Our recent Clinical Biometrics Survey explored the views of respondents from across the statistical programming, biostatistics, and data management functions to learn their top challenges, and most important perceived industry trends and skills development. In this blog, our Ajay Sathe gives his perspectives on the key areas of personal and knowledge development that he believes statistical programmers need to focus on to keep abreast of the evolving drug development landscape.
Apr 18, 2018 6:09:00 AM
Mar 29, 2018 8:44:00 AM
To mark the occasion of our 30th anniversary, in late 2017 we conducted a brief survey to gain a snapshot of what professionals in data management, statistical programming, and biostatistics feel are the key challenges facing their functions, the top areas for skills development, and the clinical data areas they believe are likely to have the greatest impact on drug development.
We are now able to share our findings- read on for some highlights, and to download your complimentary copy of the report.
Mar 16, 2018 7:00:00 AM
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 Benjamin who lives in France, to find out more about his career path, achievements, current role at Cytel and his interests outside of work.
Topics: Recruitment, Cytel Strategic Consulting, Statistical Programming, Statistical Analysis, clinical development, biostatistics, adaptive designs, adaptive trials, careers, clinical trials, CRO, clinical research
Recent Publication: A Gatekeeping Procedure to Test a Primary and a Secondary Endpoint in a Group Sequential Design with Multiple Interim Looks
Feb 15, 2018 10:35:00 AM
A recent publication in Biometrics ‘A Gatekeeping Procedure to Test a Primary and a Secondary Endpoint in a Group Sequential Design with Multiple Interim Looks’ greatly extends the results of Glimm et al. ( 2010) and Tamhane et al ( 2010) which studied the problem of testing a primary and secondary endpoint, subject to a gatekeeping constraint, using a group sequential design (GSD) with K = 2 looks. This extends the methodology to provide for multiple (K>2) looks. The methodology is applied to the data from the RALES study (Pitt et al., 1999; Wittes et al., 2001).
Feb 13, 2018 9:00:00 AM
Our strategic consulting team work on projects such as: Identifying the best clinical trial design, implementing adaptive designs, developing a regulatory strategy and interacting with regulators.
In this blog we talk to Ursula who is based in Germany, to find out more about her career path, achievements, current role at Cytel and her interests outside of work.
Topics: Recruitment, Cytel Strategic Consulting, Statistical Programming, Statistical Analysis, Adaptive Clinical Trials, biostatistics, adaptive designs, careers, clinical trials, CRO, clinical research
Jan 26, 2018 9:03:00 AM
The Cytel YouTube Channel hosts a wealth of video presentations from Cytel experts as well as external industry and academic speakers about various aspects of clinical trial designs and their implementation. In this blog, we've gathered 6 popular resources from the channel on topics from quantitative decision-making through to overcoming challenges in management of oncology trials. Read on to learn more and access the videos.
Topics: East PREDICT, Cytel Videos, Adaptive Clinical Trials, Multi-Arm Studies, pharmacometrics, Multi-Arm Multi-Stage Studies, biostatistics, EAST 6.4, adaptive designs, model-informed-drug-development
Nov 17, 2017 5:00:00 AM
PhUSE 2017 took place in Scotland’s capital city Edinburgh, 8th - 11th October, and brought together a range of experts to tackle the most pressing issues facing statistical programmers today. We found this year's event informative and well attended. In this blog we share some highlights from the sessions and posters the Cytel team attended. We will share Cytel's own contributions in a separate article.
Nov 9, 2017 11:43:00 AM
In this blog we are excited to unveil a new project which we have been hard at work on over the last few months.
2017 marks a very special milestone for Cytel – our 30th anniversary. Cyrus Mehta and Nitin Patel founded Cytel in 1987 with an initial objective to solve a specific problem in computational statistics.
Nov 6, 2017 5:28:43 AM
At the Chief Medical Officer Summit earlier this year, Cytel's Director of Quantitative Pharmacology and Pharmacometrics Cecilia Fosser, and Senior Director, Business Development, Chuck Gelb presented on how model-informed drug development (MIDD) techniques can improve decision-making and Probability of Success ( PoS) of clinical trial programs. In this blog, we share some highlights and the informative10-minute video replay of their talk which includes a modeling and simulation case study.
Sep 29, 2017 3:01:00 PM
Namrata Deshpande, Senior Team Lead will be participating in a round table discussion at the Women in Statistics event in California, October 19-21.
This is the first blog in a new 'Career Perspectives' series and we talk to Namrata to find out more on her career path, achievements, current role at Cytel and her interests outside of work.
Topics: East, Clinical Research Services, Statistical Programming, Statistical Analysis, Clinical Development Strategy, Statistical Innovations in Clinical Development, biostatistics, R programming, careers
Sep 20, 2017 8:50:19 AM
In this blog we share a case study of work our strategic consulting team conducted supporting accurate event prediction for a cardiovascular outcomes research trial using the Major Adverse Cardiac Events ( MACE) composite endpoint.
Sep 18, 2017 7:38:45 AM
By Ashwini Joshi
For small sample data or rare events data, exact non-parametric tests perform better than asymptotic tests. But they come with the disadvantage of conservativeness. Many corrections have been suggested to reduce this conservativeness but none of them solve the problems entirely. StatXact provides various methods of computing exact p-values. Depending upon the problem at hand, the user can decide which one to use.
Let’s consider a hypothetical example of stratified count data. The example shows two sample data with two strata. Events in Treatment1 are rare as compared to the ones in Treatment0. But the event rates are comparable.
Sep 13, 2017 9:00:00 AM
Antibiotic resistance is one of the greatest challenges facing human health today. We are excited to welcome Dr. Scott Evans of the Harvard T.H Chan School of Public Health (HSPH) to the blog to discuss how the novel statistical methods he is developing could help tackle this global crisis.
Sep 11, 2017 11:25:00 AM
At the East User Group meeting (EUGM) on 25th and 26th October, we will welcome a number of renowned industry speakers to discuss some of the most promising approaches in innovative trial design. Over the next few weeks, we will profile a number of the speakers and their talks. In this blog, we talk with Bob Beckman M.D in advance of his presentation ‘Design Concept for a Confirmatory Basket Trial'. This, the first part of a two-part interview will reveal Bob’s insights into basket trials and their potential. The second part of the blog will delve more deeply into the design concept itself and will be published after the East User Group Meeting. To learn more, read on.
Aug 15, 2017 7:16:00 AM
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 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.