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

Career Perspectives: Interview with Marc Lefebvre-Gouy, Statistical Programmer

April 7, 2020

Cytel has industry-leading experts in Statistical Programming with years of SAS® Programming expertise and in-depth knowledge of the specific clinical subject matter. Their insights into strategy, and high competence in project management ensure a new twist on the traditional CRO.

In February 2020 we interviewed Marc Lefebvre-Gouy who is a lead statistical programmer at Cytel in France. Marc made a career transition from genetics to statistical programming and in this interview, he speaks to us about programmers working across therapeutic areas, programming challenges across phases of a trial, and the top technical competencies every programmer must have. He also gives us a sneak peek of his hobby of cooking and his love for wine.

Read More

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.

download ebook

 

 

 

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.

Read More

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.

Read More

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.

Read More

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.

download ebook

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.

Read More

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.

Register

Read More

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.

download ebook

Read More

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.

Read More

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;
Read More