Learning & Resource Center: On-Demand Videos

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Expert Webinars and Presentations

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Software Demo: Powerful New Capabilities in StatXact 11 and LogXact 11

Webinar hosted by Chris Corcoran

⇒ 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

Presentation given by Steve Herbert, Cytel Senior Vice President

⇒ 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

Webinar hosted by Chris Conklin & Charles Liu

⇒ 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

Jennifer Smith, Executive Director Biometrics. Sunesis Pharmaceuticals, and Cyrus Mehta, President & Co-Founder, Cytel

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

Webinar hosted by Laurie Halloran & Irving Dark

⇒ 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

East 6.3 PREDICT
A New Module for Predicting the Course of a Trial

Webinar hosted by Cyrus Mehta

From the Clinic to the CFO
Adaptive Trials & Financial Decision Making

Webinar hosted by Nitin Patel & Frank David

Dose Escalation with East 6.3 ESCALATE
Phase I Dose Escalation Study Design with East ESCALATE

Webinar hosted by Pantelis Vlachos

⇒ Introduction to the methods considered in East 6.3 ESCALATE
⇒ Demo of East 6.3 ESCALATE
⇒ Open Q&A Session

Nonparametric Inference for Correlated Data :
Solving Difficult Research Questions with StatXact

Webinar hosted by Chris Corcoran

When Outsourcing Stops Making Sense:

Webinar hosted by Steve Herbert

Planning and Implementing Large Cardiovascular Outcomes Trials

Webinar hosted by Zoran Antonijevic & Paul Strumph

Speeding Early Development with Simulation & Biomarkers:
Phase 1b Biomarker PoC + Dose-Finding / Phase 2b Clinical Endpoint Dose-Finding / Phase 3 Dose-Choice

Webinar hosted by Nitin Patel, Jim Bolognese & Jaydeep Bhattacharyya

Transforming Oncology Clinical Development with Adaptive Studies

Webinar hosted by Cyrus Mehta and John Grous