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

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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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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Adaptive Population Enrichment in a Phase III Oncology Trial

January 16, 2020

 

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.

Don't miss next week's webinar "Designing Event-based Studies: Reduce Sample Size and Increase Predictability"! Click on the button below to register.

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How to optimize your data strategy to drive success in clinical development

January 8, 2020

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.

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Year-End Roundup: Your Favorite Blog Posts of 2019

December 18, 2019

With only two weeks left for this fabulous year to end, we would like to thank all our blog subscribers and new readers for following and appreciating the Cytel blog. This year, we collaborated with several experts from both within and outside the company to bring to you a range of interesting topics including real-world evidence, AI, challenges in rare diseases, patient-reported outcomes, data management, and our popular series “The Good Data Submission Doctor” and “Career Perspectives”. In this blog, we share with you the top 5 Cytel blogs that resonated most with our community in 2019.

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