Inside an Oncology Statistician's Toolkit

Posted by Adam Hamm

Feb 9, 2017 7:34:58 AM

 

 

 In this blog, Adam Hamm, PhD, Director Biostatistics at Cytel shares some of the most important knowledge he uses in  his day to day work as a biostatistician working extensively in oncology research. Adam has broad experience with statistical analysis and methodology over all phases (I-IV) of development, in particular working in the oncology arena. 

 As a Director of Biostatistics at...

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Topics: Oncology, Dose-Escalation, Interim Analyses, Phase 1, Dose-Finding, Early Phase Trials, Phase 3, phase 2, biostatistics, adaptive trials


Accelerating development with combined SAD/MAD approach

Posted by Cytel

Jan 30, 2017 9:50:24 AM

Single ascending dose (SAD) and multiple ascending dose (MAD) studies are typically the first in human studies.  They seek to gain information on safety and tolerability, general pharmacokinetic (PK) and pharmacodynamic ( PD)  characteristics, and of course identify the maximum tolerated dose (MTD).

Conventionally, SAD  and MAD studies were conducted separately, but increasingly are combined...

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Topics: Cytel Strategic Consulting, Cytel Consulting, Statistical Programming, Phase 1, Dose-Finding, Compass, Phase I, biostatistics, adaptive designs, adaptive trials


How does the T-Statistic stack up for finding MTD?

Posted by Cytel

Aug 23, 2016 9:00:00 AM

At the recent JSM meeting in Chicago, Cytel's Jim Bolognese presented the results of work he has conducted evaluating the T-Statistic ( or T-Stat) method for adaptive dose finding of MTD.  In this blog we'll provide a brief summary of Jim's findings, and share his slides with our blog readers.

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Topics: East, Dose-Escalation, Dose-Finding, Compass, biostatistics, adaptive designs, adaptive trials


PROC MCPMod in Bronchodilator Case Study

Posted by Cytel

Jul 5, 2016 8:00:00 AM

 

At a recent PhUSE SDE, Cytel’s Chitra Tirodkar presented how East PROC MCPMod could be used  to  help solve the problem of uncertain true dose-response relationship in a bronchodilator study.  In this blog we summarize some of the issues, and make Chitra's slides available for download. 

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Topics: East, Statistical Programming, Dose-Finding, Dose Selection, MCP-Mod, EAST 6.4, SAS


A Competitive Alternative to Model-Based Dose-finding

Posted by Cytel

Nov 19, 2015 4:00:00 PM

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Topics: Dose-Finding, BLRM


Takeda Pharmaceuticals' Ling Wang Talks Model-based Dose-finding Designs

Posted by Cytel

Nov 16, 2015 4:30:00 PM

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Topics: Dose-Finding, BLRM


Mitigate Phase 3 Clinical Trial Risk by Optimizing Phase 2 Data

Posted by Esha Senchaudhuri

Aug 10, 2015 2:32:34 PM

When approaching a Phase 3 clinical trial, the need to ‘de-risk’ the massive investment often leads sponsors on a quest for the perfect risk mitigating adaptation. While a strategically planned clinical trial design can be an important step in giving a new medicine its best possible chance of success, there are a number of other ways that a trial sponsor can minimize study risk.

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Topics: Dose-Finding, Early Phase Trials, Proof-of-Concept, Clinical Data, MCP-Mod


Phase 2 Designs for Clinical Utility Limiting Therapies

Posted by Esha Senchaudhuri

Apr 16, 2015 5:28:00 PM

When testing certain types of new drugs it is known in advance that the adverse side-effects of the medication will limit dose selection. For example, it is well-established that for many new pain medications, the side effects of nausea and vomiting will place constraints on the selection of higher dose levels.

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Topics: Dose-Finding, Adaptive Clinical Trials


Adaptive Clinical Trial Strategies for the Limited Early Phase Budget

Posted by Esha Senchaudhuri

Jan 22, 2015 9:00:00 AM

 

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The Journal of the American Medical Association recently published an article entitled ‘The Anatomy of Medical Research: US and International Comparisons.’ The stated objective of the study was to “quantify total public and private investment and personnel (economic inputs) and to evaluate resulting patents, publications, drug and device approvals, and value created (economic outputs)“...

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Topics: Dose-Finding, Early Phase Trials, Proof-of-Concept, Case Study, Adaptive Clinical Trials


Drug Supply Planning for Dose-Ranging Adaptive Trials

Posted by Esha Senchaudhuri

Dec 9, 2014 12:17:28 PM

When planning a conventional trial, one can anticipate the drug supply necessary for the trial by determining how the number of patients reflected in the sample size will distribute across the trial sites. Implementing an adaptive trial, by contrast, raises many challenges for predicting the necessary drug supply. It can require planning for different sample sizes depending on the outcome of...

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Topics: Nitin Patel, Access to Slides PDF, Bayesian Methods, Interim Analyses, optimization, Dose-Finding, Adaptive Clinical Trials


Operationally Seamless & Inferentially Seamless Adaptive Designs

Posted by Esha Senchaudhuri

Dec 4, 2014 11:30:00 AM

Fulyzaq® from Napo/Salix was the first drug ever to be approved using an adaptive two-stage "seamless" clinical trial design. However, when Napo Pharmaceuticals sought orphan drug status for Crofelemer (made from the croton lechleri plant, pictured above left), it received a short window from the FDA in which to complete a Phase 3 trial for safety and efficacy. Aiming to diminish both time and...

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Topics: Sample Size, Trial Design, Safety, type 1 error, Dose-Finding


Ranking Adaptive Dose-Finding Designs using Clinical Utility Functions

Posted by Esha Senchaudhuri

Nov 12, 2014 4:04:25 PM

Clinical utility functions provide Phase 2 trial sponsors with an intuitive metric by which to measure the quality of a selected dose. Such functions reveal the efficacy-to-tolerability ratio of doses under consideration, thereby enabling trials to move forward with doses that are highly effective and which have minimal side-effects. While this is arguably the most popular use of clinical utility...

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Topics: Dose-Finding, Adaptive Clinical Trials


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