Nov 9, 2016 9:03:11 AM
Adaptive sample size re-estimation designs are an important part of the statistician's toolkit. In this first in a series of East Insight videos, Cytel Statistician Charles Liu walks us through the creation of an adaptive sample size re-estimation design in East with a 5 minute demo. Watch the video and download the accompanying slidedeck to recreate the steps.
Topics: East, sample size re-estimation, adaptive sample size re-estimation, adaptive trials
Sep 7, 2016 8:00:00 AM
In the 2010 draft FDA ‘Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics', the agency makes an important distinction between ‘well understood’ and ‘less well understood’ adaptive designs.
‘Well understood” adaptive designs may include such approaches as adaptation of eligibility criteria, adaptation for stopping early and adaptations to maintain study power...
Topics: sample size re-estimation, Clinical Research Services, type 1 error, Software Simulations, patient enrollment, adaptive designs, adaptive trials, DMC
Aug 26, 2016 11:30:00 AM
At the recent JSM in Chicago, Cytel’s Sam Hsaio and Lingyun Liu alongside Genentech's Romeo Maciuca, presented a framework for inference in adaptive bioequivalence trials with unblinded sample size re-estimation.
The Problem
In bioequivalence trials where the variance is often unknown, and the sample size small, using boundaries derived under the assumption of a normally distributed test...
Topics: sample size re-estimation, biostatistics, Lingyun Liu, adaptive trials, JSM, Sam Hsaio
Jul 18, 2016 8:00:00 AM
In order for adaptive designs to reach their potential, it’s critical that knowledge is effectively dissemirnated within the medical research community – in particular detailed information about the operating and statistical characteristics of specific designs and insights as to their benefits and limitations.
Cytel recently announced the publication of an important article in the New England...
Topics: sample size re-estimation, Phase 3, Adaptive Clinical Trials, phase 2, biostatistics, adaptive designs, Seamless designs
Apr 7, 2016 10:30:00 AM
Francois Beckers, Global Head of Biostatistics & Epidemiology at Merck KGaA joined us at the East User Group Meeting in March and presented case studies of Merck KGaA’s experiences with Blinded Sample Size Re-estimation in early phase studies, more specifically in the context of biosimilar studies.
Topics: sample size re-estimation, Cytel Consulting, Cytel Videos, Phase 1, Early Phase Trials
Sep 18, 2014 10:44:00 AM
When designing clinical trials, many trial designers are advised to keep the trial simple. Prima facie, the keep it simple principle seems like sound advice. There are various logistical uncertainties that arise when implementing a clinical trial, and the more simple a trial – so conventional wisdom says – the easier it is to respond to these uncertainties.
According to Zoran Antonijevic, a...
Topics: Oncology, Promising Zone, sample size re-estimation, Enrichment, Cytel Consulting, Efficacy, Interim Analyses, forecasting, optimization, Program and Portfolio Optimization, R&D, Adaptive Clinical Trials
May 13, 2014 8:31:00 AM
The VALOR trial recently applied a promising zone design to a Phase 3 evaluation of Vosaroxin, a candidate for the treatment of relapsed/refractory acute myeloid leukemia. CMO Dr. Adam Craig reports that there were intial anxieties about financing a trial that required 800 patients. However, a promising interim look raised investors' confidence in the treatment's success, leading to a...
Topics: Oncology, Promising Zone, sample size re-estimation, Movers & Shapers, Adaptive Clinical Trials
May 5, 2014 10:21:00 PM
A new JAMA study on discontinued randomized trials in Switzerland, Germany and Canada, reports that poor recruitment accounts for 101 out of 253 trials that were eventually discontinued (or about 10% of the 1017 trials which participated in the study). When restricted to industry-sponsored trials with non-healthy volunteers, poor recruitment accounted for the discontinuation of 40 trials out...
Topics: Nitin Patel, East, East 6.3, Access to Slides PDF, Recruitment, East Recruit, Sample Size, Promising Zone, sample size re-estimation, Adaptive Clinical Trials