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Clinical Trials Unraveled: Workshop Reading Hub

Welcome to the Reading Materials Portal for the Statistics in Clinical Trials Unravelled workshop series — your go-to space to explore analytics, design strategies, and statistical innovations that power modern clinical research.

Each session below features essential readings, practical tool guides, and on-demand webinar recordings to deepen your understanding and strengthen your trial design game.

Dive in, explore, and transform data into discovery!

Workshop Reading Materials

1. Racing Against Time: Survival Analysis Hacks

Focus: Kaplan-Meier curves, Cox models, adaptive survival designs.

Highlight: Outsmart time with survival stats and real-time trial monitoring tools like EAST.

  • 📘 Reading 1: Survival Analysis in Clinical Trials (PDF)
  • 📗 Reading 2: Adaptive Designs and Time-to-Event Models (Article)
  • 📙 Reading 3: Using EAST for Survival Trial Monitoring (Guide)

🎥 Webinar Video: Racing Against Time Session Replay

2. Filling the Blanks: Cracking Missing Data

Focus: MCAR, MAR, MNAR; imputation techniques in R.

Highlight: Turn missing values into meaningful insights using MICE and sensitivity checks.

  • 📘 Reading 1: Handling Missing Data in Clinical Research
  • 📗 Reading 2: Multiple Imputation Using R Packages (MICE, smcfcs, mitml)
  • 📙 Reading 3: EMA/FDA Guidance on Missing Data

🎥 Webinar Video: Cracking Missing Data Session Replay

3. Cash Meets Care: Health Economics

Focus: ICER, QALY, and cost-effectiveness modeling.

Highlight: Learn to quantify treatment value — where saving lives meets saving budgets.

  • 📘 Reading 1: Introduction to Health Economic Evaluations
  • 📗 Reading 2: QALY and ICER Explained
  • 📙 Reading 3: Decision Trees and Markov Models in Trials

🎥 Webinar Video: Cash Meets Care Session Replay

4. Untangling the Mess: Mixed Models

Focus: Mixed models for repeated measures (MMRM), cluster trials, R packages.

Highlight: Decode complexity with lme4 and brms to uncover hidden treatment effects.

  • 📘 Reading 1: Mastering Mixed Models in R
  • 📗 Reading 2: Clustered Trial Design and Analysis
  • 📙 Reading 3: MMRM vs. LOCF — Choosing the Right Model

🎥 Webinar Video: Mixed Models Session Replay

5. Eyes on the Prize: Monitoring Tricks

Focus: DSMB oversight, alpha-spending functions, interim monitoring.

Highlight: Learn how monitoring protects science and patients alike.

  • 📘 Reading 1: Principles of Data Monitoring Committees
  • 📗 Reading 2: Alpha-Spending Boundaries in Interim Analysis
  • 📙 Reading 3: Practical DMC Charter Templates

🎥 Webinar Video: Monitoring Tricks Session Replay

6. Bend, Don’t Break: Adaptive Trials

Focus: Adaptive trial design, sample size re-estimation, regulatory alignment.

Highlight: Keep trials flexible while maintaining statistical rigor.

  • 📘 Reading 1: Adaptive Trial Design Fundamentals
  • 📗 Reading 2: Using EAST and rpact for Adaptive Design Simulation
  • 📙 Reading 3: Regulatory Perspectives on Adaptive Methods

🎥 Webinar Video: Adaptive Trials Session Replay

7. Knowing When to Quit: Sequential Designs

Focus: Group sequential trials, early stopping rules, alpha control.

Highlight: Master early exits without compromising trial validity.

  • 📘 Reading 1: Sequential Trial Design Theory
  • 📗 Reading 2: O’Brien-Fleming and Pocock Boundaries Explained
  • 📙 Reading 3: Implementing gsDesign in R

🎥 Webinar Video: Sequential Designs Session Replay

8. Squad Goals: Multi-Arm Trials

Focus: MAMS and platform trials using shared control arms.

Highlight: Test multiple treatments efficiently with flexible, scalable frameworks.

  • 📘 Reading 1: Design and Analysis of Multi-Arm Multi-Stage Trials
  • 📗 Reading 2: Platform Trial Innovations
  • 📙 Reading 3: R Implementation for MAMS Designs

🎥 Webinar Video: Multi-Arm Trials Session Replay

9. Roll the Dice: Bayesian Designs

Focus: Bayesian trial methods, priors, posterior inference, predictive probability.

Highlight: Embrace uncertainty — use Bayesian tools for smarter, faster decisions.

  • 📘 Reading 1: Bayesian Thinking in Clinical Research
  • 📗 Reading 2: Priors, Posteriors, and Predictive Probability
  • 📙 Reading 3: WinBUGS & R for Bayesian Analysis

🎥 Webinar Video: Bayesian Designs Session Replay

10. Kicking It Off: Early Phase Trials

Focus: Modern dose-finding methods — CRM, BOIN, mTPI.

Highlight: Upgrade early-phase designs for smarter, safer dose decisions.

  • 📘 Reading 1: Model-Based Dose Escalation Designs
  • 📗 Reading 2: Comparing 3+3, CRM, and BOIN Approaches
  • 📙 Reading 3: Simulation Tools for Phase I/II Designs

🎥 Webinar Video: Early Phase Trials Session Replay

Miscellaneous Reading Material

Biostatistics and Design of Clinical Trials : Concepts from Basics to Advanced

Introduction

Welcome to the StatsCure Learning Repository — a dedicated section providing detailed reading material on Biostatistics and Clinical Trial Design.

This curated compilation serves as a one-stop academic and practical guide for clinicians, researchers, statisticians, and postgraduate scholars. The material spans from fundamental statistical concepts to advanced adaptive, Bayesian, and simulation-based trial methodologies, aligning both with academic curricula and applied clinical research needs.

Each topic is carefully categorized from basic to advanced, allowing readers to explore concepts progressively. Each listed item will link to a downloadable theory PDF or learning module, supported by real-life examples, equations, and visual illustrations. The section is structured into two major parts:

  1. Biostatistics & Statistical Methods
  2. Designs and Methodologies in Clinical Trials

Link to the detailed reading materials - https://drive.google.com/drive/folders/1gtenwlbjZ0K4KF1oblwDb0GM0ca7vjGe?usp=sharing