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 22, 2017 9:00:00 AM
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...
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...
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...
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.
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.
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...
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...
Apr 5, 2017 11:39:42 AM
Statistical programmers at all levels can make a significant impact on streamlining delivery, improving efficiency, and importantly ensuring quality. At a recent PhUSE Single Day event , Cytel's Sunil Gupta gave a very well received presentation on how best to achieve high quality deliverables while maintaining efficiency, noting that 3 key components should be observed:
Mar 29, 2017 8:29:00 AM
With an increasing interest in platform designs and other innovative designs that involve multiple comparisons over multiple stages, the importance of Multi-Arm Multi-Stage ( MAMS) designs is set to rise.
Mar 24, 2017 9:27:00 AM
Robust go/no-go (GNG) decision-making is essential for effectively managing risk across a clinical portfolio. In early phase development, it is particularly important to have the correct tools in place to terminate ineffective compounds quickly, while accelerating promising ones through the process.
Mar 15, 2017 8:51:00 AM
A precise and thorough approach to planning is key for success in data management.
The Data Management Plan (DMP) is a critical document in any data management project. It outlines all of the data management work to be done, the timelines and milestones to be achieved, as well as the outputs to be produced. The DMP lets all of the stakeholders know what to expect, how to expect it and when...
Mar 10, 2017 7:19:33 AM
At the recent Biosimilars Summit in Philadelphia, Cytel's Pantelis Vlachos presented on statistical challenges and flexible approaches in biosimilar development. In this blog we summarize some of the challenges and share the slides from talk.
Mar 2, 2017 8:45:00 AM
We continue our case study series with this example of a Phase 3 design that uses Bayesian decision making combined with frequentist final analysis.
Clinical Development Background
Our biopharmaceutical client’s lead drug candidate is a late clinical-stage cancer immunotherapy for treatment of a rare oncology indication. Clinical development of therapies in this indication faces inherent...
Feb 27, 2017 7:39:00 AM
It’s been hard to miss the prevalence of estimand-related discussions in the last year. This is a topic which is very much at the forefront of statistics discussions right now. We are lucky enough to welcome Mouna Akacha to the blog to give us the lowdown on estimands and the problems and opportunities they represent for the global biopharma industry.
Mouna is a Consultant in the...
Feb 21, 2017 9:39:07 AM
In a previous blog, we provided an overview of basic data structures in R. In this follow up piece, we will provide a snapshot of basic syntax in R for programmers who want to get up to speed in this increasingly important programming language.
Feb 15, 2017 9:33:05 AM
Outsourcing solutions should never be a one size fits all process, and smaller and emerging biopharma companies may have different priorities and processes when working with external vendors to larger pharmaceutical organizations.
Feb 6, 2017 9:10:00 AM
CDISC is a global, nonprofit charitable organization whose mission is ‘to inform patient care and safety through higher quality medical research’. The organization delivers this mission through the development of data standards designed to streamline clinical research- these standard formats are increasingly expected for use in data submissions by regulatory authorities. Importantly, data...
Jan 30, 2017 9:50:24 AM
Single ascending dose (SAD) and multiple ascending dose (MAD) studies are typically the first in human studies. They seek to gain information on safety and tolerability, general pharmacokinetic (PK) and pharmacodynamic ( PD) characteristics, and of course identify the maximum tolerated dose (MTD).
Conventionally, SAD and MAD studies were conducted separately, but increasingly are combined...
Jan 23, 2017 10:35:00 AM
As a group, Cytel had over 40 successful regulatory interactions last year, many of which supported approvals for innovative trial design approaches. In this blog we look at some of the key success factors for regulatory interactions regarding adaptive designs.