Software Demo: Powerful New Capabilities in StatXact 11 and LogXact 11
⇒ Compare proportions using Bayesian confidence intervals
⇒ Seamlessly incorporate R functions into exact p-value computation analyses
⇒ Correct for bias in logistic and Poisson regression analyses
⇒ Fit negative binomial regression models for count data with extra variability
⇒ Use new options to improve the performance of exact tests
Examining Risk and Outcomes in Outsourcing:
A Case Study to Help Consider Your Options
⇒ A coherent way to categorize risk in the context of pharmaceutical development
⇒ How outsourcing can effect risk, cost & outcome in both good and bad ways
⇒ Why you need to pay closer attention to your biostats & data management provider
⇒ How to use outsourcing to reduce risk
Next Generation Feasibility Studies with EnForeSys Predictive Software:
Better Planning through Simulation
⇒ Why trials typically fail to meet predicted enrollment rates: What are we missing?
⇒ The benefit of expressing enrollment cycle times in probabilistic terms
⇒ How to use Monte Carlo-based simulation to create a more realistic recruitment plan
⇒ Generating and aligning input parameters from stakeholders.
Of interest to any development leader or clinical professional interested in understanding why trials fall short on recruitment goals
Statistical and Operational Challenges of VALOR: Adaptive Phase 3 Oncology Trial
The recently completed VALOR trial comparing vosaroxin to cytarabine in acute myeloid leukemia (ASH 2014) comprises the largest body of evidence for AML from a randomized Phase 3 trial. This adaptive event-driven design featured an unblinded DSMB interim analysis potentially allowing for early efficacy stopping, early futility stopping, unblinded sample size re-estimation, or continuation as planned.
We present top-line results and discuss the operational, regulatory and statistical challenges that were faced along the way. To our knowledge this is the first Phase 3 confirmatory oncology trial in which unblinded sample size re-estimation was implemented.
Need to Reinvent the Clinical Trial?
Innovate Collaborate & Integrate
⇒ Approaches proven to reduce time and cost without compromising quality in clinical development
⇒ Learn specific techniques enabling drug and device developers to reap the full potential of clinical programs
⇒ Make a compelling business case for new initiatives to key stakeholders: financial, medical, statistical and logistical