Overcoming Prowell's Pitfalls: Cytel Weighs in on Strategies for Oncology Development

Posted by Esha Senchaudhuri

Jun 10, 2014 7:01:00 AM

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The FDA’s Tatiana Prowell (Breast Cancer Scientific Lead in the Office of Hematology  & Oncology Products) recently gave an interview to the Nature Review Drug Discovery, in which she discusses the top three pitfalls faced by drug developers in oncology. Issues which Prowell cite include: selection of appropriate dosage, trial designs without sufficient thought given to interim data, and untimely decisions on the use of biomarkers.

According to the article, “some 90% of drugs that enter phase 1 eventually fail.” The prevalence of these pitfalls is noteworthy for oncology drug development, not least becaues of how easy they are to avoid.When coupled with innovative trial design can achieve significant benefits in efficacy and cost-effectiveness. For example, model-based dose-escalation methods can be used to improve the model dose toxicity profile of the drug in question. Cytel Statistician Charles Liu shows how simple it is to use Cytel’s software to select the optimal dose to carry forward.

Cytel Consulting is also familiar with creating designs that balance efficacy and toxicity in dose selection. Jim Bolognese, a Senior Director at Cytel Consulting, recently presented a study at the Annual CMO Meeting about using clinical utility functions to optimize dose.

When designing trials with interim analyses, East is the standard package for adequate and well-designed clinical trials. Sensitivity analysis for appropriate design of interim analyses can factor in accrual duration, study duration, event accumulation, and so forth. The East PREDICT module can help assess chances of success as the trial progresses. Using a promising zone design can help rescue underpowered but promising studies.

As far as the use of biomarkers is concerned, stay tuned for an upcoming post on a recent paper by Cytel President Cyrus Mehta; and come see Zoran Antonijevic at the Annual DIA Meeting where he will be presenting on the use of biomarkers for predictive enrichment


Related Items of Interest

Introduction to DIA panel on Predictive Enrichment by Cytel Consulting Senior Director Zoran Antonijevic.Click here. 

Items Cited in Blog Post

Interview of FDA's Tatiana Prowell (Breast Cancer Scientific Lead) in Nature Review Drug Discovery. Click here

Cytel Statistician Charles Liu on the innovative use of software to power modern oncology trials. Click here

Talk by Cytel Consulting Senior Director Jim Bolognese, on using clinical utility functions to optimize dose. Click here

Notes on predictive enrichment strategies by Cytel Consulting Senior Director Zoran Antonijevic. Click here

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Topics: Oncology, East, Regulation, FDA, East PREDICT, Predictive Enrichment, Interim Analyses, Prediction

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