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Generalizing boundaries for triangular designs, and efficacy estimation at extended follow-ups.

Annabel Allison1,2, Tansy Edwards3, Raymond Omollo4,5

  • 1Lancaster University, Lancaster, LA1 4YW, UK. a.allison@sheffield.ac.uk.

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This study introduces a generalized triangular design for clinical trials, ensuring minimum sample sizes for pharmacokinetic analysis. The shrinkage estimator (SHE) is recommended for estimating treatment efficacy at extended follow-up, outperforming other methods.

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Area of Science:

  • Clinical trial design
  • Parasitic disease research
  • Pharmacokinetics

Background:

  • Visceral leishmaniasis (VL) is a fatal sandfly-transmitted parasitic disease.
  • Phase II VL trials assess safety, efficacy, and pharmacokinetics for combination treatments.
  • Efficacy is measured at initial and definitive (6-month) cure, accounting for delayed responses and relapses.

Purpose of the Study:

  • To generalize the triangular design for clinical trials, incorporating a minimum sample size for pharmacokinetic analyses.
  • To evaluate methods for estimating treatment efficacy at extended follow-up within sequential trial designs.

Main Methods:

  • Developed generalized triangular design R functions with minimum sample size constraints.
  • Assessed shrinkage estimator (SHE), probability tree estimator (PTE), and maximum likelihood estimator (MLE) via simulation for extended follow-up efficacy estimation.

Main Results:

  • The SHE and PTE are suitable for extended follow-up efficacy estimation.
  • SHE demonstrated superior performance with lower bias and root mean square error, and higher coverage probabilities compared to PTE.
  • Maximum likelihood estimation (MLE) can lead to biased, overestimated efficacy results.

Conclusions:

  • Generalized triangular designs are adaptable for pharmacokinetic analysis requirements.
  • SHE is recommended for trials with multiple treatments due to its accuracy.
  • PTE serves as a viable alternative for single-arm trials or when SHE implementation is complex.