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

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

 

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...

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

 

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...

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

 

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...

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

 

 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...

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

Cytel data scientists apply advanced statistical techniques including predictive modelling of biological processes and drug interactions to unlock the potential of big data.

In this blog from our Career Perspectives series, we talk to Andrea Hita, at Data Scientist at Cytel, to find out more about her career path, her current role at Cytel and her interests outside of work.

Topics: careers, clinical research, CRO, Recruitment, clinical trials, Trial Design, data science, adaptive designs, genetic algorithm, model-informed-drug-development, R language

Cytel has industry-leading experts in Statistical Programming, our programmers have years of SAS® Programming expertise, combined with in-depth knowledge of the specific clinical subject matter, which allows for competent and on-time completion of tasks.

In this blog, we talk to Omar, who is based in Geneva to find out more about his career path, current role at Cytel and his interests outside...

Topics: Statistical Analysis, careers, clinical research, Statistical Programming, CRO, Recruitment, clinical trials, CDISC, Phase 3, Trial Design

We extend our congratulations to Lipopharma and the CLINGLIO project consortium on their recent 6,15M€ grant award by the European Union’s Horizon 2020 program. Led by Lipopharma, the multinational consortium brings together 12 academic and industry organizations from Europe, Israel, and the USA.

Topics: adaptive trials, Oncology, Trial Design, personalized medicine

 

Topics: Statistical Analysis, Trial Design, FMCG

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."

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

 

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,...

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

 

Cytel's Madhusmita Panda presented at this year’s PSI Conference in the Innovative Methodology session on the topic of ‘Measuring Intergroup Agreement and Disagreement’.

In this blog, we share the context, abstract and slides from Panda’s presentation. 

Topics: biostatistics, Interim Analyses, Statistical Analysis, Clinical Development Strategy, Trial Design

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...

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

Fulyzaq® from Napo/Salix was the first drug ever to be approved using an adaptive two-stage "seamless" clinical trial design. However, when Napo Pharmaceuticals sought orphan drug status for Crofelemer (made from the croton lechleri plant, pictured above left), it received a short window from the FDA in which to complete a Phase 3 trial for safety and efficacy. Aiming to diminish both time and...

Topics: Sample Size, Trial Design, Safety, type 1 error, Dose-Finding

Professor LJ Wei holds that rules are for lawyers, not (necessarily) clinicians. When designing modern clinical trials, the impetus is often to use “efficient and reliable procedures, to obtain clinically interpretable results with respect to risk-benefit analysis…” Yet these efficient and reliable procedures are often just conventions and rules that provide information that is incomplete or...

Topics: East, East 6.3, Access to Slides PDF, Trial Design, Trial Monitoring, Training and Education, Predictive Enrichment, Precision Medicine, Translational Statistics, Translational Medicine

Sofia S. Villar is a member of the DART (Design and Analysis of Randomised Trials) group at the MRC Biostatistics Unit in Cambridge England. She has recently been awarded the first Biometrika post-doctoral research fellowship. 

In the post below Villar offers her position on how challenges in rare disease drug development may be alleviated by Bayesian-Bandit adaptive designs. The "Multi-armed...

Topics: Bayesian Methods, Trial Design, Rare Disease

 

The FDA requires sponsors of new antidiabetic drugs to conduct cardiovascular outcome trials (CVOTs). CVOTs demonstrate that new therapies do not place unacceptable cardiovascular risk on patients suffering from Type 2 diabetes. The average CVOT requires about 5000 patients and takes an average of 5 years to complete. However, a recent white paper by the Cardiac Safety Research Consortium...

Topics: Cyrus Mehta, Promising Zone, Trial Design, FDA, Interim Analyses, Cardiovascular, Adaptive Clinical Trials

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.

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

During an invited speakers session at the lnternational Society for Clinical Biostatistics, Cytel VP Yannis Jemiai was joined by R.N. Rodriguez from the SAS Institute and IR White (formerly of Stata), to discuss innovations in software for clinical trials.

Topics: East 6.3, Trial Quality, Trial Design, Entrepreneurship