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

Webinar: Synthetic and External Controls in Clinical Trials

June 22, 2020

Cytel scientists recently published a new eBook on synthetic control arms and a new scientific primer for the more technically advanced. Our new primer focuses on assessing the validity of data, the validity of methodology, and the modes of analysis and interpretation within this burgeoning field. Each of these is a crucial part of understanding how to make the most impact with a synthetic control. Read our blog to learn more about the eBook and the primer, and register to download both.

Cytel also conducted a webinar on Synthetic and External Controls in Clinical Trials with Dr. Kristian Thorlund, a Professor of Biostatistics at McMaster University and Senior Vice President of Real World Evidence at Cytel. In this webinar, Dr. Thorlund introduces synthetic control arms and discusses the validity of data, results and interpretations. He also answers several questions from the audience around sample size calculations, quality of datasets and use of synthetic controls in various kinds of clinical trials. Click on the button to get free access to the recording and the slides from the webinar.

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New Primer and Ebook on Synthetic Control Arms

June 8, 2020

Cytel has recently published a new ebook on synthetic control arms, and a new scientific primer as well.

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Innovations in Oncology Trial Design & Development Webinar Series

May 12, 2020

In our previous blog, “Remote Working Arrangement – How to get it right?”, we talked about how the need for social distancing has led most of the employers, across the globe, to make work-from-home arrangements for their employees. As we continue to stay indoors and combat COVID-19, keeping aside some time every day to read and watch useful resources on important industry topics can be very helpful. Cytel's team of oncology trial design and advanced analytics experts have been hosting a series of complimentary webinars covering a range of innovative topics including adaptive design, machine learning, estimands and trial design software. In this post, we offer you a recap of the webinars we conducted in the past few weeks. You can register for the upcoming webinars in our oncology series by clicking on the button below.

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COVID-19: Trials, Designs and Tools for Promising Results - A Virtual Panel Discussion

May 7, 2020

An extraordinary amount of global research is underway as the COVID-19 pandemic continues to evolve and spread throughout the world. There are over 800 registered global clinical trials taking place to develop life-saving treatments and vaccines for patients. The World Health Organization is also facilitating collaboration and accelerated efforts on an unprecedented scale. In these difficult times, sponsors must utilize innovative tools and approaches to design their clinical trials in order to provide promising results for all patient populations as quickly and efficiently as possible. 

A successful virtual panel discussion was conducted by Cytel on the ongoing COVID-19 Trials, on April 15. For the second complimentary virtual panel discussion held on April 23, Cytel partnered with Certara, to present, “COVID-19: Trials, Designs and Tools for Promising Results”. It began with challenges faced by clinicians and drug developers, followed by examples of tools and trial designs currently being used to help sponsors of COVID-19 trials. Continue reading for a summary of the panel discussion.

Get free access to COVID-19 Panel slides and recording.

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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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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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Is your data strategy set up to tackle key challenges in early clinical development?

February 6, 2020

In clinical development, a high-quality evidence package is a prerequisite for a new therapy to gain approval from regulators and other key decision-makers. As such, the quality of your clinical data is one of the key factors determining whether an effective new therapy reaches patients.

Implementing a data strategy can help to protect the quality of your evidence package. However, many companies start planning their strategy quite late in the development process, which makes it difficult to address (sufficiently address) the complex considerations involved. As we explore in our new eBook, a data strategy planned well in advance of starting Phase 1 and following the industry’s best practices can help you reduce risk, expedite clinical development, and successfully achieve your business objectives.

Download the new eBook, “Are you Harnessing the Power of your Clinical Data?” to find out how to optimize your data strategy to advance clinical development.

download ebookIn our previous blog, we talked about the value of planning a data strategy for the entire duration of your program (i.e., a ‘program-wide’ strategy). However, it is also important to plan for specific phases of clinical development, because they each have unique challenges. Below we discuss the major challenges commonly encountered in Phase 1 and Phase 2 studies, and the tactics you can use to resolve them. An upcoming article will engage with challenges in Phase 3 and post-market.

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Designing Event-based Studies: Interview with Pantelis Vlachos

January 30, 2020

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.

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What could you accomplish with a fresh approach to your clinical data strategy?

January 22, 2020

In the quest for clinical success, we all strive for evidence packages of the highest quality. If the clinical data is strong, then a promising new therapy is more likely to obtain approval from key stakeholders, such as regulators and payers . As a result, you’ll get the chance to develop a therapy that will help many patients (and you will likely gain returns on your investments). As we discuss in our new eBook on data strategy planning, a carefully planned data strategy can help mitigate risks to your programs and enable you to successfully achieve your goals.

Discover how to plan a data strategy that enhances your clinical programs and enables new therapies to reach patients in our new eBook.

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In the high-stakes environment of clinical development, it is never too early to start protecting your valuable data assets with a first-rate strategy. So, keep reading to learn which planning approach to use, who should be involved, when it is best to start, and why it is well worth going to all the effort.

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