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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://podcastplayer.com/legal.
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How to communicate results from adaptive studies simple, but still correct

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Manage episode 516176260 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://podcastplayer.com/legal.
A Conversation with Kaspar Rufibach

Why You Should Listen:

✔ You need clear, defensible language for papers, conferences, and labels when your study had interims and stopping rules.

✔ You’ll learn practical rules-of-thumb for when “naïve” estimates are okay—and when to adjust.

✔ You’ll hear what regulators typically focus on vs. what patients and clinicians actually want to know.

Episode Highlights:

02:00 – Why communicating adaptive results is hard (and how simple can still be correct)

04:14 – What bias are we actually interested in? Conditional vs. unconditional

07:20 – Consequences for point estimates and confidence intervals

09:15 – Ordering the sample space across stages; stage-wise ordering and p-values

12:23 – Median-unbiased estimation: what it is and when to use it

13:38 – Secondary endpoints, safety, and multiplicity strategies

16:13 – Estimation efficiency vs. unbiasedness: what should we optimize?

17:40 – Communicating to scientific vs. lay audiences

18:36 – Should we publish p-values for secondary endpoints in adaptive trials?

20:20 – No one-size-fits-all template—and why fairness matters across programs

20:30 – Pre-planning or bust: why post-hoc “fixes” don’t carry the properties we need

21:49 – Trust, reproducibility, and credible decision-making

23:16 – ICHE20: read it, comment, improve it

Links:

🔗 ICHE20 (Adaptive Clinical Trials) – draft guidance: worth reading for its perspective on estimation and communication.

🔗 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

463 episodes

Artwork
iconShare
 
Manage episode 516176260 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://podcastplayer.com/legal.
A Conversation with Kaspar Rufibach

Why You Should Listen:

✔ You need clear, defensible language for papers, conferences, and labels when your study had interims and stopping rules.

✔ You’ll learn practical rules-of-thumb for when “naïve” estimates are okay—and when to adjust.

✔ You’ll hear what regulators typically focus on vs. what patients and clinicians actually want to know.

Episode Highlights:

02:00 – Why communicating adaptive results is hard (and how simple can still be correct)

04:14 – What bias are we actually interested in? Conditional vs. unconditional

07:20 – Consequences for point estimates and confidence intervals

09:15 – Ordering the sample space across stages; stage-wise ordering and p-values

12:23 – Median-unbiased estimation: what it is and when to use it

13:38 – Secondary endpoints, safety, and multiplicity strategies

16:13 – Estimation efficiency vs. unbiasedness: what should we optimize?

17:40 – Communicating to scientific vs. lay audiences

18:36 – Should we publish p-values for secondary endpoints in adaptive trials?

20:20 – No one-size-fits-all template—and why fairness matters across programs

20:30 – Pre-planning or bust: why post-hoc “fixes” don’t carry the properties we need

21:49 – Trust, reproducibility, and credible decision-making

23:16 – ICHE20: read it, comment, improve it

Links:

🔗 ICHE20 (Adaptive Clinical Trials) – draft guidance: worth reading for its perspective on estimation and communication.

🔗 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

463 episodes

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