May 17, 2017 7:22:51 AM
This new case study shares how Cytel supported a specialist biopharmaceutical company from Phase 2 trial design through to an FDA submission for their lead product candidate. We assembled an expert multidisclipinary team of data coding specialists, biostatisticians, statistical programmers and medical writers to support a number of the studies in the ongoing program, including pivotal Phase 2b...
Topics: biostatistics, Case Study, Statistical Programming, CDISC
Mar 24, 2017 9:27:00 AM
Robust go/no-go (GNG) decision-making is essential for effectively managing risk across a clinical portfolio. In early phase development, it is particularly important to have the correct tools in place to terminate ineffective compounds quickly, while accelerating promising ones through the process.
Topics: biostatistics, custom software, go-no-go, Bayesian, Bayesian Methods, Case Study
Nov 18, 2016 10:04:00 AM
Challenge
Our client had the following key questions which they wanted our pharmacometrics group to address for an upcoming phase 2 trial of their ulcerative colitis compound .
1) Can knowledge from pre-clinical and Phase 1 data inform on the optimal range of doses for an upcoming Phase 2 dose-ranging study?
2) How may the dose response observed in PD markers in Phase 1 healthy volunteers...
Topics: biostatistics, Cytel Strategic Consulting, pharmacometrics, PK/PD, Case Study
Oct 22, 2015 2:28:53 PM
Topics: Case Study, Pediatric, MCP-Mod
Sep 15, 2015 3:56:42 PM
Topics: Bayesian Methods, Cytel Consulting, Case Study, Adaptive Clinical Trials
Sep 4, 2015 10:30:00 AM
Our Client's Challenge:
Can knowledge of the relationship between biomarkers and clinical endpoints help us to optimize an early development program and improve the probability of selecting the right dose in Phase 3?
Our client approached us hoping to expedite dose-finding with biomarkers in Phase 1b, and to design an optimal Phase 2b clinical endpoint trial to maximize probability of correct...
Topics: Cytel Consulting, Early Phase Trials, Clinical Development Strategy, Proof-of-Concept, Case Study, Biomarkers, Simulations
Jan 22, 2015 9:00:00 AM
The Journal of the American Medical Association recently published an article entitled ‘The Anatomy of Medical Research: US and International Comparisons.’ The stated objective of the study was to “quantify total public and private investment and personnel (economic inputs) and to evaluate resulting patents, publications, drug and device approvals, and value created (economic outputs)“ [1]
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Topics: Dose-Finding, Early Phase Trials, Proof-of-Concept, Case Study