2018 East User Group Meeting Addresses Multiplicity Themes, with keynotes including Stephen Senn and Meinhard Keiser.

Posted by Cytel

Aug 15, 2018 6:08:00 AM

 

Cytel’s 7th East User Group Meeting (EUGM) will take place on November 14 & 15, 2018 at Merck in Darmstadt, Germany, bringing together industry experts, thought leaders and applied statisticians to discuss the future of clinical trials.

The agenda has been developed collaboratively by the EUGM Scientific Committee, and keynote speakers will include Stephen Senn, Meinhard Kieser, Thomas Burnett, Robert Greene and Simon Kirby.

In this blog, we took the opportunity to talk to one of the speakers, Thomas Burnett, Senior Research Associate in Medical and Pharmaceutical Statistics at Lancaster University, about his presentation topic “Bayesian Optimization of Enrichment Designs” and his perspectives on what EUGM delegates will be able to take away from his talk.

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Topics: East, Bayesian Methods, Trial Design, Program and Portfolio Optimization, Adaptive Clinical Trials, phase 2, Simulations, adaptive designs


Interview: How can a Bayesian framework support benefit risk assessment?

Posted by Cytel

May 30, 2017 8:06:00 AM


A recent paper The case for Bayesian methods in benefit-risk assessment: Overview and future directions (1)  co-authored by Cytel Senior Vice President Consulting  Yannis Jemiai and published in Therapeutic Innovation and Regulatory Science, tackles the critical issue of benefit risk assessment, and the part Bayesian approaches can play in resolving their challenges.

There is certainly an industry- wide need for more transparent, targeted and robust benefit risk assessments. In this blog we talk with Yannis about the article and why the Bayesian framework is particularly well suited to these efforts. 

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Topics: Bayesian Methods, Statistical Analysis, biostatistics, Bayesian, benefit risk assessment


Case Study: Improving Go/No-go Decision-Making with Custom Software

Posted by Cytel

Mar 24, 2017 9:27:00 AM

 Robust go/no-go (GNG) decision-making is essential for effectively managing risk across a clinical portfolio. In early phase development, it is particularly important to have the correct tools in place to terminate ineffective compounds quickly, while accelerating promising ones through the process. 

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Topics: Bayesian Methods, Case Study, go-no-go, biostatistics, Bayesian, custom software


Case Study: Bayesian Decision-Making in a Phase 3 Oncology Design

Posted by Cytel

Mar 2, 2017 8:45:00 AM

We continue our case study series with this example of a Phase 3 design that uses Bayesian decision making combined with frequentist final analysis.

Clinical Development Background

Our biopharmaceutical client’s lead drug candidate is a late clinical-stage cancer immunotherapy for treatment of a rare oncology indication.  Clinical development of therapies in this indication faces inherent challenges of patient recruitment and scarcity of data.

Sponsor Challenge

The sponsor had previously conducted a randomized, double-blind, placebo-controlled Phase 2 study. Moving into a confirmatory clinical trial setting, they came to Cytel for support with a trial design to address their key questions:

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Topics: Oncology, Bayesian Methods, Phase 3, adaptive sample size re-estimation, biostatistics, adaptive trials, Bayesian


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


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


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


Decision Making in Early Clinical Development

Posted by Cytel

Mar 29, 2016 11:00:00 AM

On March 16th and 17th the 5th East User Group Meeting took place in London.  This very successful 2 days saw a variety of talks on aspects of clinical trial design innovation.  Over the next couple of weeks, we will be reviewing some of the key topics which were addressed during the meeting.

In this post, we'll take a look at Paul Frewer of Astrazeneca's presentation on Decision Making in Early Phase Clinical Development.  This talk was very well received by the delegates and prompted plenty of discussion afterwards. 

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Topics: Bayesian Methods, Cytel Consulting, Cytel Videos, Phase 1, Early Phase Trials, phase 2


What's the Value of P?

Posted by Cytel

Mar 23, 2016 9:30:00 AM

“How many statisticians does it take to ensure at least a 50% chance of a disagreement about p-values?” 

So questions George Cobb of Mt. Holyoke College in  his commentary on  the ASA’s 7th March ‘Statement  on P Values: context, process and purpose’

The association took the unprecedented step of publishing the statement following a long litany of criticism of misuse of the P value. This included the decision last year by Journal of Basic and Applied Social Pyschology to restrict the publication of papers where hypothesis testing is used for analysis.

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Topics: Bayesian Methods, p value


2 Talks on Early Phase Go/No-GO Decision Making

Posted by Cytel

Nov 12, 2015 4:00:00 PM

Last week Cytel joined forces with Sanofi/Genzyme to devote a full day of workshops and talks related to modern methods in early phase oncology. Patrick Mitchell, an Associate Director of Statistical Sciences at Astra Zeneca, gave this talk on Bayesian go/no-go decision-making in an early phase oncology event study. 

Astra Zeneca recently invited Cytel to take part in a collaborative initiative to develop software for go/no-go decision-making. Pat demonstrates the uses of this proprietary software in early phase oncology. 

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Topics: Bayesian Methods, Early Phase Trials, Clinical Development Strategy, go-no-go


Bayesian Dose Escalation Designs for Late Onset Toxicity

Posted by Cytel

Nov 10, 2015 4:00:00 PM

Last week Cytel joined forces with Sanofi/Genzyme to devote a full day of workshops and talks related to modern methods in early phase oncology. 

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Topics: Dose-Escalation, Bayesian Methods


P-Values & Pharma Development: We Want to Hear from You

Posted by Esha Senchaudhuri

Oct 27, 2015 6:04:00 PM

Here at Cytel we have enjoyed following the debates on the p-value controversy currently taking place on the ASA website, and indeed debating the issue ourselves. While we plan to post our views on the topic in the weeks to come, we would like to invite your thoughts on the issue as well. 

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Topics: Bayesian Methods, Statistical Analysis


Cytel Case Study Series II: Adaptive Bayesian Design with Informative Prior

Posted by Cytel

Sep 15, 2015 3:56:42 PM

 

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Topics: Bayesian Methods, Cytel Consulting, Case Study, Adaptive Clinical Trials


Modern Early Phase Clinical Trial Design Primer

Posted by Cytel

Sep 1, 2015 4:01:39 PM

If you’re in the practice of conducting early phase clinical trials, you’ve probably heard that modern trial designs include a number of new methodologies. There’s CRM and BLRM, model-based methods versus rule-based methods, and a number of other developments that might affect your clinical strategy. Each of these methods affects operational, financial and regulatory objectives in unique ways.

As a part of this year’s Joint Statistical Meeting, Cytel statisticians created a primer to go along with a workshop for early phase clinical trial design.

In the primer you will find: 

  • 1. An overview of 3+3, CRM, BLRM and mTPI methods
  • 2. A synopsis of basic concepts like Bayesian and frequentist statistics, models and rules, etc.
  • 3. Reflections on regulatory considerations
  • 4. Case studies and topical exercises with Cytel’s high-powered simulations
  • 5. A solution guide for those with access to Cytel's East software  

 Click to download the Primer

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Topics: Bayesian Methods, CRM, Early Phase Trials, Clinical Development Strategy, BLRM


Special Update: US House of Representatives Passes 21st Century Cures Act

Posted by Cytel

Jul 10, 2015 12:54:00 PM

Here at Cytel, we are engaging in a small celebration this afternoon, as the US House of Representatives has just passed the FDA Reform Bill more generally known as the 21st Century Cures Act.

Although this bill is widely viewed as a reform bill, it will provide extensive funding to both the FDA and NIH to ensure that clinical and pharmaceutical research lives up to its potential to deliver life-saving technologies in a faster, smarter way.

Title II of the act contains approximately 150 pages on drug development. We're sure some of you have read it through and through. However, for those putting off their summer reading until August, here are 4 exciting developments that we want all of our friends and affiliates to be aware: 

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Topics: Bayesian Methods, Regulation, Medical Devices, Adaptive Clinical Trials


How Bayesian Strategies Can Expedite a Pediatric Clincial Trial Time by 20 - 40%

Posted by Esha Senchaudhuri

Mar 20, 2015 4:29:00 PM

Sometimes a new candidate drug for a pediatric study has already been tested on adults for safety and efficacy. We know that the drug is likely to work quite differently in children, but we do not know the degree to which the effects will be different. As a result, a conventional approach is to discard much of the information that has already gathered during studies of adults, and then to start from scratch with a pediatric trial.

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Topics: Bayesian Methods, Adaptive Clinical Trials, Pediatric


How Proposed Regulatory Reforms Will Affect Your Clinical Trial

Posted by Esha Senchaudhuri

Feb 17, 2015 6:40:00 PM

21st Century Cures (also called Cures2015) is a bipartisan initiative undertaken by the Committee on Energy and Commerce of the US House of Representatives. Amongst the many factors motivating this landmark legislation is the concern  that regulatory procedures must keep up to date with innovations in clinical development. Cures2015 aims to reform the regulation of drugs, biologics and medical devices while increasing patient access to safe and effective drugs across therapeutic areas.

21st Century Cures presented a draft bill in January 2015 that would affect several regulatory procedures at agencies like the FDA. Included in the various proposals are reforms to the regulation of adaptive clinical trials and the use of Bayesian methods, and expedited approval processes for breakthrough therapies and medical devices. The landmark legislation also incentives improvements to Phase 2 trial design for certain therapeutic areas.   

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Topics: Bayesian Methods, Regulation, Medical Devices, Adaptive Clinical Trials


Adaptive Design and Bayesian Statistics: 5 Years Later (Podcast)

Posted by Esha Senchaudhuri

Jan 29, 2015 4:00:00 PM

February 2015 marks the five year anniversary of the FDA’s Guidance on Adaptive Design Clinical Trials for Drug and Biologics, as well as the FDA’s Guidance on the Use of Bayesian Statistics in Medical Device Clinical Trials. In honor of the five year anniversary of both sets of guidance, the DIA will hold a special joint conference between its Adaptive Design working group and its working group on Bayesian Statistics.

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Topics: Bayesian Methods, 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 an interim look; or preparing different dosages if certain arms of a multi-arm trial are to drop after the interim look. In the case of a biomarker-driven adaptive design, determining adequate drug supply may require the ability to predict which doses are necessary for different subpopulations at particular trial sites.

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


A Bayesian Industry Approach to Phase I Combination Trials in Oncology

Posted by Esha Senchaudhuri

Nov 18, 2014 4:32:00 PM

Statisticians and scientists at Novartis have been at the forefront of developing a new method in early phase oncology trials called the BLRM. Many believe that the BLRM, (short for the Bayesian Logistic Regression Method,) allows for the construction of clinical trials that have the dual benefit of improving treatment for patients participating in the trials, and allowing the trial to complete in a more timely and efficient manner. 

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Topics: Dose-Escalation, Bayesian Methods, Phase 1, Early Phase Trials


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