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Single arm studies

HTA, Innovation / By / 2023-02-28

Why are companies often running single arm studies in development?  What are the potential drawbacks and why is it not a binary choice between full comparative study and single arm trial? What are solutions in between to find a balance between feasibility and rigour? Single arm studies are a popular method for collecting data despite being critiqued for decades. It is a type of research design in which the investigator only observes one group of participants over time.  This design is often used when sponsors claim it would be unethical to randomise patients into different groups or when comparing two treatments would …

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Future implications of EU HTA and how Next Gen get involved

HTA, Innovation / By / 2023-02-07

All statisticians in the Pharmaceutical Industry will be impacted by the new EU HTA regulation. Activities around HTA submissions will happen earlier than currently, in parallel to the regulatory approval process for marketing authorization. There will be an increased scope of evidence for the joint clinical assessment to fulfill the needs of all EU member states, and so there will be a large package of statistical analyses that need to be provided in addition to the submission to the regulatory bodies. This will redefine how you, as a statistician, work, and with whom you need to collaborate. Both HTA and clinical …

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What is EU HTA and why should statisticians care?

HTA / By / 2023-01-16

As a statistician, have you ever wondered—why are statistical analyses for HTA dossiers differ from those in regulatory dossiers? Aren’t they both just benefit-risk assessments? In this podcast, we review some of the history and background of how HTA and regulatory decision making have common sources of information, but different utility functions for how they use that information. Why have we had a common European regulatory framework, but not a common HTA framework—until the near future.   And what is the EU HTA Regulation? Why has it been established, what does it hope to accomplish…..and why does this matter to statisticians …

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