022.2080692
Abstract: ABSTRACT In oncology drug development, indication selection and optimal dose identification are the primary objectives for the early phase of clinical trials and could significantly impact the probability of success. Master protocols, e.g., basket trial,… read more here.
Keywords: optimal bayesian; platform trial; trial; design ... See more keywords
A bayesian platform trial design to simultaneously evaluate multiple drugs in multiple indications with mixed endpoints.
Sign Up to like & getrecommendations! Published in 2022 at "Biometrics"
DOI: 10.1111/biom.13694
Abstract: In the era of targeted therapies and immunotherapies, the traditional drug development paradigm of testing one drug at a time in one indication has become increasingly inefficient. Motivated by a real-world application, we propose a… read more here.
Keywords: bayesian platform; mixed endpoints; platform trial; trial ... See more keywords
Phase I INSIGHT platform trial: Advanced safety and efficacy data from stratum D evaluating feasibility and safety of eftilagimod alpha (soluble LAG-3 protein) combined with avelumab in advanced solid tumors.
Sign Up to like & getrecommendations! Published in 2021 at "Journal of Clinical Oncology"
DOI: 10.1200/jco.2021.39.15_suppl.2518
Abstract: 2518 Background: Stratum D of the INSIGHT platform trial evaluates s.c. eftilagimod alpha (efti, IMP321) combined with avelumab in advanced solid tumors. Efti is an MHC class II agonist which activates antigen-presenting cells followed by… read more here.
Keywords: grade grade; grade; platform trial; coh ... See more keywords
Pharmacometrics of high-dose ivermectin in early COVID-19 from an open label, randomized, controlled adaptive platform trial (PLATCOV)
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DOI: 10.7554/elife.83201
Abstract: Background: There is no generally accepted methodology for in vivo assessment of antiviral activity in SARS-CoV-2 infections. Ivermectin has been recommended widely as a treatment of COVID-19, but whether it has clinically significant antiviral activity… read more here.
Keywords: platform trial; trial; covid; high dose ... See more keywords