A 2018 publication in the  Biometrical Journal by Cytel’s Cyrus Mehta, Lingyun Liu and Sam Hsiao, ‘Optimal Promising Zone Designs’ (1) marks a new milestone for adaptive sample size re-estimation. Inspired by insights from the team's work with a number of Cytel's strategic consulting clients, it presents an easy to implement and new iteration of the popular promising zone design. The basic...

Topics: adaptive sample size re-estimation, Promising Zone, adaptive trials

QPP remains at the heart of model based drug development. Short for Quantitative Pharmacology & Pharmacometrics, it refers to several types of quantitative modeling including meta-analysis, PK/PD, statistical modeling and the modeling of go-no-go decision rules. Cytel’s expert Quantitative Pharmacology and Pharmacometrics group delivers high quality solutions to help our customers get those...

Topics: Clinical Research Services, Statistical Analysis, careers, clinical data management, clinical research, Data Management, Statistical Programming, quantitative decision-making, model-informed-drug-development, Early Phase Trials, Phase I, pharmacometrics, pharmacology

 

Nand Kishore Rawat is a Director and Head, Early Phase Biostatistics based in the King of Prussia, PA Cytel office. We recently spoke with Nand for the Cytel podcast to gain his thoughts on the unique aspects of Phase 1 development and where innovative approaches supported by thorough planning can meet these challenges head-on.  Read on for key insights or listen to the podcast. 

Topics: clinical research, clinical trials, biostatistics, Cytel Strategic Consulting, clinical development, Phase I, pharmacometrics, quantitative decision-making

Happy New Year! As we look ahead to future successes and the new advancements in drug development that 2019 will bring, we are taking a moment to reflect on the topics that resonated most with our community on the Cytel blog in 2018. While these 6 most popular blogs encompass a variety of topics from across the data science, statistics, and statistical programming space, they all have in...

Topics: clinical research, clinical trials, adaptive trials, feature selection, Clinical Data, CDISC, meta-analysis, data science

PhUSE EU Connect 2018 took place in Germany’s financial capital Frankfurt, 4th - 7th November and brought together a range of experts to tackle the most pressing issues facing statistical programmers today. The agenda was superb with 143 presentations in 16 different streams and nearly 30 posters. This year’s event theme ‘Future Forward’ did not disappoint and there were some very...

Topics: adaptive designs, data science, careers, R programming, Statistical Programming, PhUSE, SDTM, machine learning, CDISC, FDA

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

We are excited to announce an upcoming webinar in our Trial Innovations Series. “Basket Trials: Design and Implementation Considerations” on 4th December 2018 at 11am EST. Noted basket trial expert, Robert (Bob) Beckman will share his most recent experiences with Cytel Strategic Consulting Statistician Sam Hsiao on expanding the application of this innovative breed of trials. Bob acts as a...

Topics: Oncology, basket trials, webinar

 

 Data is the most crucial asset in any clinical trial and is used to ultimately drive the decision-making process related to the development candidate. Therefore, for any sponsor, paying close attention to the data management aspects of clinical operations should be paramount. The principles of data management are simple and well-founded. However, the application of these principles needs...

Topics: Data Management

Cytel biostatisticians Cyrus Mehta and Lingyun Liu, together with Charles Theuer, CEO of TRACON Pharmaceuticals have recently co-authored a publication in the journal Annals of Oncology: “ An Adaptive Population Enrichment Phase 3 Trial of TRC105 and Pazopanib Versus Pazopanib Alone in Patients with Advanced Angiosarcoma (TAPPAS Trial)”. The paper explores the features of this innovative...

Topics: clinical research, clinical trials, Oncology, Precision Medicine, adaptive trials, adaptive designs, adaptive sample size re-estimation, population enrichment

 

Topics: clinical research, clinical trials, clinical development, biostatistics, patientricity

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

In this blog we talk to Munshi Imran, who is based in Pune, India to find out more about his career path, current role at Cytel and his interests outside of work.

Topics: Statistical Analysis, careers, clinical research, Statistical Programming, CRO, Recruitment, Cytel Strategic Consulting, adaptive designs, Adaptive Clinical Trials, clinical trials, Regulation, big data, Trial Design Software, Software Simulations, genetic algorithm

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

The Society for Clinical Data Management (SCDM) conference brought clinical data managers from around the world to Seattle-Bellevue, WA on September 23-26. The conference offered an unmatched opportunity to discover innovative solutions in the clinical data management industry. In this blog, we will share our data management colleagues' experiences, observed trends and contributions to the...

Topics: clinical data management, data manager, Clinical Data, clinical research, clinical trials, clinical development, CDM

Topics: CDISC, SDTM, Data Management, clinical data management

 

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

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.

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

 

The biopharmaceutical and healthcare industries now collect more data than ever before due to advances in the variety of information sources combined with the ability to store vast quantities of diverse data. Sophisticated machine learning (ML) and artificial intelligence (AI) techniques allow us to accessand analyze any combination of a multitude of data sources. The way that traditional...

Topics: biostatistics, data science, real world evidence

 

On August 29th 2018, the FDA announced (1) that it would be establishing a Complex Innovative Trial Design (CID) Pilot Meeting Program. This follows the release earlier in August of a draft guidance (2) to help advance effective and innovative clinical trial designs early in drug development that can expedite new cancer therapies.

Topics: biostatistics, adaptive trials, adaptive sample size re-estimation, Seamless designs, FDA, Oncology

 

EnForeSys is Cytel’s tool for patient recruitment planning. We have discussed on the blog recently with Tufts University's Center for the Study of Drug Development, Ken Getz, the problem the industry continues to face with patient recruitment, and the fact that most trials significantly exceed their original planned duration. In the face of this problem there's a pressing need to create more...

Topics: patient enrollment, enforesys, clinical trials