New publication addresses critical issues in ultra-orphan indications

Posted by Cytel

Nov 5, 2018 7:01:00 AM

Cytel biostatisticians Cyrus Mehta and Lingyun Liu, together with Charles Theuer, CEO of TRACON Pharmaceuticals have recently co-authored a publication in the journal Annals of Oncology: “ An Adaptive Population Enrichment Phase 3 Trial of TRC105 and Pazopanib Versus Pazopanib Alone in Patients with Advanced Angiosarcoma (TAPPAS Trial)”. The paper explores the features of this innovative...

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Topics: clinical research, clinical trials, Oncology, Precision Medicine, adaptive trials, adaptive designs, adaptive sample size re-estimation, population enrichment


Interview: Promoting precision medicine using data science 

Posted by Cytel

Jan 23, 2018 10:36:00 AM

 News Medical interviewed Dr. Rajat Mukherjee, Statistician, and Director of Data Science at Cytel to investigate the potential of data science in clinical development.

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Topics: data science, big data, Precision Medicine, biomedical signals, Simulation & Biomarkers


Practical Challenges of the LUNG-MAP study

Posted by Cytel

Sep 27, 2016 9:24:00 AM

The Lung-MAP  trial is an innovative biomarker driven 'precision medicine' study which evaluates five novel agents for the treatment of patients with advanced squamous cell carcinoma of the lung.  As well as exploring therapeutic options for this indication, it also aims to improve the drug development process. 

At a Cytel seminar earlier in the year, Antje Hoering of CRAB presented to...

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Topics: Clinical Development Strategy, phase 2, Phase 3, Oncology, Precision Medicine, EDC


Evidence Based Medicine: 25 Years Later

Posted by Esha Senchaudhuri

Jul 27, 2015 5:47:00 PM

We were saddened to learn earlier this year, of the passing of Professor David Sackett. Widely recognized as the father of evidence based medicine, Professor Sackett confronted tough criticism in advancing the cause of evidence based medicine during the early nineties. During his four years at the Centre for Evidence Based Medicine at Oxford, Sackett’s team produced an array of books, articles,...

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Topics: Precision Medicine, Evidence Based Medicine


Relative Clinical Efficiency and Phase 2 Biomarker Studies

Posted by Esha Senchaudhuri

Apr 9, 2015 11:37:00 AM

Last year. Nature Reviews Drug Discovery asked the FDA’s Tatiana Prowell (Hematology & Oncology Products Division) about the most common pitfalls confronting clinical trials in oncology. She cited the late stage evaluations of biomarkers as one of three critical issues leading to regulatory failure [1]. The primary lesson: those who want to test biomarkers need to start earlier.  

OncoMed’s Eric...

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Topics: Oncology, Predictive Enrichment, Precision Medicine, Clinical Development Strategy, Statistical Innovations in Clinical Development


Translational Statistics: How to Move Beyond the Comfort Zone

Posted by Esha Senchaudhuri

Nov 6, 2014 11:09:00 AM

Professor LJ Wei holds that rules are for lawyers, not (necessarily) clinicians. When designing modern clinical trials, the impetus is often to use “efficient and reliable procedures, to obtain clinically interpretable results with respect to risk-benefit analysis…” Yet these efficient and reliable procedures are often just conventions and rules that provide information that is incomplete or...

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Topics: East, East 6.3, Access to Slides PDF, Trial Design, Trial Monitoring, Training and Education, Predictive Enrichment, Precision Medicine, Translational Statistics, Translational Medicine


New Exploratory Trial Method Translates into Better Financial Strategy

Posted by Esha Senchaudhuri

Nov 4, 2014 8:30:00 AM

A key stage of exploratory drug development is implementing a proof-of-concept study to demonstrate the safety of a drug. Given the importance of accurate dose-finding for Phase 3 success, methodological improvements to proof-of-concept studies in Phase 2 can translate into greater likelihood of getting a drug to market. 

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Topics: Oncology, Access to Slides PDF, Enrichment, Safety, Precision Medicine, Entrepreneurship, R&D, Adaptive Clinical Trials


5 Reasons to Invest in Adaptive Designs for Population Enrichment

Posted by Esha Senchaudhuri

Jul 8, 2014 6:00:00 AM

The above graphic is from Cyrus Mehta's slides on 'Adaptive Population Enrichment for Oncology Trials with Time to Event Endpoints.'

 

Recent advances in precision medicine have meant that therapeutic treatments can now target subsets of a population that are most likely to respond well to treatment. Identification of such subsets largely relies on the presence or absence of particular...

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Topics: Oncology, Predictive Enrichment, Precision Medicine, Adaptive Clinical Trials


Adaptive Designs for Precision Medicine: A Look at Pfizer's Xalkori Trial (Slides Attached)

Posted by Esha Senchaudhuri

Jun 26, 2014 8:44:00 AM

The rise of biomarker based treatments in oncology has meant a reconceptualization of what constitutes a particular disease. According to the American Society for Clinical Oncology, “We can no longer think of cancer as one disease. Even something like lung cancer could be hundreds of different cancers, each defined by specific molecular characteristics requiring different treatment...

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Topics: Oncology, Access to Slides PDF, Precision Medicine, Adaptive Clinical Trials


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