Can Statisticians Contribute to Enhance the Position of Patients in Clinical Trials?

Posted by Cytel

Nov 12, 2018 8:04:00 AM

 

In this blog, we talk with Robert Greene, Founder and President of the HungerNDThirst Foundation, about his upcoming presentation at Cytel’s East User Group Meeting on 14th and 15th November at Merck in Darmstadt, Germany. Robert will bring a fresh perspective to the discussion of the role statisticians can play in enhancing the position of patients in clinical trials. Patient-centricity is a...

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Topics: Adaptive Clinical Trials, Trial Design, phase 2, Program and Portfolio Optimization, Simulations, East, adaptive designs, Bayesian Methods, Phase I, biostatistics, Statistical Innovations in Clinical Development, randomization, patientricity


Selection Bias for Treatments with Positive Phase 2 Results with Simon Kirby

Posted by Cytel

Oct 18, 2018 11:09:00 AM

 

In this blog, we talk with Simon Kirby, former Senior Director at Pfizer, about his upcoming presentation at Cytel’s East User Group Meeting on 14th and 15th November at Merck Darmstadt, in Germany. Simon will address the topic of Selection Bias for Treatments with Positive Phase 2 Results and in this blog he explains why this is a key topic of particular relevance for pharmaceutical companies...

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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


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


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


Career Perspectives: Interview with Namrata Deshpande, Senior Team Lead

Posted by Cytel

Sep 29, 2017 3:01:00 PM

Namrata Deshpande, Senior Team Lead will be participating in a round table discussion at the Women in Statistics event in California, October 19-21.

This is the first blog in a new 'Career Perspectives' series and we talk to Namrata to find out more on her career path, achievements, current role at Cytel and her interests outside of work. 

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Topics: biostatistics, Clinical Research Services, Clinical Development Strategy, Statistical Innovations in Clinical Development, Statistical Analysis, Statistical Programming, careers, East, R programming


How can Novel Statistical Methods Tackle Antibiotic Resistance? Interview with Scott Evans

Posted by Cytel

Sep 13, 2017 9:00:00 AM

Antibiotic resistance is one of the greatest challenges facing human health today. We are excited to welcome Dr. Scott Evans of the Harvard T.H Chan School of Public Health (HSPH) to the blog to discuss how the novel statistical methods he is developing could help tackle this global crisis.

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Topics: biostatistics, Clinical Research Services, Clinical Development Strategy, Statistical Innovations in Clinical Development, Antibiotic resistance


Design Concept for Basket Trials: Interview with Bob Beckman

Posted by Cytel

Sep 11, 2017 11:25:00 AM

At the East User Group meeting (EUGM) on 25th and 26th October, we will welcome a number of renowned industry speakers to discuss some of the most promising approaches in innovative trial design. Over the next few weeks, we will profile a number of the speakers and their talks. In this blog, we talk with Bob Beckman M.D in advance of his presentation ‘Design Concept for a Confirmatory Basket...

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Topics: biostatistics, Clinical Research Services, Clinical Development Strategy, Statistical Innovations in Clinical Development, East, Oncology, basket trials


Don’t miss these 5 session picks at JSM

Posted by Cytel

Jul 25, 2017 7:37:09 AM

The Joint Statistical Meetings (JSM) is the largest and arguably most highly respected gathering of statisticians in the world.  It will bring together over 6000 statisticians and runs from Saturday, July 29, to Thursday, August 3, 2017. With over 600 sessions,  it can be a challenge to identify the most crucial ones to attend. To help out, we've asked some of the Cytel team for their top...

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Topics: biostatistics, Oncology, Clinical Research Services, Clinical Development Strategy, Adaptive Clinical Trials, Statistical Innovations in Clinical Development, Statistical Analysis, Statistical Programming


It’s Time to Bridge the Gap Between Pharmacometrics and Biostats

Posted by Esha Senchaudhuri

Oct 1, 2015 5:22:00 PM

This week marks the sixth annual American Conference on Pharmacometrics, held this year in Crystal City, VA. Situated at the intersection of mathematical modeling, simulation and big data, the field of pharmacometrics is delivering on its promise to revolutionize clinical research and by extension clinical development.

No wonder then that biostatisticians are now fully engaged with the...

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Topics: Adaptive Clinical Trials, Statistical Innovations in Clinical Development, pharmacometrics


Relative Clinical Efficiency and Phase 2 Biomarker Studies

Posted by Esha Senchaudhuri

Apr 9, 2015 11:37:00 AM

Last year. Nature Reviews Drug Discovery asked the FDA’s Tatiana Prowell (Hematology & Oncology Products Division) about the most common pitfalls confronting clinical trials in oncology. She cited the late stage evaluations of biomarkers as one of three critical issues leading to regulatory failure [1]. The primary lesson: those who want to test biomarkers need to start earlier.  

OncoMed’s Eric...

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Topics: Oncology, Predictive Enrichment, Precision Medicine, Clinical Development Strategy, Statistical Innovations in Clinical Development


Statistical and Operational Challenges of the VALOR Trial: Mehta on the Promising Zone

Posted by Esha Senchaudhuri

Mar 26, 2015 4:00:00 PM

Last year Sunesis completed the VALOR trial, the first clinical study to make use of the groundbreaking promising zone design. The promising zone design implements an unblinded sample re-estimation after an interim look, but only if conditional power during the interim look falls within a designated promising zone. Although the VALOR trial did not confirm the efficacy of the new therapeutic, it...

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Topics: Promising Zone, Statistical Innovations in Clinical Development, Adaptive Clinical Trials


How to Plan Interim Looks in Adaptive Clinical Trials: 3 Strategies

Posted by Esha Senchaudhuri

Mar 19, 2015 5:26:00 PM

A well-timed interim analysis can generally supply added benefits to the operational and administrative aspects of a clinical trial. Particularly when clean data and safety adjudications provide information that is instrumental for stopping a trial early or informing sensitive interim decisions, the timing of an interim look may play a crucial role in leveraging all of the flexibility that a...

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Topics: Interim Analyses, Cardiovascular, Cytel Events, Statistical Innovations in Clinical Development


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