exemplifi plified ed for r a proje ject ct to determi ermine - - PowerPoint PPT Presentation

Scientifi ntific c collaborati

• ration
• n wi

with African ican stud udents ents in mathemati hematics, cs, exemplifi plified ed for r a proje ject ct to determi ermine ne the assuran rance ce durin ing project ct planning of clinical al developm pment ent program rams

• A. R

Ring1,2

,2,

, D. Habima imana na3, G. T Tumusab musabe3, , W. Nakiy kiying ingi3

1 University of the Free State, South Africa 2 medac GmbH, Germany 3 AIMS Rwanda, Germany

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Overview

• https://nexteinstein.org/

und https://nef.org/

• https://www.aims.ac.rw
• A day at AIMS Rwanda https://youtu.be/wtqVTiK5L1w
• RSS-Initiative

https://docs.google.com/forms/d/e/1FAIpQLSc4DwjDjY06BJohRNc9SnpeFhd9O9zBV95F3pKILbZ4o3t2pQ/viewform

• http://www.lancaster.ac.uk/staff/giorgi/AIMS_syllabus.pdf
• https://de.wikipedia.org/wiki/African_Institute_for_Mathematical_Sciences
• https://www.nexteinstein.org/research/researchchairprogram

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AIMS in Websites

• Understanding of the parameters that determine the power
• Exploring the assurance concept for a quantitative

endpoint

• Based on Chuang-Stein 2006
• Extending the concept to optimize the sample size of two

subsequent trials

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Objective

• Exploring statistical power

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Implementation of Chuang-Stein paper

• The illustration of the method
• Uncertainty of delta
• Estimated from

Phase II trial

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Implementation of Chuang-Stein paper

𝛿 𝑜, 𝑥𝜄0, 𝜏0 = න 𝜌 𝑜, 𝜄, 𝜏0 𝑥𝜄0 𝜄 𝑒𝜄

• The illustration of the method (uncertainty of delta)

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Implementation of Chuang-Stein paper

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Extension to planning optimal sample sizes

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Extension to planning optimal sample sizes

𝑜𝑝𝑚𝑒 𝛿0, 𝑥𝜄0, 𝜏0 = 𝑜𝑝𝑚𝑒 | (𝑜𝑝𝑚𝑒 + 𝑜𝑜𝑓𝑥) is minimal ∧ 𝛿 𝑜𝑜𝑓𝑥, 𝑥𝜄0, 𝑜𝑝𝑚𝑒, 𝜏0 = 𝛿0

Optimum sample size of the old trial for desired assurance, so that total sample size of both trials is minimal, assuming the true 𝜄0 is known (before old trial is performed)

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Extension to planning optimal sample sizes

• Comparison of assurance with approaches in Whitehead

paper

• Extension to uncertainty of expected treatment effect in

pilot trial

• Derivation of optimal sample size of pilot trial

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Future plans

ሷ 𝛿 𝑜𝑜𝑓𝑥, 𝑥𝜄0,𝜏𝑣, 𝑜𝑝𝑚𝑒, 𝜏0 = න න 𝜌 𝑜𝑜𝑓𝑥, 𝜄, 𝜏0 𝑥𝜐 𝜄 𝑒𝜄 𝑥𝜄0,𝜏𝑣 𝜐 𝑒𝜐

𝑥𝜄0,𝜏𝑣 = 𝑂 𝜄0, 𝜏𝑣 𝑥𝜐 = 𝑂(𝜐, 𝜏0/ 𝑜𝑝𝑚𝑒) 𝑜𝑝𝑚𝑒 𝛿0, 𝑥𝜄0, 𝜏0 = 𝑜𝑝𝑚𝑒 | (𝑜𝑝𝑚𝑒 + 𝑜𝑜𝑓𝑥) is minimal ∧ ሷ 𝛿 𝑜, 𝑥𝜄0,𝜏𝑣, 𝑜𝑝𝑚𝑒, 𝜏0 = 𝛿0

Thank you for your attention!