In this edition of the Career Perspectives series, I interview Malte Stein, Senior Biostatistician. Malte owned the development of an application for Cytel’s Cytemation Initiative that focuses on the development of tools and processes that improve speed, efficiency, and quality. In this interview, Malte talks about his experience of working at Cytel, the focus on integrated project management, and the necessary qualifications to work here as a biostatistician.
Career Perspectives: A Conversation with Nicolas Rouillé
In this edition of the Career Perspectives series, I interview Nicolas Rouille, Senior Director, Statistical Programming. Nicolas played a key role in the development of an internal tool and improvement of processes that impact speed, efficiency, and quality through standardization and automation of Cytel’s Project-Based Services (PBS) and Data Monitoring Committee (DMC) delivery. In this interview, we learn about his professional journey, Cytel’s integrated project management approach, and the necessary qualifications to work with Cytel as a statistical programmer.
(Re)Integration Dilemma: Integrated Summaries of Safety and Effectiveness
As promised in my last post prior to PHUSE-EU Connect, I’d like to now share some reflections on my “Integration Dilemma” speech, in which I discussed integrating data from different studies for supporting, for example, integrated summaries of safety and effectiveness.
An Integrated Summary of Safety (ISS) is required by the U.S. Food and Drug Administration (FDA) as a critical component in any New Drug Application (NDA) or similar market approval request. Read more »
A Data Manager’s Role in Supporting a Rare Disease Clinical Study
It is a common perception that the role of a Data Manager is only to perform what we call “Data Cleaning”; making sure the data is consistent and in line with the protocol by sending, answering, and closing queries (questions sent to the site through the system). However, a data manager’s role is more than that and it starts soon after the final version of the protocol is released and is available. From building the eCRF to the end of the study lock, a data manager must anticipate, decide, coordinate and control.
A Preview of Cytel’s Contributions to PHUSE EU 2022
Although many of you can’t wait for the start of the Football World Cup 2022 (in less than two weeks while I’m writing this post), I’m counting the days until the next PHUSE EU Connect 2022 (less than a week away). Believe it or not, this is not simply because my team didn’t qualify (once again, guess which team?), but PHUSE EU Connect 2022 will be my first live conference after about three years since the start of the pandemic, and this is likely the same for many of the attendees.
Adaptive Designs are Re-Defining Drug Development – Learn What’s New
Written by Jing Ping Yeo and Charles Warne
Adaptive designs are studies that “include a prospectively planned opportunity for modification of one or more specified aspects of the study design and hypotheses based on analysis of data (usually interim data) from subjects in the study, “1 with the aim to provide an opportunity to gather more complete information about the therapeutic intervention from interim analyses. This lessens the unpredictability and reduces the risk of failure of Phase III confirmatory trials due to safety and efficacy concerns. In a traditional fixed-trial approach, the trial is designed and conducted as prescribed by the design until the end of the study when the final data are analyzed. Phases of clinical research are conducted as sequential, stand-alone studies from first-in-human Phase I dose escalation, to Phase II dose-finding, until final Phase III confirmatory trials leading to marketing approval. In adaptive trials, scheduled interim analyses are performed to learn from the accumulating data and make necessary modifications while the trial is ongoing, maintaining the study’s integrity and the validity of final conclusions. The most frequently appearing types of adaptations are seamless Phase II/III (57%), group sequential (21%), biomarker adaptive (20%), and adaptive dose-finding designs (16%).
In a recent DIA-Singapore conference presentation, Cytel biostatistician Charles Warne further elaborated on the three types: