Advanced analytical solutions provider Cytel has launched East version 6.5 to paves the way for new era of trial designs.
Cytel said since 1995, East has empowered trial sponsors of all sizes to optimize study planning and monitoring efforts, accelerate timelines, and increase their probability of success in clinical development.
The new version 6.5 of East has new modules MCPMod (for dose-finding trials using MCPMod methodology), ENRICH (for simulating a population enrichment design with a survival endpoint) and PROGRAM to optimize clinical development program using frequentist or Bayesian go/no-go rules.
The new version also includes several enhancements to the platform’s overall user interface and various new features within established modules including ESCALATE, MAMS, and PREDICT.
Cytel co-founder and a Fellow of the American Statistical Association Cyrus Mehta said” “For almost three decades, Cytel has pioneered adaptive trial methods and we have demonstrated their enormous potential to unlock better outcomes in drug development.
“The FDA’s recent launch of its Complex Innovative Designs (CID) Pilot Meeting Program is just one signal of increasing regulatory support for new design strategies that can pave the way for the next era of medical advancement. The recent release of the new FDA draft guidance for adaptive designs also represents a shift in regulatory thinking that reflects the increased industry track record and experience in these methods.
“We are proud that our continued development of East’s functionality enables our biotechnology and pharmaceutical customers to robustly and efficiently put the most promising innovative trial design methods into practice.”
The European Medicines Agency (EMA) has qualified the Multiple Comparison Procedure – Modeling (MCP-Mod) approach as an efficient statistical methodology in designing and analyzing phase 2 dose finding studies under model uncertainty.
MCPMod in East allows the design and analysis of such studies for normal, binomial and count endpoints, with several candidate models and dose selection criteria.
ENRICH helps in simulating clinical trial designs with options to adapt for population enrichment, while controlling type-1 error rate. It is also flexible in defining a zone to increase sample size and increasing enrichment zone for subgroup selection. It was developed specifically for oncology trials.
PROGRAM simulates a sequence of clinical trials within an oncology program. Simulation of dose escalation trial (3+3, mTPI, CRM, BLRM, from East ESCALATE) followed by a cohort expansion phase can be conducted on PROGRAM. It also allows users to simulate one single-arm Phase 2 trial followed by a two-arm Phase 3 trial.
Cytel software and consulting senior vice president Yannis Jemiai said: “The enhancements in East 6.5 have been developed in collaboration with our strategic consulting customers to address a number of their most pressing drug development concerns. The new ENRICH and PROGRAM modules particularly reflect the concerns of drug developers in the oncology and rare disease space where it is critical to make the best possible use of scarce data, at a program as well as at a trial level.
“Selection of the right dose for confirmatory phase 3 trials continues to be one of the biggest headaches in drug development and the MCPMod module will help our customers more easily put the EMA- qualified dose-finding methodology into practice, and use available data in the most effective manner.”