Data-Driven Trial Planning: An Interview with Pfizer's Chris Conklin

Posted by Cytel

Feb 12, 2015 2:59:00 PM

Data driven decision-making can ensure that every feasibility team achieves its enrollment milestones. By transforming how pharmaceutical companies and CROs conduct feasibility studies, new techniques in recruitment planning are affecting every aspect of trial planning and clinical development strategy.

We sat down with Chris Conklin, the Director of the Feasibility Center for Excellence at...

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Topics: Clinical Development Strategy, feasibility studies, patient enrollment


How to Shorten a Cardiovascular Outcome Trial By Two Years

Posted by Esha Senchaudhuri

Feb 10, 2015 5:28:00 PM

Cardiovascular outcome trials (CVOTs) have earned the reputation of being the untamable behemoths of the clinical world. Needless to say these trials are long and require extremely large sample-sizes. The Contrave LIGHT study required 8900 patients. The SAVOR TIMI trial enrolled 16,492 patients. Even the EXAMINE trial, which benefited from a promising zone design, required 650 patients. 

However,...

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Topics: Cyrus Mehta, Promising Zone, Cytel Strategic Consulting, Interim Analyses, Program and Portfolio Optimization, Cardiovascular, Clinical Development Strategy


Why Drugs Fail in Phase 3: A Cytel Infographic

Posted by Esha Senchaudhuri

Jan 20, 2015 10:30:03 AM

According to a recent Cytel Whitepaper on Adaptive Clinical Trials, 50% of Phase 3 trials eventually fail. This new Cytel Infographicoffers a breakdown of why so many drugs fail in Phase 3.

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Topics: Early Phase Trials, Clinical Development Strategy, Phase 3


Simulation and Prediction for Adaptive Licensing Decision-Making

Posted by Esha Senchaudhuri

Jan 13, 2015 3:03:54 PM

Janus was the Roman God of transitions, a deity with two faces, one looking towards the past and the other the future. It was only a matter of time therefore, that clinical trial simulators, and other purveyors of predictive analytics would adopt him as an embodiment of their core initiatives. The aptly named Janus Initiative aims to model decision pathways in clinical development, using...

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Topics: Prediction, Clinical Development Strategy, Software Simulations, Adaptive Licensing


Early Phase Development Strategy: Bayesian Methods for Go/No-Go Rules

Posted by Esha Senchaudhuri

Dec 18, 2014 3:40:00 PM

Earlier this week, we at Cytel enjoyed a riveting in-house discussion on the uses of Bayesian decision rules for Go/No-Go (GNG) decision-making. GNG rules establish the trajectory of a particular clinical program’s development by assessing whether or not a trial has met particular objects (e.g. target regions for PK, PD and safety endpoints.)

Traditionally, statisticians have used p-values and...

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Topics: Early Phase Trials, Clinical Development Strategy, Adaptive Clinical Trials


Cultivating Versatility in Statistical Consultants

Posted by Esha Senchaudhuri

Dec 16, 2014 4:56:00 PM

Richard Branson once wrote: “I have always valued capability over expertise. While you may need to hire specialists for some positions, take a close look at people who have thrived in different industries and jobs – they are usually more versatile, have transferable skills, and can potentially tackle problems creatively.”

He goes on to write: “Obviously a healthy mix of experience and novel...

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Topics: Nitin Patel, Cytel Consulting, Entrepreneurship, Clinical Development Strategy, Richard Branson


Adaptive Designs for Infectious Diseases Clinical Development Strategy

Posted by Esha Senchaudhuri

Dec 11, 2014 1:14:00 PM

 

A common framework for the clinical development of vaccines involves the study of several candidate compounds in Phase 1 followed by the selection of potential vaccine regimens for study in Phase 2 and Phase 3. In the attached presentation, Cytel Consulting’s Jim Bolognese compares traditional and adaptive Phase 1/Phase 2 studies for vaccines and infectious diseases, providing simulations...

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Topics: Infectious Diseases, Clinical Development Strategy, Adaptive Clinical Trials


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