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Resources

Resources

A curated collection of resources for biostatisticians and clinical scientists working in biomarker-driven drug development.

Books & Textbooks

  • Bayesian Adaptive Methods for Clinical Trials — Berry, Carlin, Lee & Muller
  • Clinical Trials: A Methodologic Perspective — Piantadosi
  • Sample Size Tables for Clinical Studies — Machin, Campbell, Tan & Tan

Software & Packages

  • BOIN R package — Bayesian optimal interval design for dose finding
  • trialr — Bayesian clinical trial designs in R/Stan
  • rpact — Confirmatory adaptive clinical trial design and analysis

Regulatory Guidance

  • FDA Project Optimus — Dose optimisation in oncology
  • FDA Guidance on Adaptive Designs — Adaptive Designs for Clinical Trials of Drugs and Biologics
  • ICH E9(R1) — Estimands and Sensitivity Analysis in Clinical Trials

Publications & Posts

  • Biomarker-Driven Clinical Trials in Oncology — Precision for Medicine Blog
  • Basket Trials in Precision Oncology: Under the Hood — LinkedIn Article
 

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