Operational and regulatory considerations in a promising zone trial

Posted by Cytel

Aug 9, 2016 9:00:00 AM

At the recent JSM Meeting, Cytel’s Yannis Jemiai presented the case study of the VALOR trial which used a promising zone design. At the time of the study, existing therapy for relapsed or refractory AML was generally unsatisfactory with no approved drugs available for patients, and a very poor prognosis.  Vosaroxin was a first-in-class anticancer quinolone derivative which had previously been...

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Topics: Clinical Research Services, Regulation, biostatistics, adaptive trials, adaptive designs, Oncology, ACES, DMC


Webinar Replay: Single and Double Agent Dose Escalation Designs

Posted by Cytel

Jul 21, 2016 6:30:00 AM

Did you miss our webinar on Single and Dual Agent Dose escalation designs earlier in the year?  In this blog we have made the replay available for your review, and  also  take the opportunity to recap key reasons why you should consider a model based design for your dose escalation study.

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Topics: Oncology, Dose-Escalation, Bayesian Methods, EAST 6.4


5 session picks for the JSM

Posted by Cytel

Jul 20, 2016 8:30:00 AM

The Joint Statistical Meetings is the largest and arguably most highly respected gathering of statisticians in the world.  It will bring together over 6000 statisticians for this year’s event in Chicago.   As a large meeting, it can be a challenge to navigate and find the sessions which are going to be most valuable for your work.  To help out, we've asked some of the leading lights of our...

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Topics: biostatistics, Biometrics, Oncology, JSM, Trial Design, adaptive trials


Overcoming Data Management Challenges in Oncology Studies

Posted by Cytel

Apr 26, 2016 11:30:00 AM

In this blog we’ll highlight some unique challenges that are encountered from a Data Management perspective when working on early phase Oncology trials. We’ll also discuss approaches which can be employed to mitigate these issues.  

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Topics: Oncology, Data Management, Clinical Research Services, Phase 1, Clinical Data, phase 2, EDC, database build, data manager, CDM, Biometrics


Dual Agent Dose Escalation Designs

Posted by Cytel

Apr 22, 2016 9:30:00 AM

FDA draft guidance on “Co development of two or more unmarketed investigational drugs for use in combination”  notes that:

“Combination therapy is an important treatment modality in many disease settings, including cancer, cardio-vascular disease, and infectious diseases. Recent scientific advances have increased our understanding of the pathophysiological processes that underlie these and...

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Topics: Oncology, Phase 1, Early Phase Trials, Adaptive Clinical Trials, BLRM, Bayesian, PIPE


HTAs: Adjusting Overall Survival for Treatment Switch

Posted by Cytel

Apr 13, 2016 11:00:00 AM

 

We continue our series of blogs covering the expert presentations from the EAST User Group Meeting. Consultant Claire Watkins of Clarostat provided a different statistical focus, moving the discussion to a later point in the product lifecycle and the area of Health Technology Assessment.  Her presentation, which tackled the topic of Adjusting Overall Survival for Treatment switch, shared the...

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Topics: Oncology, FDA, NICE, HTA, health economics, treatment switch


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


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


Adaptive Dose Finding Using Toxicity Probability Intervals

Posted by Esha Senchaudhuri

Oct 28, 2014 9:30:00 AM

Phase 1 oncology trials typically use either rule-based methods or model-based methods to determine the most acceptable level of dose toxicity with which to move forward in Phase 2. This level of toxicity, called the maximum tolerated dose (or the MTD), is the dose which best balances the medical benefits of a higher dose with the risk of toxicity which comes from subjecting a patient to that...

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Topics: Oncology, East 6.3, Access to Slides PDF, East ESCALATE, Adaptive Clinical Trials


5 Scenarios When ‘Keep it Simple’ May Be Bad Advice for Clinical Trial Designers

Posted by Esha Senchaudhuri

Sep 18, 2014 10:44:00 AM

When designing clinical trials, many trial designers are advised to keep the trial simple. Prima facie, the keep it simple principle seems like sound advice. There are various logistical uncertainties that arise when implementing a clinical trial, and the more simple a trial – so conventional wisdom says – the easier it is to respond to these uncertainties.

According to Zoran Antonijevic, a...

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Topics: Oncology, Promising Zone, sample size re-estimation, Enrichment, Cytel Consulting, Efficacy, Interim Analyses, forecasting, optimization, Program and Portfolio Optimization, R&D, Adaptive Clinical Trials


Mehta Publishes Article on Adaptive Designs for Biomarker Driven Population Enrichment in Oncology

Posted by Esha Senchaudhuri

Jul 10, 2014 1:53:00 PM

Complexities with identifying suitable test populations in oncology studies contribute significantly to the 60% attrition rate in Phase III trials. Cyrus Mehta, (President of Cytel) has recently authored a paper on ‘Biomarker Driven Population Enrichment for Adaptive Oncology Trials,’ (forthcoming in Statistics in Medicine) which provides an innovative method for using two-stage adaptive...

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Topics: Oncology, Access to Paper PDF, Enrichment, 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


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

Posted by Esha Senchaudhuri

Jun 10, 2014 7:01:00 AM

 East: Learn More

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...

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


Powering Oncology Trials for Success: Adaptive Designs in East

Posted by Charles Liu

Jun 5, 2014 9:37:00 AM

Charles Liu, PhD, Cytel Statistician and Product Manager

In the US, cancer is the most common cause of death after heart disease, accounting for nearly 1 of every 4 deaths [1]. Tackling the immense burden of this disease, researchers are currently investigating an estimated 900 novel cancer agents in over 6,000 clinical trials [2]. Unfortunately, the clinical success rate remains low, and failed...

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Topics: Oncology, Education, Adaptive Clinical Trials


De-Risking Drug Development using Adaptive Design

Posted by Cytel

May 13, 2014 8:31:00 AM

The VALOR trial recently applied a promising zone design to a Phase 3 evaluation of Vosaroxin, a candidate for the treatment of relapsed/refractory acute myeloid leukemia. CMO Dr. Adam Craig reports that there were intial anxieties about financing a trial that required 800 patients. However, a promising interim look raised investors' confidence in the treatment's success, leading to a...

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Topics: Oncology, Promising Zone, sample size re-estimation, Movers & Shapers, Adaptive Clinical Trials


5 Reasons to Invest in Bayesian Dose-Escalation Methods

Posted by Esha Senchaudhuri

May 8, 2014 7:54:00 AM

( Editor's note: This post has been refreshed in December 2016)

Model based algorithms for Phase I dose-escalation have been in existence for nearly thirty years. Despite guarantees of increased statistical power and greater accuracy, there remains a clear preference for rule based algorithms amongst clinicians. The explanation for this is as old as the models themselves.

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Topics: Oncology, Dose-Escalation, Bayesian Methods, EAST 6.4, East ESCALATE


StatXact 25th Anniversary: A Horizon for the Stars

Posted by Esha Senchaudhuri

Apr 21, 2014 3:57:00 PM

The core methodological problem that would eventually spur the development of Cytel’s StatXact software was first posed by Harvard’s Marvin Zelen at a computational seminar in the late 1970s. Zelen, a distinguished professor of statistical sciences and head of the Department of Biostatistics at Harvard University, was also serving as the Director of the Dana Farber Cancer Institute.

The...

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Topics: StatXact, Nitin Patel, Cyrus Mehta, White Paper, Statistics Article full PDF, Oncology, Access to Paper PDF, Exact Tests, Marvin Zelen, Statistical Puzzles


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