Infographic: 9 Do's and Don'ts to Ensure Independence of QC in Statistical Programming

Posted by Cytel

Nov 14, 2016 8:13:29 AM

In our last blog, we shared some of Angelo Tinazzi and Cedric Marchand's recommendations on how to ensure independence of QC in statistical programming.  Now, we've put together an infographic highlighting some key do's and don'ts in a handy checklist.  

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Topics: Statistical Programming, biostatistics, SDTM, ADaM


Challenges in Neuroscience Clinical Trials

Posted by Cytel

Oct 5, 2016 9:48:00 AM

 While some progress has been made in terms of scientific development in Neuroscience and Neuropsychiatry indications, the pace of translation into more effective treatments  remains elusive.

 At the recent Cytel seminar co-hosted with Pfizer, Abdul J. Sankoh of Sage Therapeutics presented on some of the challenges in these therapeutic areas and discusses strategies moving forward.  He bases his presentation on his broad industry experience. 

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Topics: Clinical Research Services, psychiatry and neuroscience, biostatistics, adaptive designs, adaptive trials


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 an exposure response modeling project conducted by our Quantitative Pharmacology and Pharmacometrics team. 

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Topics: Cytel Strategic Consulting, Phase 3, pharmacometrics, biostatistics, pharmacology, 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.  They approached Cytel’s strategic consulting team for an innovative solution.

Solution:

An inferentially seamless Phase 2/ 3 design with promising zone was proposed as a means to address the sponsor’s objectives. Because of uncertainty regarding which dose would be selected and what the effect size of the selected dose would be, the team proposed design options which allowed for adjustment of the sample size using information learned at the interim analysis.  Several seamless phase 2/3 designs, with and without adaptive sample size re-estimation were evaluated through simulations using East 6.4.

The simulations evaluated various design parameters such as maximal sample size, timing of the interim analysis, size of the promising zone, and efficacy and futility boundaries. Designs were compared on the basis of overall power, average sample size, conditional power, probability of entering each interim zone, and number of overruns.

Value Added:

The inferentially seamless design has the potential to accelerate clinical development by removing the ‘white space’ between phases 2 and 3.  Where the sample size is increased adaptively at the interim analysis by a specified percentage of the original pre-planned sample size, an overall increase in power could also be achieved.  The sample size re-estimation design provided a boost to power where the interim results fell  in the promising zone.  The client benefited from a design which only calls for additional investment of patients and resources when this investment would meaningfully boost the chances of success.

Cytel's statistical consulting team help you decide if an adaptive approach is right for your trial. Read further examples of our work by clicking below. 

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


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

Posted by Cytel

Sep 2, 2016 10:30:00 AM

 

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


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 maximum tolerable dose of a new drug more quickly, as well as ensuring that all of the information available to trial clinicians is taken into account so that the patients enrolled in the trial receive the best possible treatment.

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


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 statistic may lead to type I error inflation. This problem can be overcome with p-value combination methods, however these approaches generally do not directly provide confidence intervals for the geometric mean ratio on the scale of the original pharmacokinetic endpoint.

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Topics: sample size re-estimation, biostatistics, Lingyun Liu, adaptive trials, JSM, 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: East, Dose-Escalation, Dose-Finding, Compass, biostatistics, adaptive designs, adaptive trials


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 Vascular Center) were invited to participate in a live video discussion with the journal. 

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


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 studied in a single arm Phase 2 study. In this blog we'll take a look at the operational and regulatory considerations in the implementation of this trial, which were highlighted during Jemiai's talk. 

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


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 statistical group which sessions are their top picks this year. 

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


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 Journal of Medicine which takes a leap forward in promoting better understanding of adaptive designs particularly in a confirmatory setting.  We'll discuss some of the highlights of the article in this blog. 

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


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 always been in biostatistics, and thus in the life science industry, our StatXact statistical software is used by customers across a broad spectrum of natural and social sciences thanks to its ability to handle small sample sizes. 

 

The Association Takh is one such customer.  Takh is dedicated to the re-introduction of the world’s last wild horse, as well as conservation in Mongolia and improvement of the lives of Mongolian herders.  (1) In 2004 and 2005 the association reintroduced 22 Przewalski’s horses( one of the world’s most endangered species)  from Le Villaret in southern France to the buffer zone of Khar Us Nuur National Park in the Khomyn Tal herder community of western Mongolia.

 

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


The Rise of R-should SAS programmers get up to speed?

Posted by Cytel

Jun 29, 2016 8:00:00 AM

 

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Topics: Statistical Programming, Simulations, biostatistics, SAS, R programming


Sharpening your Advanced SAS Skills: Interview with Sunil Gupta

Posted by Cytel

Jun 21, 2016 10:30:00 AM


Sunil is an Associate Director of Statistical Programming at Cytel and has over twenty-five years of experience in the pharmaceutical industry.  He is also an international speaker and best-selling SAS author.  Most recently, Sunil contributes his knowledge as a CDISC Oncology ADaM reviewer and has taught his CDISC online classes with the University of California at San Diego.  Sunil has MS in Bioengineering from Clemson University and a BS in Applied Mathematics from the College of Charleston.
Recently, Sunil published a book, 'Sharpening your Advanced SAS Skills’ a follow up to his popular and well respected ‘ Sharpening your SAS Skills’. In this blog we find out more and offer blog readers the chance to win a copy of the new book!

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Topics: Statistical Programming, Training and Education, biostatistics, SAS


Managing DMC analysis- an innovative programming solution

Posted by Cytel

Jun 14, 2016 8:00:00 AM

At Cytel, we are very often asked to get involved in DMCs ( Data Monitoring Committees)  in a variety of capacities. Our statistical experts are recognized for their work in many of the areas related to DMCs including-group sequential and adaptive designs, multiplicity, missing data, and decision sciences.  One key operational management issue when producing analysis for DMCs  is that rules must be defined so that trial unblinding is not compromised and bias remains controlled.  In this blog, we will explore an innovative approach developed by members of our statistical programming team to improve the efficiency of this process, while maintaining the highest levels of data security. 

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Topics: Clinical Research Services, Statistical Programming, Interim Analyses, Blind and Unblind Trials, Clinical Data, ACES, biostatistics, DMC


How can the CMO/Biostatistician connection improve clinical development?

Posted by Cytel

Jun 7, 2016 8:00:00 AM

 At the recent CMO Summit East  James ( Jim) Bolognese, Cytel’s Senior Director of Strategic Consulting, and Lou Vaickus,MD, FACP, Founder and President of aktaPD jointly explored how the critical connection between a CMO and a biostatistician can help enhance communication with internal and external stakeholders, ensure patient safety and ultimately improve clinical development efficiency.  Below you can catch up with some of the key topics they covered and watch the video of the presentation. 

 

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Topics: Clinical Development Strategy, go-no-go, clinical development, biostatistics, p value


EAST 6.4 Release: Interview with Yannis Jemiai

Posted by Cytel

May 31, 2016 7:30:00 AM

 

Last week, we were delighted to announce the release of East 6.4 bringing further cutting –edge approaches to the East user community. East is the industry standard platform for clinical trial design, simulation, and monitoring, improving scientific productivity during the critical planning stages of clinical development. In this blog we catch up with Yannis Jemiai, VP of Cytel  to gain some behind-the-scenes insights into the development and  new features of this important release.

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Topics: East, Bayesian Methods, East PREDICT, Prediction, Software Simulations, Multi-Arm Studies, Multi-Arm Multi-Stage Studies, biostatistics, EAST 6.4, adaptive trials


Highlights from the PSI Conference

Posted by Cytel

May 26, 2016 11:37:20 AM

A number of the Cytel team were in Berlin 22nd- 25th May  for the PSI Annual conference.  The PSI Conference is an important forum for statisticians and we found this year's event to be energetic, technically interesting and well attended.  In this blog, we’ll summarise some of the particular highlights from the sessions that our team members attended.

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Topics: Clinical Data, biostatistics, adaptive designs, adaptive trials, PSI Conference


Pattern Recognition and 'Big Data'

Posted by Cytel

May 19, 2016 6:00:00 AM

The explosion in healthcare information and “big data “has been one of the most written about topics in the last few years. These big data in the form of electronic health records, diagnostic tests, genomics, proteomics, not to mention data from wearable devices and apps have the potential to transform healthcare.  That potential can only be realized though through the application of advanced analytics to recognize patterns from the vast information available. As such, disciplines such as pattern recognition play a pivotal role in the future of healthcare.

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Topics: Bayesian Methods, Computing, Clinical Data, biostatistics, machine learning, big data, pattern recognition


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