The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
Since 1953, when the discovery of the structure of DNA was made, we have seen great advancements in genomics. Particularly, in the last few years, the industry has seen a rapid rate of adoption in biomarkers and how they can be used to improve biomedical interventions. Trial investigators have been showing interest in biomarker-guided trials such as basket trials and umbrella trials, developed under the master protocol framework. As a result, we have been seeing a rapid rate of adoption of these innovative trial methods.
In our previous blog, we spoke with Jay Park, Director, Cytel, about the concept of master protocols, their importance and future growth potential. On March 19, Cytel conducted a webinar with Jay on “Key Design Considerations for Basket Trials and Umbrella Trials”. This webinar introduced two master protocol types and explored their extension to design in various contexts from the HIV epidemic in global health to expedited oncology trials. Continue reading for key highlights from the webinar .
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In September 2018, the FDA provided a draft guidance on master protocols reflecting an increased interest in these designs by industry. This came after a 2017 editorial published by the Drs. Woodcock and LaVange from the FDA in the New England Journal of Medicine. In this guidance master protocol is defined as a protocol designed with multiple substudies, which may have different objectives and involves coordinated efforts to evaluate one or more investigational drugs in one or more disease subtypes within the overall trial structure. As the adoption of these innovative trial methods is on the rise, we speak with Jay Park, Director, Cytel, about the concept of master protocols, their importance and future growth potential. We take a closer look at their use in oncology trials where the increase in biomarker driven enrichment and stratification designs, as well as the use of companion diagnostics, ensures that master protocols are often adopted by trial investigators.
It is widely acknowledged among drug developers that one of their most important assets is the data generated during clinical trials. Hence, it is no surprise that many companies plan and execute a strategy to protect the quality of the clinical data they produce. It is, however, easy to underestimate just how much time and expertise you need to address the numerous and complex considerations involved in the planning process.
Unlock top tactics and tips on how to plan a rock-solid data strategy to minimize risk and boost clinical success in our latest eBook.
If you are keen to find out how to optimize your clinical data strategy, read on to discover five of the top tips outlined in our eBook from specialists working in the Strategic Consulting, Clinical Research Services, and Data Management teams. Their global reach ensures top insights from every corner of the world.
The Cytel Trial Design Innovations (CTDI) Webinar Series recently hosted a webinar on designing event-based studies. Such studies are essential to designing high-efficiency clinical trials in certain therapeutic areas, but they add a number of challenges to the already complex landscape of adaptive trials.
The webinar was held on January 23rd, featuring Biostatistician and pioneering Bayesian trial-designer Pantelis Vlachos. We had the opportunity to sit down with Dr. Vlachos and speak about innovative trial designs and their benefits, adaptations and interim looks in oncology and cardiovascular, the challenges of designing event-based studies more generally, and how Cytel’s array of software tools, particularly East®, has enabled trial sponsors to fully consider their options in the design of high-efficiency clinical trials.
January’s Cytel Trial Design Innovations (CTDI) Webinar Series will feature Biostatistician and pioneering Bayesian trial-designer Pantelis Vlachos. Next week, Dr. Vlachos will speak on high-efficiency trial design for Event-Based Studies, particularly in oncology and cardiovascular trials. In this blog post, we offer a glimpse of Dr. Vlachos’ last CTDI Webinar (February 2019) on high-efficiency trial design using enrichment strategies.
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In clinical development, data is the vital ‘foundation’ that supports your programs. To successfully bring a promising new therapy to patients, the quality of your evidence must be strong enough to gain approval from key decision-makers, including regulators, payers, and health technology assessment (HTA) agencies.
So, how can you strengthen the quality of your clinical evidence package? A key solution is to optimize your data strategy. As we discuss in our new eBook on data strategy planning, making just a few small changes to your planning approach can strengthen your ‘foundation’ and generate various benefits that enhance and expedite clinical development.
Download our free eBook to find out how to optimize your data strategy to boost success in clinical development.
Interview with Kannan Natarajan: Drug Development in Rare Diseases - Need for Innovation in Statistical Thinking
Cytel is delighted to have Kannan Natarajan speaking at the “Complex Innovative Trial Design Symposium and East User Training” on November 6 in Boston, MA. We got a chance to sit down with Kannan and talk about his career in statistics, the changing role of statisticians, his views on evolving statistical thinking, estimands and relevance of technology in the context of rare diseases.
In this blog, we talk with Robert Greene, Founder and President of the HungerNDThirst Foundation, about his upcoming presentation at Cytel’s East User Group Meeting on 14th and 15th November at Merck in Darmstadt, Germany. Robert will bring a fresh perspective to the discussion of the role statisticians can play in enhancing the position of patients in clinical trials. Patient-centricity is a key topic in modern drug development, and this session aims to encourage statisticians to question the importance of a more patient-centric approach within their field.
Cytel data scientists apply advanced statistical techniques including predictive modeling of biological processes and drug interactions to unlock the potential of big data.
In this blog we talk to Munshi Imran, who is based in Pune, India to find out more about his career path, current role at Cytel and his interests outside of work.