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


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


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


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


Maximizing Preclinical Knowledge for Optimal R&D

Posted by Cytel

Apr 3, 2018 2:00:00 PM

 

By Esha Senchaudhuri

In response to its R&D productivity from 2005 – 2010, AstraZeneca took the initiative in 2011 to implement what it has called the 5R Framework to strengthen its capabilities. In a Perspectives article from Nature Reviews Drug Discovery [1], Paul Morgan and his team provided complex details about the success of this framework from the perspective of every stage of drug...

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Topics: Program and Portfolio Optimization, quantitative decision-making, clinical development


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


What's the price of pharma innovation?

Posted by Cytel

Apr 5, 2016 4:00:00 PM

 

 

Cost of pharmaceutical development and R&D productivity is an ongoing industry concern, consistently discussed in the mainstream and specialist press.  The issue is held in delicate balance against the increasing pressure on pharmaceutical pricing and cost containment measures.

A study by Tufts Center for the Study of Drug Development published earlier this year in the Journal of Health...

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Topics: Phase 1, Program and Portfolio Optimization, Phase 3, phase 2, go-no-go, clinical development


How to Shorten a Cardiovascular Outcome Trial By Two Years

Posted by Esha Senchaudhuri

Feb 10, 2015 5:28:00 PM

Cardiovascular outcome trials (CVOTs) have earned the reputation of being the untamable behemoths of the clinical world. Needless to say these trials are long and require extremely large sample-sizes. The Contrave LIGHT study required 8900 patients. The SAVOR TIMI trial enrolled 16,492 patients. Even the EXAMINE trial, which benefited from a promising zone design, required 650 patients. 

However,...

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Topics: Cyrus Mehta, Promising Zone, Cytel Strategic Consulting, Interim Analyses, Program and Portfolio Optimization, Cardiovascular, Clinical Development Strategy


5 Scenarios When ‘Keep it Simple’ May Be Bad Advice for Clinical Trial Designers

Posted by Esha Senchaudhuri

Sep 18, 2014 10:44:00 AM

When designing clinical trials, many trial designers are advised to keep the trial simple. Prima facie, the keep it simple principle seems like sound advice. There are various logistical uncertainties that arise when implementing a clinical trial, and the more simple a trial – so conventional wisdom says – the easier it is to respond to these uncertainties.

According to Zoran Antonijevic, a...

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Topics: Oncology, Promising Zone, sample size re-estimation, Enrichment, Cytel Consulting, Efficacy, Interim Analyses, forecasting, optimization, Program and Portfolio Optimization, R&D, Adaptive Clinical Trials


Impact of Study Design and Development Strategy on Pharmaceutical Programs and Portfolios

Posted by Esha Senchaudhuri

Sep 2, 2014 11:19:00 AM

As more clinical trials make use of adaptive designs, investors have come to realize that high quality trial designs can result in significant improvements to a trial’s financial risk profile. Regardless of a trial’s eventual success or failure, a well-constructed design provides a drug with the highest possible probability of success while mitigating financial risk.

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Topics: Nitin Patel, Cyrus Mehta, Promising Zone, Trial Quality, Cytel Strategic Consulting, Trial Design, Entrepreneurship, Program and Portfolio Optimization, R&D, Adaptive Clinical Trials


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