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


An efficient tool for model based meta-analysis

Posted by Cytel

Sep 20, 2016 9:42:00 AM

 

Drug development is an expensive and risky business.  To maximize a compound’s ultimate chances of commercial as well as regulatory success it’s imperative that sponsors are building up a strong understanding of its characteristics relative to competitors.  This knowledge can support critical decisions along the development path, such as optimizing dosing, and selecting the best active...

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Topics: pharmacology, pharmacometrics, clinical development, Clinical Development Strategy


Case Study:Exposure Response Modeling in Hematology

Posted by Cytel

Sep 13, 2016 10:15:00 AM

 

Exposure-response data gained from clinical studies can provide a basis for model-based analysis and simulation, helping to predict the expected relationships between exposure and response.  Using this approach, it may be possible to optimize dosage regimens and to individualize treatment in specific patient subsets for which there are limited data.  In this blog, we examine a case study of...

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Topics: biostatistics, Phase 3, Cytel Strategic Consulting, pharmacology, pharmacometrics, PK/PD


Case Study:Seamless Phase 2/3 Design in Rare Disease

Posted by Cytel

Sep 9, 2016 9:24:00 AM

 

Challenge:

Our client, an emerging biotechnology company, was preparing for the next stage of development for their novel compound in a rare disease.  They had two major concerns which they wanted the clinical trial design to address- an anticipated difficulty in recruiting subjects to the trial, and  the cost and time investment associated with running separate phase 2 and phase 3 trials. ...

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Topics: biostatistics, adaptive trials, EAST 6.4, Seamless designs, phase 2, Phase 3, Clinical Research Services, Cytel Strategic Consulting


Overcoming challenges of 'Less Well Understood' Adaptive Designs

Posted by Cytel

Sep 7, 2016 8:00:00 AM

In the 2010 draft FDA ‘Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics',  the agency makes an important distinction between ‘well understood’ and ‘less well understood’ adaptive designs.

‘Well understood” adaptive designs may include such approaches as adaptation of eligibility criteria, adaptation for stopping early and adaptations to maintain study power...

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Topics: Clinical Research Services, adaptive trials, adaptive designs, type 1 error, Software Simulations, DMC, sample size re-estimation, patient enrollment


Case Study: BLRM for Phase 1/2a Oncology Study

Posted by Cytel

Sep 2, 2016 10:30:00 AM

 

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Topics: biostatistics, adaptive trials, Dose-Escalation, EAST 6.4, East ESCALATE, BLRM, CRM, Oncology, Early Phase Trials, Eearly Development


An Introduction to BLRM

Posted by Cytel

Aug 31, 2016 1:11:57 PM

Traditional rule-based approaches to dose escalation such as 3+3 are widely used in early clinical development. They can be appealing due to the simplicity of execution. However, estimates produced may be highly variable and the targeting of true Maximum Tolerated Dose may be poor.  Bayesian dose escalation approaches in early phase trials can offer an effective alternative to determining the...

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Topics: biostatistics, adaptive trials, Dose-Escalation, EAST 6.4, East ESCALATE, BLRM, CRM


Unblinded Sample Size Re-Estimation in Bioequivalence Trials with Small Samples

Posted by Cytel

Aug 26, 2016 11:30:00 AM

 

At the recent JSM in Chicago, Cytel’s Sam Hsaio and Lingyun Liu alongside Genentech's Romeo Maciuca, presented a framework for inference in adaptive bioequivalence trials with unblinded sample size re-estimation.

 

The Problem

In bioequivalence trials where the variance is often unknown, and the sample size small, using boundaries derived under the assumption of a normally distributed test...

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Topics: sample size re-estimation, Lingyun Liu, JSM, biostatistics, adaptive trials, Sam Hsaio


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


Adaptive Designs: In Conversation with the NEJM

Posted by Cytel

Aug 17, 2016 11:57:43 AM

Following the recent publication of their review article Adaptive Designs for Clinical Trials in the New England Journal of Medicine,  co-authors Cyrus Mehta ( President and Co-Founder of Cytel, and Adjunct Professor of Biostatistics at Harvard University) and Deepak L. Bhatt M.D C M.P.H. (Executive Director of Interventional Cardiovascular Programs, Brigham and Women’s Hospital Heart and...

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Topics: biostatistics, adaptive trials, adaptive designs, Cyrus Mehta, Promising Zone


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


The CRO role in Data Standards Governance

Posted by Cytel

Aug 2, 2016 10:30:00 AM

Editor's note( this blog was refreshed in April 2018)

As CDISC compliant submissions become increasingly expected, biopharmaceutical companies are considering how to approach the issue of data standards governance.  Standards governance is a lynchpin in the management of CDISC compliance and is important for promoting standards awareness within organizations. It’s also an acknowledged hot...

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Topics: Data Management, Clinical Research Services, Clinical Data, EDC, database build, data manager, CDM, Statistical Programming, SDTM, ADaM, CDISC, CDASH


6 steps to timely database lock

Posted by Cytel

Jul 28, 2016 10:06:00 AM

To close a clinical database right the first time you have to begin with study start-up. Clearly, you can’t close a database if the data is not cleaned and you can’t have clean data unless you know what is most important for analysis. It’s imperative that data management works closely with the statistics group during CRF/ eCRF design to ensure data is being collected and data checks are being...

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Topics: big data, EDC, data manager, Clinical Data, database build, Clinical Research Services, Data Management


5 trends a statistical programmer needs to follow

Posted by Cytel

Jul 25, 2016 12:00:00 PM

Statistical programmers are in high demand within the biopharmaceutical industry, and within the dynamic world of clinical trials the part they play is ever evolving.  In this blog, we take a look at 5 trends which are shaping their roles in 2016 and beyond. 

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Topics: CDISC, Statistical Programming, SAS, R programming, big data


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


Adaptive Design in the limelight with NEJM article

Posted by Cytel

Jul 18, 2016 8:00:00 AM

In order for adaptive designs to reach their potential, it’s critical that knowledge is effectively dissemirnated within the medical research community – in particular detailed information about the operating and statistical characteristics of specific designs and insights as to their benefits and limitations. 

Cytel recently announced the publication of an important article in the New England...

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Topics: biostatistics, adaptive designs, Adaptive Clinical Trials, sample size re-estimation, phase 2, Phase 3, Seamless designs


Key considerations in selecting an EDC system

Posted by Cytel

Jul 12, 2016 9:00:00 AM

 How do you go about selecting the best Electronic Data Capture (EDC) system for your study?  There is now a vast amount of choice in the market, and many factors to take into account before making your decision.  Different stakeholders within the business may also have different perspectives, so any decision making process needs to balance these disparate needs.  

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Topics: Data Management, Clinical Research Services, Clinical Data, EDC, database build, data manager, CDM


Wild Horses: How StatXact is helping conservation project in Mongolia

Posted by Cytel

Jul 7, 2016 10:30:00 AM

 

Why do we do what we do?  At Cytel we have always been driven to deliver benefits in the service of human health, and ultimately to bring new drugs to the patients who need them.  In the context of our work in statistical software, we have recently had the opportunity to support an important conservation project defined by a similar passion to make a difference.  

While our core focus has...

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Topics: Statistical Programming, Simulations, biostatistics, StatXact, exact statistics, non parametric analysis


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


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