In a phase III trial, sample size calculation is the most critical component of the study design. In clinical trials with continuous or binary endpoints, responses of patients are typically observed immediately or shortly after treatment. Phase III trials often collect such time-to-event data to ...
The latest update is out from Clene ( ($CLNN) ). Clene Inc. unveiled the preliminary design for RESTORE-ALS, a significant Phase 3 clinical trial of their CNM-Au8 3...
Clinical Trial Design:临床试验设计 热度: 页数:68 TAXUS Moderate Release Data Clinical Trial Results红豆杉中释放数据的临床试验的的结果 热度: 页数:10 methodological issues for designing and conducting a multicenter, international clinical trial in acute stroke experience from artss-2 trial:为开展多...
Design of a phase III multicenter trial to evaluate the efficacy of the RTS,S/AS01 malaria vaccine in children across diverse transmission settings in PK Lomas - 《South African Journal of Economics》 被引量: 1发表: 2010年 Immune escape and immune camouflage may reduce the efficacy of RTS,S...
In our designs, the WHO ordinal scale is used to classify COVID-19 patients into different stages based on their clinical status, but it is difficult to design a trial based on every stage. As a result, we combined groups with similar standard treatment options together. Based on the ordina...
Concerns have been recognized about the operating characteristics of the standard 3 + 3 dose-escalation design. Various innovative phase 1 trial designs have been proposed to address the issues and new challenges posed by molecularly targeted agents. However, in spite of these proposals, the ...
Results The proposed seamless phase II/III TB trial designs are shown to greatly reduce sample size requirements and trial duration compared to conducting ... DJ Bratton,PP Phillips,MK Parmar - 《Bmc Medical Research Methodology》 被引量: 58发表: 2013年 Seamless Phase I-II Trial Design for As...
In conclusion, in the SURMOUNT-3 trial, tirzepatide demonstrated clinically meaningful additional body weight reductions in adults with overweight or obesity following initial weight loss with intensive lifestyle intervention. Methods Study design and participants ...
3 C. Faivre-Finn, M. Snee, L. Ashcroft,et al. Concurrent once-daily versus twice-daily chemoradiotherapy in patients with limited-stage small-cell lung cancer (CONVERT): an open-label, phase 3, randomised, superiority trial Lancet Oncol, 18 (2017), pp. 1116-1125 ...
"We are pleased to have reached an agreement with the FDA on key elements of the Phase 3b trial design that provides a potential path forward towards obtaining regulatory approval," said Chaim Lebovits, President and Chief Executive...