Case Study: Seamless Independent Data Monitoring Committee Support

Posted by Cytel

Jul 19, 2017 9:00:13 AM

With adaptive and innovative trial designs on the rise, operational implementation of interim analyses, including management of Independent Data Monitoring Committees is increasingly important.  In this blog, we will share a case study of how Cytel provided a client with seamless Independent Data Monitoring Committee support encompassing committee selection and management, independent...

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Topics: biostatistics, Clinical Research Services, Statistical Programming, Interim Analyses, ACES, DMC


Creating Data Visualizations with R and Shiny

Posted by Cytel

Jul 13, 2017 5:25:00 AM

By Tejasweeni Rajput

It’s been known for centuries that a picture can tell a thousand words. In an era of new technologies, and increasing volume of information, visualizations can help us to express complex data simply and effectively. Advanced technology is now available that allows statisticians and data scientists to drill down into the data sets to be analysed, and develop dynamic...

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Topics: biostatistics, Statistical Programming, Clinical Research Services, R programming


Collaboration Brings Success for the UK Adaptive Designs Working Group.

Posted by Cytel

Jul 11, 2017 6:57:00 AM

The Adaptive Designs and Multiple Testing Procedures Workshop (ADMTP), the first joint meeting of the Adaptive Designs Working Group of the MRC Hubs for Trials Methodology Research and the joint ADMTP Working Group of the International Biometrics Society German and Austro-Swiss Regions, took place in Cambridge, UK last month. 

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Topics: biostatistics, adaptive designs, Clinical Data, Adaptive Clinical Trials


When Biostatisticians Disagree About Ethics

Posted by Cytel

Jul 6, 2017 9:09:00 AM

 By Esha Senchaudhuri

The ethical benefits of adaptive clinical trials have been widely acclaimed: higher prospects for patients to be enrolled into the correct trial arm [1]; shorter trials for the most effective new therapies (see the early stopping outcome of the MUSEC trial) [2]; and enrollments commensurate with the needs of research, i.e. the last patient enrolled is not superfluous to a...

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Topics: biostatistics, Regulation, patient enrollment, Adaptive Clinical Trials, medical ethics


Under wraps: the importance of patient privacy

Posted by Manjusha Gode

Jun 28, 2017 4:36:40 AM

About the Author: Manjusha Gode has over 28 years' IT experience spanning delivery Management, quality management, software testing,  people management, process improvement and multi-locational operations.  She is a pioneering member of Cytel's clinical programming team.

 Clinical data transparency improves decisions for all healthcare stakeholders including patients, caregivers, healthcare...

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Topics: biostatistics, Statistical Programming, Clinical Research Services, CDISC, Regulation


Join us for the East Symposium and User Group Meeting

Posted by Cytel

Jun 26, 2017 8:28:03 AM

Since 2011 we have been celebrating Cytel's birthdays by holding an East Annual Symposium and User Group Meeting ( EUGM), alternating locations between Europe and the United States. Our keynote speakers have featured some of the industry's most eminent biostatistics thought leaders including Stuart Pocock, Dave DeMets, Chris Jennison, Sue Todd, and Franz Koenig.  Each annual event has been a...

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Topics: biostatistics, adaptive designs, Adaptive Clinical Trials, East, EAST 6.4, Dose-Escalation, Multi-Arm Multi-Stage Studies


Cytel ASCO 2017 Report

Posted by Cytel

Jun 20, 2017 7:17:47 AM

 At ASCO 2017, Cytel trial design experts joined our medical and academic colleagues to share the most recent innovations in cancer research.In this blog we will share the abstract and pdf of the poster presentation: TAPPAS: Adaptive enrichment phase 3 trial of TRC105 and pazopanib versus pazopanib alone in patients with advanced angiosarcoma (AAS), co-authored by Cytel's Cyrus Mehta and...

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


Poster: Model Based Predictions of Pharmacodynamic Responses in Ulcerative Colitis Patients

Posted by Cytel

Jun 12, 2017 12:30:00 PM

The Population Approach Group in Europe (PAGE) represents a community with a shared interest in data analysis using the population approach. Each June, a meeting of the community is held at a different European location. At this year's meeting in Budapest, Hungary, Cytel's Director of Quantitative Pharmacology and Pharmacometrics, Cecilia Fosser, showcased innovative work on creating model...

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Topics: biostatistics, Statistical Analysis, pharmacometrics, pharmacology, Simulations


Measuring Intergroup Agreement and Disagreement

Posted by Cytel

Jun 8, 2017 9:50:07 AM

 

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. 

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


Highlights from the PSI 2017 Conference

Posted by Cytel

Jun 1, 2017 8:06:00 AM

A number of the Cytel team were in London, 14th – 17th May 2017 for the PSI Annual conference. The PSI Conference is an important forum for statisticians and we found this year's event insightful, informative and well attended. In this blog, we'll summarize some of the particular highlights from the sessions that our team members attended.

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Topics: biostatistics, adaptive designs, PSI Conference, Clinical Data, Adaptive Clinical Trials


Interview: How can a Bayesian framework support benefit risk assessment?

Posted by Cytel

May 30, 2017 8:06:00 AM

A recent paper The case for Bayesian methods in benefit-risk assessment: Overview and future directions (1)  co-authored by Cytel Senior Vice President Consulting  Yannis Jemiai and published in Therapeutic Innovation and Regulatory Science, tackles the critical issue of benefit risk assessment, and the part Bayesian approaches can play in resolving their challenges.

There is certainly an...

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Topics: biostatistics, benefit risk assessment, Statistical Analysis, Bayesian Methods, Bayesian


Cytel statistical programmer gains recognition at PharmaSUG 2017

Posted by Cytel

May 26, 2017 12:25:00 PM

PharmaSUG 2017 proved to be an inspirational and informative event. With over 200 paper presentations, posters, and hands-on workshops to choose from, delegates could select the topics most relevant to their statistical programming experience and interests.

PharmaSUG papers are split into 15 different academic sections, and Cytel was well represented in the Statistics and Pharmacokinetics...

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Topics: biostatistics, Statistical Programming, SAS, careers


Jim Bolognese named 2017 American Statistical Association Fellow

Posted by Cytel

May 22, 2017 9:00:00 AM

James (Jim) Bolognese, Senior Director, Strategic Consulting, Clinical Services at Cytel Inc. was named a 2017 fellow of the American Statistical Association (ASA). Jim will be officially honored by the ASA at the Joint Statistical Meetings in Baltimore, Maryland this summer.

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Topics: biostatistics, Adaptive Clinical Trials, adaptive designs, Interim Analyses, Cytel Strategic Consulting, Statistical Analysis, Clinical Development Strategy


Case Study: From Trial Design to CDISC Submission

Posted by Cytel

May 17, 2017 7:22:51 AM

This new case study shares how Cytel supported a specialist biopharmaceutical company from Phase 2 trial design through to an FDA submission for their lead product candidate. We assembled an expert multidisclipinary team of data coding specialists, biostatisticians, statistical programmers and medical writers to support a number of the studies in the ongoing program, including pivotal Phase 2b...

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Topics: biostatistics, Case Study, Statistical Programming, CDISC


The Insider View: PSI 2017 Conference Preview

Posted by Cytel

May 10, 2017 5:48:04 AM

PSI is a global member organization dedicated to leading and promoting best practice and industry initiatives for statisticians in the biopharmaceutical industry.  2017 marks a significant milestone for the organization's PSI conference as it hits its 40th year of promoting statistical insight. This is reflected in its status as the key event on the calendar for statisticians in the...

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


In the Midst of this: The Data Management Perspective on the Interim Analysis

Posted by Cytel

May 4, 2017 9:07:00 AM

 As a recognized expert in adaptive trials, Cytel has extensive experience designing and managing trials with interim analyses.  To ensure success in what are often complex studies, data management as well as statistical expertise is required.  Cytel data managers are well versed in the various nuances and demands of managing the successful delivery of an interim analysis from a data...

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Topics: Data Management, Interim Analyses, EDC


Case Study: Redesigning a Pragmatic Trial in Oncology

Posted by Cytel

Apr 28, 2017 9:42:44 AM

In this blog we share a case study in which our statistical consulting team helped a client redesign an oncology pragmatic trial to address regulatory agency questions.

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Topics: biostatistics, real world evidence, Oncology, Regulation


Critical Operational Considerations for Interim Analyses

Posted by Cytel

Apr 25, 2017 6:24:00 AM

At a recent conference Adam Hamm, Director Biostatistics at Cytel, presented his thoughts on Best Practices and Operational Considerations for Adaptive Designs and Interim Analyses. In this blog, we share some highlights from his presentation, drawing out some of the key operational priorities from the biostatistician's point of view. 

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


Trends in Model-Informed Drug Development: Our ASCPT Takeaways

Posted by Cytel

Apr 19, 2017 5:19:08 AM

The ASCPT is the largest scientific and professional organization serving the disciplines of Clinical Pharmacology and Translational Medicine, and its annual conference is one of the most important events on the calendar for those involved in Quantitative Pharmacology and Pharmacometrics (QPP).  Cecilia Fosser, Nand Kishore Rawat and Tina Checchio represented Cytel’s expanding QPP team at this...

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Topics: biostatistics, pharmacology, Early Phase Trials, pharmacometrics, Phase 3


FDA 22 Case Studies and Mitigating Phase 3 Risks

Posted by Cytel

Apr 11, 2017 10:29:00 AM

In a January 2017 paper (1), the FDA reviewed 22 case studies where promising Phase 2 trials did not result in efficacy, safety or both being confirmed in a Phase 3 trial.

At the outset, the authors of the paper are careful to state that the aim is not to assess why these unexpected results occurred, but rather to demonstrate how different trials contribute to developing our scientific...

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Topics: biostatistics, Adaptive Clinical Trials, adaptive designs, adaptive sample size re-estimation, Phase 3, Clinical Development Strategy


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