As part of Cytel's new Trial Innovations Webinar Series, Pat Mitchell, Statistical Science Director at AstraZeneca presented the October webinar "Formal Go/No-Go decisions are a key component of risk management in early clinical development."
Oct 31, 2017 10:42:00 AM
Oct 18, 2017 11:03:00 AM
Cytel's new Trial Innovations Webinar Series provides a platform for the most promising new statistical approaches helping to bridge the gap from methodology to implementation. Ultimately, our goal is to enable our audience to improve their chances of success in clinical development.
The series got underway in August with a webinar on ‘Phase 2 Trial Designs using Program-level Simulations, and Possible Adaptive Approaches’.
Feb 9, 2017 7:34:58 AM
In this blog, Adam Hamm, PhD, Director Biostatistics at Cytel shares some of the most important knowledge he uses in his day to day work as a biostatistician working extensively in oncology research. Adam has broad experience with statistical analysis and methodology over all phases (I-IV) of development, in particular working in the oncology arena.
As a Director of Biostatistics at Cytel, I work on design, statistical analysis and reporting projects for a range of biotechnology and pharmaceutical sponsors. During my career, I’ve developed a particular focus on oncology trials, so in this blog I’ll share some insights into the knowledge which I have found particularly vital as a biostatistician working in this area. This knowledge spans specific statistical methodologies and understanding of the clinical issues across the phases of clinical development. The summary is not exhaustive, but provides a glimpse into the broad exposure which is needed for a biostatistician to develop a fully rounded understanding in the area. To learn more, read on...
Oct 11, 2016 9:31:00 AM
Its important to take a strategic approach to clinical development in order to minimize the potential for Phase 3 attrition. The below infographic, previously published on the blog highlights some of the approvability and economic reasons cited for Phase 3 failure , and the clinical development issues which may have had an impact.
Sep 27, 2016 9:24:00 AM
The Lung-MAP trial is an innovative biomarker driven 'precision medicine' study which evaluates five novel agents for the treatment of patients with advanced squamous cell carcinoma of the lung. As well as exploring therapeutic options for this indication, it also aims to improve the drug development process.
At a Cytel seminar earlier in the year, Antje Hoering of CRAB presented to delegates on some of the practical challenges of the Lung-MAP study.
Sep 9, 2016 9:24:00 AM
Our client, an emerging biotechnology company, was preparing for the next stage of development for their novel compound in a rare disease. They had two major concerns which they wanted the clinical trial design to address- an anticipated difficulty in recruiting subjects to the trial, and the cost and time investment associated with running separate phase 2 and phase 3 trials. They approached Cytel’s strategic consulting team for an innovative solution.
An inferentially seamless Phase 2/ 3 design with promising zone was proposed as a means to address the sponsor’s objectives. Because of uncertainty regarding which dose would be selected and what the effect size of the selected dose would be, the team proposed design options which allowed for adjustment of the sample size using information learned at the interim analysis. Several seamless phase 2/3 designs, with and without adaptive sample size re-estimation were evaluated through simulations using East 6.4.
The simulations evaluated various design parameters such as maximal sample size, timing of the interim analysis, size of the promising zone, and efficacy and futility boundaries. Designs were compared on the basis of overall power, average sample size, conditional power, probability of entering each interim zone, and number of overruns.
The inferentially seamless design has the potential to accelerate clinical development by removing the ‘white space’ between phases 2 and 3. Where the sample size is increased adaptively at the interim analysis by a specified percentage of the original pre-planned sample size, an overall increase in power could also be achieved. The sample size re-estimation design provided a boost to power where the interim results fell in the promising zone. The client benefited from a design which only calls for additional investment of patients and resources when this investment would meaningfully boost the chances of success.
Cytel's statistical consulting team help you decide if an adaptive approach is right for your trial. Read further examples of our work by clicking below.
Jul 18, 2016 8:00:00 AM
In order for adaptive designs to reach their potential, it’s critical that knowledge is effectively dissemirnated within the medical research community – in particular detailed information about the operating and statistical characteristics of specific designs and insights as to their benefits and limitations.
Cytel recently announced the publication of an important article in the New England Journal of Medicine which takes a leap forward in promoting better understanding of adaptive designs particularly in a confirmatory setting. We'll discuss some of the highlights of the article in this blog.
Apr 26, 2016 11:30:00 AM
In this blog we’ll highlight some unique challenges that are encountered from a Data Management perspective when working on early phase Oncology trials. We’ll also discuss approaches which can be employed to mitigate these issues.
Apr 5, 2016 4:00:00 PM
Cost of pharmaceutical development and R&D productivity is an ongoing industry concern, consistently discussed in the mainstream and specialist press. The issue is held in delicate balance against the increasing pressure on pharmaceutical pricing and cost containment measures.
A study by Tufts Center for the Study of Drug Development published earlier this year in the Journal of Health Economics (1) provides new estimates of R&D costs, building on previous work in the area.
Mar 29, 2016 11:00:00 AM
On March 16th and 17th the 5th East User Group Meeting took place in London. This very successful 2 days saw a variety of talks on aspects of clinical trial design innovation. Over the next couple of weeks, we will be reviewing some of the key topics which were addressed during the meeting.
In this post, we'll take a look at Paul Frewer of Astrazeneca's presentation on Decision Making in Early Phase Clinical Development. This talk was very well received by the delegates and prompted plenty of discussion afterwards.
Jul 21, 2015 3:41:00 PM
MCP-Mod methodology for dose-ranging clinical trials has been gaining popularity since the 2013 publication of the qualification opinion by the European Medicines Agency Committee for Medical Products for Human Use. Since its development at Novartis, MCP-Mod promises to devise proof-of-concept and dose-ranging trials which generate superior statistical evidence for dose-selection, while providing safety and efficacy data that can prove critical data for Phase III clinical trial design.
Although the general framework of the MCP-Mod method are becoming more familiar, its added complexity raises the question of whether it is a necessary supplement (or even substitute) for traditional dose-ranging trials. Here are a few shortfalls of the traditional approach that MCP-Mod is equipped to handle.
May 20, 2015 5:56:47 PM
Seamless adaptive clinical trials have gained popularity for reducing the projected time it takes to complete the process of drug development. However, a study by Cuffe et al., shows that despite a tremendous amount of statistical knowledge about seamless trials, sponsors remain unsure about how to calculate the financial and operational costs of a seamless clinical development program . This in turn results in many unnecessary risks and missed opportunities. This post offers advice on what you need to keep in mind in order to implement a successful seamless adaptive clinical study.