Interview with Stephen Senn: 70 Years and Still Here: The Randomized Clinical Trial and its Critics

Posted by Cytel

Oct 5, 2018 7:00:00 AM

 

We are delighted that Stephen Senn will be joining us at the EUGM on November 14th and 15th in Darmstadt, Germany. In this blog, we sit down for a discussion with Stephen about his career in statistics, his advice for early career statisticians, his upcoming research, and the topic of his presentation at the East User Group Meeting “70 Years Old and Still Here: the Randomized Clinical Trial...

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Topics: Adaptive Clinical Trials, Trial Design, phase 2, Program and Portfolio Optimization, Simulations, East, adaptive designs, Bayesian Methods, Phase I, go-no-go, biostatistics, Statistical Innovations in Clinical Development, randomization


Decision Making in Development Programs with Targeted Therapies: with Heiko Götte

Posted by Cytel

Sep 27, 2018 9:00:00 AM

 

In this blog, we talk with Heiko Götte, Senior Expert Biostatistician at Merck about his upcoming presentation at Cytel’s East User Group Meeting on 14th and 15th November at Merck Darmstadt, in Germany. The topic Heiko will address is Decision Making in Development Programs with Targeted Therapies and he explains to us why this is a key topic for pharmaceutical companies today as they...

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Topics: Adaptive Clinical Trials, Trial Design, phase 2, Program and Portfolio Optimization, Simulations, East, adaptive designs, Bayesian Methods, Phase I, Biomarkers, go-no-go


Career Perspectives: Interview with Adam Hamm, Director of Biostatistics

Posted by Cytel

Sep 20, 2018 1:04:00 PM

At Cytel we believe that expert statistical input has the power to shape the future of clinical development: de-risking portfolios, accelerating timelines, and increasing the probability of success.

In this blog we talk to Adam who lives in North Carolina United States to find out more about his career path, achievements, current role at Cytel and his interests outside of work.

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Topics: Statistical Analysis, careers, clinical research, Statistical Programming, CRO, Recruitment, Cytel Strategic Consulting, biostatistics, adaptive designs, Adaptive Clinical Trials, clinical trials, Regulation


Career Perspectives: Interview with Meredith Alm, Manager, QA Compliance

Posted by Cytel

Aug 23, 2018 9:11:00 AM

Cytel has grown significantly over the last 30 years, with operations across North America, Europe, and India. All of our processes, talent, and expertise are applied to maximizing the value of clinical data. At Cytel, quality comes first, and our QA team are committed to ensuring processes are in place to support our services.

In this blog we talk to Meredith who lives in Somerville,...

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Topics: Statistical Analysis, careers, clinical research, Statistical Programming, CRO, Recruitment, Cytel Strategic Consulting, biostatistics, adaptive designs, Adaptive Clinical Trials, clinical trials, Regulation, Trial Quality


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...

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


Career Perspectives: Interview with Sam Hsiao, Associate Director, Strategic Consulting

Posted by Cytel

Jul 24, 2018 6:29:00 AM

At Cytel our strategic consulting team works on a wide range of projects including: Identifying the best clinical trial design, implementing adaptive designs, developing a regulatory strategy and interacting with regulators.

In this blog we talk to Sam who lives in the Boston area, to find out more about his career path, current role at Cytel, industry experience and his interests outside of...

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Topics: Statistical Analysis, careers, clinical research, Statistical Programming, CRO, Recruitment, Cytel Strategic Consulting, biostatistics, adaptive designs, Adaptive Clinical Trials, clinical trials


Unveiling New East 6.5 Modules: Join Our Webinar

Posted by Cytel

Jul 3, 2018 4:15:47 AM

 

 It’s shaping up to be a busy year for Cytel’s software development team with a number of upgrades and planned launches across our range of tools. (Watch this space for announcements soon on new quantitative decision-making software OK GO and an upgrade to EnForeSys). East, our industry leading platform for clinical trial design, simulation, and monitoring will be unveiling version 6.5 in...

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


Highlights from the PSI 2018 Conference

Posted by Cytel

Jul 2, 2018 10:00:00 AM

A number of the Cytel team were in Amsterdam, 3rd- 6th June 2018 for the PSI Conference. This year’s conference was held at the magnificent Beurs Van Berlage, a venue full of history and interesting architectural features. We took the opportunity to give delegates a first look at OK GO, our new clinical trial Go/No-Go decision-making software in this magnificent setting.

In this blog, we'll...

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Topics: biostatistics, adaptive designs, PSI Conference, Clinical Data, Adaptive Clinical Trials, data science, estimands, Bayesian


Addressing Critical Unmet Oncology Needs in the Era of Precision Medicine

Posted by Cytel

May 23, 2018 12:21:00 PM

 

 

Our Industry Voices series showcases our clients’ innovative work and breakthrough therapeutics in oncologic indications and other critical areas of medical unmet need.

In this article, we sit down with Charles Theuer, M.D., CEO of TRACON Pharmaceuticals to discusshis work, his views on the key advancements in oncology development, the unmet needs yet to be overcome, and the importance of...

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Topics: biostatistics, Oncology, Phase 1, Phase 3, Clinical Development Strategy, Adaptive Clinical Trials


Rewriting the oncology textbook with cell-based immunotherapies

Posted by Cytel

May 16, 2018 11:00:00 AM

 

Our Industry Voices series showcases our clients’ innovative work and breakthrough therapeutics in oncologic indications and other critical areas of medical unmet need.

In this article, we are delighted to share an interview with Kurt Gunter, M.D., Chief Medical Officer of Cell Medica in which he discusses his work, his views on the key advancements in oncology development, the unmet needs...

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Topics: biostatistics, Oncology, Phase 1, Phase 3, Clinical Development Strategy, Adaptive Clinical Trials


Innovative Oncology Trial Designs in Practice

Posted by Cytel

May 9, 2018 10:22:00 AM

As we prepare to head to ASCO in under a month's time, we are pleased to share a new ebook that showcases some key applications of innovative trial designs in the oncology development space.

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Topics: biostatistics, Oncology, Phase 1, Phase 3, Clinical Development Strategy, Adaptive Clinical Trials


Interview: Insight into the Coordination of Rare Diseases at Sanford (CoRDS) registry 

Posted by Cytel

Feb 28, 2018 9:02:00 AM

There is a consensus in the industry that data on rare diseases is limited, incomplete, and difficult to find or access. Recently we came across the CoRDS patient registry based at Sanford University and learned that the registry is an effective tool used to gather information useful to researchers studying rare diseases.

We sat down with Benjamin Forred, Project Manager, and Austin Letcher,...

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Topics: Rare Disease, CRO, clinical research, Adaptive Clinical Trials, Clinical Data, real world evidence


Career Perspectives: Interview with Ursula Garczarek, Associate Director - Strategic Consulting

Posted by Cytel

Feb 13, 2018 9:00:00 AM

Our strategic consulting team work on projects such as: Identifying the best clinical trial design, implementing adaptive designs, developing a regulatory strategy and interacting with regulators.

In this blog we talk to Ursula who is based in Germany, to find out more about her career path, achievements, current role at Cytel and her interests outside of work. 

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Topics: Statistical Analysis, careers, clinical research, Statistical Programming, CRO, Recruitment, Cytel Strategic Consulting, biostatistics, adaptive designs, Adaptive Clinical Trials, clinical trials


6 Innovative Trial Design Videos

Posted by Cytel

Jan 26, 2018 9:03:00 AM

The  Cytel YouTube Channel hosts a wealth of video presentations from Cytel experts as well as external industry and academic speakers about various aspects of clinical trial designs and their implementation.  In this blog, we've gathered 6 popular resources from the channel on topics from quantitative decision-making through to overcoming challenges in management of oncology trials. Read on...

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Topics: biostatistics, Adaptive Clinical Trials, adaptive designs, Multi-Arm Multi-Stage Studies, Multi-Arm Studies, EAST 6.4, East PREDICT, pharmacometrics, model-informed-drug-development, Cytel Videos


Slides: East User Group Meeting and Trial Design Symposium

Posted by Cytel

Dec 4, 2017 11:28:00 AM

In 2011, Cytel organized its first East User Group Meeting (EUGM) in Paris. Since then, we have held an EUGM almost every year, alternating between locations in Europe and North America.  These meetings have been a great success, giving opportunities for customers and industry colleagues to meet each other as well as with key opinion leaders, whilst learning more about our East software and...

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Topics: EAST 6.4, Adaptive Clinical Trials, adaptive trials, Statistical Innovations in Clinical Development, Clinical Development Strategy, Cytel Strategic Consulting


Webinar Replay: Dual Target Methods for Go/No-Go Decision Making

Posted by Cytel

Oct 31, 2017 10:42:00 AM

As part of Cytel's new Trial Innovations Webinar Series, Pat Mitchell, Statistical Science Director at AstraZeneca presented the October webinar "Formal Go/No-Go decisions are a key component of risk management in early clinical development."

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Topics: Adaptive Clinical Trials, Trial Design, phase 2, Bayesian, adaptive designs, clinical development, go-no-go, custom software


2017 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop

Posted by Cytel

Oct 24, 2017 6:01:00 AM

The ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop is sponsored by the ASA Biopharmaceutical Section in cooperation with the FDA Statistical Association. Each year 800 statistical practitioners come together to absorb new information on statistical practices in all areas regulated by the FDA.

Cytel was honored to be involved in the workshop program, and our subject...

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Topics: Clinical Data, Clinical Research Services, Adaptive Clinical Trials, adaptive designs, Sample Size, adaptive sample size re-estimation, Bayesian, Regulation, FDA, Promising Zone


Webinar Replay: Phase 2 Trial Designs using Program-level Simulations

Posted by Cytel

Oct 18, 2017 11:03:00 AM

 

Cytel's new Trial Innovations Webinar Series provides a platform for the most promising new statistical approaches helping to bridge the gap from methodology to implementation. Ultimately, our goal is to enable our audience to improve their chances of success in clinical development.

The series got underway in August with a webinar on ‘Phase 2 Trial Designs using Program-level Simulations,...

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Topics: Adaptive Clinical Trials, Trial Design, phase 2, Program and Portfolio Optimization, Simulations


Highlights from the 2017 JSM Program

Posted by Cytel

Aug 15, 2017 7:16:00 AM

Last month, Cytel statisticians headed to Baltimore for the Joint Statistical Meetings and shared some of their latest research and insights.  In this blog we will summarize our highlights -both from Cytel contributions and the sessions Cytel delegates attended. We also provide access to the valuable slide decks from the Cytel authored presentations. 

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Topics: biostatistics, adaptive designs, Adaptive Clinical Trials, Interim Analyses, JSM


Are Adaptive Designs the Answer to Oncology Development Success?

Posted by Cytel

Jul 26, 2017 10:05:39 AM

Sadly, clinical development of anti-cancer therapeutics faces particularly high rates of failure, even in the context of low success in drug development as a whole. Operating costs for oncology trials are also higher than those observed across the spectrum of clinical development.  In a recent article produced for the Pink Sheet ( a leading provider of  insights and analysis for biopharma...

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Topics: biostatistics, Oncology, Phase 1, Phase 3, Clinical Development Strategy, Adaptive Clinical Trials


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