Last month, Cytel statisticians headed to Baltimore for the Joint Statistical Meetings and shared some of their latest research and insights. In this blog we will summarize our highlights -both from Cytel contributions and the sessions Cytel delegates attended. We also provide access to the valuable slide decks from the Cytel authored presentations.
Aug 15, 2017 7:16:00 AM
Aug 10, 2017 1:18:46 PM
Model-informed drug development has been defined by Richard Lalonde ( Lalonde, 2007) (1) as “Development and application of pharmaco-statistical models of drug efficacy and safety from preclinical and clinical data to improve drug development knowledge management and decision-making”. It has been identified by the FDA as an important way to help reduce attrition and uncertainty in drug development.
In a recent FDA Voice article,(2) FDA Commissioner Scott Gottlieb noted the critical role which modeling and simulation can play in making clinical development more efficient.
He commented that:
“FDA’s Center for Drug Evaluation and Research (CDER) is currently using modeling and simulation to predict clinical outcomes, inform clinical trial designs, support evidence of effectiveness, optimize dosing, predict product safety, and evaluate potential adverse event mechanisms. We’ll be putting out additional, updated guidance on how aspects of these in silico tools can be advanced and incorporated into different aspects of drug development.”
In this blog, we share a new Cytel infographic highlighting 4 key questions a sponsor can explore to apply these approaches within their development programs.
Aug 2, 2017 7:07:00 AM
As a biometrics -focused CRO, Cytel regularly works across a program of studies, providing data consistency, and helping to minimize the oversight burden for the sponsor. In this case study, we describe our work with a client on two Phase 1 studies, and how we were able to carry a number of important efficiencies from the first study to the second.
Jul 26, 2017 10:05:39 AM
Sadly, clinical development of anti-cancer therapeutics faces particularly high rates of failure, even in the context of low success in drug development as a whole. Operating costs for oncology trials are also higher than those observed across the spectrum of clinical development. In a recent article produced for the Pink Sheet ( a leading provider of insights and analysis for biopharma leaders) Cytel's Yannis Jemiai explored the key challenges facing oncology development today, and discussed how adaptive designs can help to improve researchers' probability of success. The article tackles the application of adaptive designs in both exploratory and confirmatory development and the potential benefits to stakeholders, including patients.
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 picks this year.
Topics: Oncology, Clinical Research Services, Statistical Programming, Statistical Analysis, Clinical Development Strategy, Adaptive Clinical Trials, Statistical Innovations in Clinical Development, biostatistics
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 statistical services, and ACES software.
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 graphics that one can interact with. This marks a leap forward in decision-making capabilities from the static figures which have been traditionally available to us.
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.
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 ; shorter trials for the most effective new therapies (see the early stopping outcome of the MUSEC trial) ; and enrollments commensurate with the needs of research, i.e. the last patient enrolled is not superfluous to a trial’s outcomes (e.g. according to one clinical biostatistician, “trial designs that learn more and treat better with less burden and sacrificing of patients”) .
However, the acknowledgement that ethical benefits exist is a separate question from the degree to which they exist when compared to a more traditional design.
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 great success with a mix of scientific presentations, animated discussion, round tables and pre-conference software workshops.
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 Lingyun Liu with TRACON Pharmaceuticals.
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 based predictions of pharmacodynamic responses in ulcerative colitis patients. Fosser presented a poster Model based predictions of the PTG-100 pharmacodynamic responses in ulcerative colitis patients created in collaboration with colleagues from Protagonist Therapeutics.
In this blog we share the abstract and link to access an electronic copy of the poster .
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.
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.
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 industry- wide need for more transparent, targeted and robust benefit risk assessments. In this blog we talk with Yannis about the article and why the Bayesian framework is particularly well suited to these efforts.
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 stream with two of our talented programmers, Chris Smith and Sharmeen Reza, presenting separate papers.
We are delighted to announce that Chris Smith, Senior Statistical Programmer was awarded best paper in his stream. The winning paper Multiple Imputation: a Statistical Programming Story was co-authored with industry colleague Scott Kosten.
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.
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 and 3 trials, and the subsequent creation of the Integrated Summary of Safety (ISS) and Integrated Summary of Effectiveness (ISE).
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 biopharmaceutical industry in Europe and beyond.
With less than a week to go until the 2017 event gets underway in London,14th - 17th May 2017, we chatted with Lucy Rowell, this year’s Conference Chair to get the scoop on the secrets of the conference’s success, this year’s hot topics, and her insider insights into the keynotes and workshops.
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 collection point of view.
Success from the data management standpoint depends on three core elements- effective timeline management, thoughtful database design, and a proactive approach to data cleaning. In this blog, Patti Arsenault, our Global Head of Data Management shares her thoughts.