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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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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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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Highlights from PhUSE EU Connect 2019

December 12, 2019

PhUSE EU Connect 2019 was held in the beautiful city of Amsterdam between the 10th and 13th of November. This clinical data science conference comprised 19 Streams, including 150 papers, 24 posters and 3 engaging data scientists as keynote speakers. The event was well attended and had several interesting and innovative presentations. Caroline Terrill, Associate Director of Statistical Programming at Cytel UK, conducted a session “No Place Like Home: Managing Remote Programmers Remotely” and stood out as the winner in the Personnel Management category. Based on 5 years' experience of managing remote programmers, Caroline’s paper gives guidance on issues to be considered and traps to be avoided if you are managing people who work remotely.

In this blog, we share the presentations from our Statistical Programmers and summarize some of the sessions that our team members attended.

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Impact of AI on Clinical Development

December 10, 2019

In association with Statisticians in the Pharmaceutical Industry (PSI) , UCB and Cytel hosted a symposium on September 11, 2019 at UCB’s offices in Slough, Berkshire. The primary agenda was to educate the audience on Artificial Intelligence (AI) approaches and their impact on clinical development.

With recent advances in AI, it is important for quantitative scientists to keep up to date with the most recent methods and be involved in guiding their application to the most pressing analytical challenges. This one-day event covered cutting edge examples of how data science and statistical sciences are intersecting, and its relevance to our attendees.

“Artificial Intelligence and associated methodology is becoming increasingly important to the Pharma Industry and its technical foundation in statistical theory means that PSI is naturally keen to promote good practice through its membership and established Industry links. PSI is proud to have set up a Special Interest Group in this field and is keen to broaden its links and membership.”

- PSI Data Science special interest group

In this blog, we share some of the key takeaways from the symposium. If you are interested in attending similar sessions, you can check Cytel’s list of upcoming events here.

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Biotechs and Medtechs, don’t forget your market access strategy (part 4 of 4): How to optimize your market access planning approach

December 5, 2019

Author: Michael S. Paas, Market Access & Commercialization Expert, Executive at AbbVie and Guest Author at Cytel

In crafting your market access strategy, it can be valuable to follow these five best practices:

  1. Start planning as early as possible in the drug or device development process, to give yourself enough time to make informed, optimal decisions, and adjust your strategy when needed;
  2. Plan for global markets and seek early advice from payers and HTA agencies, where possible. There are many different agencies and payers to think about when you launch globally, so it’s vital to ensure you are sufficiently addressing the requirements of the priority markets. Even if you do not plan to commercialize by yourself in countries outside the US, careful, early market access planning with key global markets in mind can maximize the attractiveness of your asset to potential licensors or partners;
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Biotechs and Medtechs, don’t forget your market access strategy (part 2 of 4): The critical role of market access planning in clinical development

November 21, 2019

Author: Michael S. Paas, Market Access & Commercialization Expert, Executive at AbbVie and Guest Author at Cytel

In my previous post, I established the importance of market access strategy in the clinical development process and why emerging biotechs cannot afford to overlook it.

Click on the button if you missed Part 1 or want to revisit it.

Read Part 1

It is imperative to start developing your strategy with market access due diligence and value story creation early in the product development (at least by phase II of drug development or the proof-of-concept phase of a device development). Impactful market access planning involves designing your clinical programs so they sufficiently address the evidence needs of market access stakeholders, patients, and regulators. This means demonstrating the value of your therapy to payers and HTA agencies by generating compelling and robust clinical trial data against appropriate comparators, augmented where possible and helpful with real-world evidence, health economic arguments, economic models and/or relevant patient-reported outcomes.

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