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https://www.cytel.com/blog/the-fda-real-time-oncology-review-process-an-opportunity-challenge-for-sponsors
November 30, 2021
The FDA “Real-Time Oncology Review (RTOR)”[1] is an “FDA project started in 2018 to facilitate earlier submission of..
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https://www.cytel.com/blog/dr.-julia-edwards-on-findings-from-published-trial-data-on-promising-zone-designs
November 30, 2021
The aim of any clinical research is to detect the actual difference in treatment effect between two groups (power) and..
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https://www.cytel.com/blog/using-single-arm-trials-for-hta-submissions-an-issue-panel-presentation-by-dr.-bart-heeg-and-maria-rizzo
November 23, 2021
A randomized clinical trial (RCT) is the gold standard approach to demonstrate the efficacy and safety of novel..
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https://www.cytel.com/blog/how-to-harness-technology-to-align-regulatory-and-market-access-evidence-strategies-a-new-podcast
November 17, 2021
Traditionally, the teams responsible for clinical development and regulatory submissions do not consult the market..
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https://www.cytel.com/blog/optimal-promising-zone-designs-what-biotechs-need-to-know
November 15, 2021
Since its first publication ten years ago, Cyrus Mehta and Stuart Pocock’s Promising Zone Design for sample size..
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https://www.cytel.com/blog/championing-rwe-heor-at-virtual-ispor-europe-2021
November 11, 2021
The value of Real World Evidence (RWE) is well known to many stakeholders, but its full potential for market access and..
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https://www.cytel.com/blog/evolving-the-study-design-process-webcast-by-yannis-jemiai
November 10, 2021
There are many reasons why traditional approaches to designing a clinical study are generally suboptimal and do not..
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https://www.cytel.com/blog/keeping-the-promise-ten-year-anniversary-of-the-promising-zone-design
November 8, 2021
Ten years ago Cytel co-founder Professor Cyrus Mehta and Professor Stuart Pocock of the London School of Hygiene and..
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https://www.cytel.com/blog/join-cytel-for-heor-insights-at-ispor-eu-2021
November 4, 2021
The prominent European conference for Health Economics and Outcomes Research (HEOR), ISPOR Europe 2021, is around the..
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