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

COVID-19 Trial Tracker Updates (December 8)

December 8, 2020

The Cytel COVID-19 Trial Tracker brings you an up to the minute, real time dashboard about COVID-19 trials around the world. This snapshot gives you a quick briefing on the current state of COVID-19 therapy and vaccines development.

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Mapping the Landscape of COVID-19 Clinical Trials in the US

December 1, 2020

An extraordinary amount of global research is underway as the COVID-19 pandemic continues to evolve and spread. As several entities develop curative and preventive responses against COVID-19, alignment with regulatory recommendations is key for developing effective and safe intervention. Moreover, fast regulatory approval will translate into early availability of interventions to address unmet needs.

Continue reading to get an overview of the registered COVID-19 clinical trials landscape, with a story on the special attention received by Hydroxychloroquine treatment.

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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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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 3 of 4): Harnessing the value of market access planning

December 2, 2019

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

Addressing the myriad of considerations required for market access planning can be complex and time-consuming, so it is vital to give yourself enough time to make informed decisions. As such, starting to plan your market access strategy at least by early phase II or the proof-of-concept phase of device development can help you inform the design of the clinical program in such a way to ideally generate evidence credible and compelling to payer and HTA stakeholders, as well as regulators, in order to maximize the commercial success of your drug or device.

Planning early also gives you the opportunity to make adjustments along the trajectory of development as you gain new information and insights about the asset itself, as well as about the payer and competitive environment.

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