The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.

Webinar: Key Design Considerations for Basket Trials and Umbrella Trials by Jay Park

March 31, 2020

 

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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Cytel's Response: EMA Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials

March 26, 2020

Further regulatory guidance has been released concerning the implications of the Coronavirus disease (COVID-19) on clinical trials.

 

On March 25th the Biostatistics Working Party (BSWP) of the European Medicines Agency (EMA) Committee for Human Medicinal Products (CHMP) published a draft points to consider guidance document on the actions that sponsors of affected clinical trials should take to help ensure the integrity of their studies, and the interpretation of the study results, while safeguarding the safety of trial participants as a first priority.

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Cytel's Response: EMA Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic

March 23, 2020

On March 20th the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agency (HMA) published new recommendations for sponsors on how to manage the conduct of clinical trials in the context of the COVID-19 pandemic. Extraordinary measures may need to be implemented and trials adjusted due to quarantine, limited access to hospitals, and healthcare professional focus on critical tasks. Here is a review of selected elements of the guidance, interpretations and recommendations.

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Cytel's Response: FDA Guidance on Conduct of Clinical Trials during the COVID-19 Pandemic

March 19, 2020

The FDA issued a guidance yesterday on how the COVID-19 Pandemic may affect the conduct of clinical trials. Below are some key messages from the guidance along with some interpretations and recommendations.

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Interview with Jay Park: The present and future of Master Protocols

March 12, 2020

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.

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Managing risk in clinical development: Is your data strategy fail-safe?

March 5, 2020

Generating high-quality clinical data is a vital but challenging task in modern drug development. Unfortunately, in the current era of ‘big data’ and global clinical operations, spanning multiple sites and digital systems, protecting the quality of clinical data has become harder than ever.

Planning your data strategy is, therefore, crucial to ensure a high-quality evidence package and increase the chances of successful clinical development. However, as we discuss in our new eBook, planning a data strategy is a complex process involving various considerations that require significant amounts of time and expertise to fully address.

Read our eBook for expert insights on planning a data strategy that can help overcome key challenges in clinical development and boost your success.

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In this blog, we discuss the many data-related challenges commonly faced in clinical development and how to implement a fail-safe data strategy that can overcome these challenges, bringing effective new therapies to patients.

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Bayesian Methods for Contending with Homogeneity and Heterogeneity in Real World Data

February 25, 2020

Over the past decade, a new trend began to emerge, changing the way that clinical trials are conducted. Whereas placebo-controlled randomized control

 trials remain the gold standard, in some situations, single arm trials have become an accepted way of assessing a new treatment intervention. Single arm trials establish clinical benefit by demonstrating the positive effects of a new therapy or treatment, without the need to use placebo or standard of care as a control. Instead, alternative approaches of establishing the comparison 
are used; these have become known as external controls or synthetic control arms (SCA henceforth) and include approaches leveraging real world data from various sources or evaluations of historical clinical trial data.   
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Ensuring an Unbiased Comparator Arm

February 25, 2020

Regulators in both the United States and Europe have responded positively to the use of SCAs in clinical development.[1]  While implementation of this method for 

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Drug developers: Unlock the power of your clinical data with these five top tips

February 20, 2020

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.

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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.

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