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Content provided by Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry, Alexander Schacht, Benjamin Piske, and Leaders in the pharma industry. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry, Alexander Schacht, Benjamin Piske, and Leaders in the pharma industry or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://staging.podcastplayer.com/legal.
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Clarifying confusions around interim, primary, final, and other analyses in clinical trial

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Manage episode 477094342 series 2400265
Content provided by Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry, Alexander Schacht, Benjamin Piske, and Leaders in the pharma industry. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry, Alexander Schacht, Benjamin Piske, and Leaders in the pharma industry or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://staging.podcastplayer.com/legal.
Interview with Kaspar Rufibach

What You’ll Learn in This Episode:

✔ The true definitions of interim, final, primary, confirmatory, and updated analyses

✔ Why a “final analysis” doesn’t always mean “last analysis”

✔ How language choice can impact stakeholder trust and regulatory interpretation

✔ The operational vs. statistical meaning of “stopping a study”

✔ When to use which data cuts and how to define your analysis set

✔ The nuances of estimation vs. hypothesis testing after stopping a trial

✔ Why clarity in communication is just as critical as technical accuracy

Why You Should Listen:

Even experienced statisticians often use terms like “final” or “interim” inconsistently, which can cause confusion not just within study teams, but also with regulators, clinicians, and the public.

Kaspar provides much-needed clarity on how we as statisticians can:

  • Use more precise terminology when describing study analyses,
  • Align our language with stakeholders,
  • Avoid miscommunication that can erode public and regulatory trust, and
  • Educate others on the importance of estimating vs. testing.

Resources & Links:

🔗 LinkedIn article by Kaspar Rufibach on clinical trial

🔗 Preprint Paper (with industry and regulatory co-authors)

🔗 The Effective Statistician Academy – I offer free and premium resources to help you become a more effective statistician.

🔗 Medical Data Leaders Community – Join my network of statisticians and data leaders to enhance your influencing skills.

🔗 My New Book: How to Be an Effective Statistician - Volume 1 – It’s packed with insights to help statisticians, data scientists, and quantitative professionals excel as leaders, collaborators, and change-makers in healthcare and medicine.

🔗 PSI (Statistical Community in Healthcare) – Access webinars, training, and networking opportunities.

Join the Conversation:
Did you find this episode helpful? Share it with your colleagues and let me know your thoughts! Connect with me on LinkedIn and be part of the discussion.

Subscribe & Stay Updated:
Never miss an episode! Subscribe to The Effective Statistician on your favorite podcast platform and continue growing your influence as a statistician.

  continue reading

443 episodes

Artwork
iconShare
 
Manage episode 477094342 series 2400265
Content provided by Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry, Alexander Schacht, Benjamin Piske, and Leaders in the pharma industry. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry, Alexander Schacht, Benjamin Piske, and Leaders in the pharma industry or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://staging.podcastplayer.com/legal.
Interview with Kaspar Rufibach

What You’ll Learn in This Episode:

✔ The true definitions of interim, final, primary, confirmatory, and updated analyses

✔ Why a “final analysis” doesn’t always mean “last analysis”

✔ How language choice can impact stakeholder trust and regulatory interpretation

✔ The operational vs. statistical meaning of “stopping a study”

✔ When to use which data cuts and how to define your analysis set

✔ The nuances of estimation vs. hypothesis testing after stopping a trial

✔ Why clarity in communication is just as critical as technical accuracy

Why You Should Listen:

Even experienced statisticians often use terms like “final” or “interim” inconsistently, which can cause confusion not just within study teams, but also with regulators, clinicians, and the public.

Kaspar provides much-needed clarity on how we as statisticians can:

  • Use more precise terminology when describing study analyses,
  • Align our language with stakeholders,
  • Avoid miscommunication that can erode public and regulatory trust, and
  • Educate others on the importance of estimating vs. testing.

Resources & Links:

🔗 LinkedIn article by Kaspar Rufibach on clinical trial

🔗 Preprint Paper (with industry and regulatory co-authors)

🔗 The Effective Statistician Academy – I offer free and premium resources to help you become a more effective statistician.

🔗 Medical Data Leaders Community – Join my network of statisticians and data leaders to enhance your influencing skills.

🔗 My New Book: How to Be an Effective Statistician - Volume 1 – It’s packed with insights to help statisticians, data scientists, and quantitative professionals excel as leaders, collaborators, and change-makers in healthcare and medicine.

🔗 PSI (Statistical Community in Healthcare) – Access webinars, training, and networking opportunities.

Join the Conversation:
Did you find this episode helpful? Share it with your colleagues and let me know your thoughts! Connect with me on LinkedIn and be part of the discussion.

Subscribe & Stay Updated:
Never miss an episode! Subscribe to The Effective Statistician on your favorite podcast platform and continue growing your influence as a statistician.

  continue reading

443 episodes

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