Clinical Trial Design in Oncology Course

Lesson 1 • Ethical Principles in Oncology Research

Examines informed consent, equipoise, and vulnerability in cancer populations. Grounds all subsequent design decisions in ethical obligations to participants.

Lesson 2 • Cancer Biology Essentials for Trialists

Covers tumor biology, hallmarks of cancer, and oncogenic pathways relevant to trial design. Establishes the scientific rationale that drives endpoint and population choices.

Lesson 3 • Overview of the Clinical Trial Framework

Introduces the phased trial structure and the roles of sponsors, investigators, and regulators. Provides the structural map students will navigate throughout the course.

Lesson 1 • Surrogate and Intermediate Endpoints

Evaluates surrogate endpoints such as response rate and their validation requirements. Teaches students to assess when surrogates are scientifically and regulatorily justified.

Lesson 2 • Safety Endpoints and Toxicity Grading

Defines adverse event classification, grading scales, and dose-limiting toxicity criteria. Links safety endpoint design to dose-finding and stopping rules.

Lesson 3 • Patient-Reported Outcomes in Oncology

Introduces PRO instruments, their integration into trial protocols, and regulatory guidance on their use. Emphasizes capturing the patient experience alongside clinical measures.

Lesson 4 • Tumor Response Assessment Methods

Covers standardized imaging-based response criteria and their application across tumor types. Ensures students can specify assessment schedules and adjudication procedures.

Lesson 1 • Objectives and Population of Phase I Trials

Defines the safety, pharmacokinetic, and dose-finding goals of Phase I oncology studies. Establishes why patient selection and starting dose rationale are critical design elements.

Lesson 2 • Combination Therapy Phase I Designs

Addresses the added complexity of dose-finding for two or more agents given simultaneously. Teaches matrix-based and partial ordering designs for combination escalation.

Lesson 3 • Model-Based Dose-Escalation Methods

Introduces the Continual Reassessment Method and Bayesian Optimal Interval designs. Students learn to apply model-based approaches that improve accuracy and efficiency.

Lesson 4 • Rule-Based Dose-Escalation Designs

Explains the 3+3 design and its variants, including their operational simplicity and statistical limitations. Provides a baseline for comparing more advanced methods.

Lesson 1 • Blinding Levels and Unblinding Procedures

Defines single, double, and triple blinding and their feasibility in oncology contexts. Addresses planned and emergency unblinding to protect trial integrity.

Lesson 2 • Stratification and Minimization Methods

Covers stratified block randomization and covariate-adaptive minimization to balance prognostic factors. Teaches students to select stratification variables without over-stratifying.

Lesson 3 • Principles of Randomization in Oncology

Explains why randomization is the cornerstone of causal inference and how it controls confounding. Connects randomization to the validity of treatment comparisons in oncology.

Lesson 1 • Biomarker-Stratified Phase II Designs

Covers enrichment, all-comers, and biomarker-stratified designs for targeted agents. Students learn to match design choice to the strength of the biomarker hypothesis.

Lesson 2 • Randomized Phase II Designs

Introduces randomized selection and screening designs that improve signal detection over single-arm approaches. Clarifies the distinction between Phase II and Phase III inferential goals.

Lesson 3 • Seamless Phase II/III Designs

Explains operationally and inferentially seamless adaptive designs that combine Phase II and III. Teaches how data from the learning stage can be combined with the confirmatory stage.

Lesson 1 • Interim Analysis and Adaptive Elements

Introduces group sequential methods, alpha spending functions, and adaptive sample size re-estimation. Teaches students to pre-specify interim decision rules that preserve type I error.

Lesson 2 • Survival Analysis Methods for Phase III

Covers log-rank tests, Cox proportional hazards models, and restricted mean survival time analysis. Connects statistical method choice to the estimand and proportional hazards assumption.

Lesson 3 • Sample Size and Power Calculations

Covers event-driven and fixed sample size calculations for time-to-event and binary endpoints. Students justify assumptions and conduct sensitivity analyses on key parameters.

Lesson 4 • Multiplicity Control in Phase III

Addresses multiple endpoints, subgroups, and treatment arms as sources of multiplicity inflation. Students apply hierarchical testing and gatekeeping procedures to control family-wise error.

Lesson 1 • Liquid Biopsy and Genomic Endpoints

Examines circulating tumor DNA, cell-free DNA, and tumor mutational burden as trial endpoints. Addresses analytical validity and regulatory acceptance of genomic biomarker endpoints.

Lesson 2 • Predictive Versus Prognostic Biomarkers

Distinguishes predictive from prognostic biomarkers and their distinct roles in trial design. Establishes the analytical framework for biomarker-by-treatment interaction testing.

Lesson 3 • Master Protocol Designs

Introduces umbrella, basket, and platform trial architectures and their operational infrastructure. Students learn to design shared control arms and biomarker-driven sub-study allocation.

Lesson 4 • Enrichment and Stratified Designs

Covers prospective enrichment, biomarker-stratified, and hybrid designs for targeted therapies. Students evaluate trade-offs between statistical power and generalizability.

Lesson 1 • Protocol Architecture and Core Sections

Maps the standard structure of an oncology trial protocol and the purpose of each section. Students draft coherent, internally consistent protocol documents aligned with regulatory templates.

Lesson 2 • Regulatory Submission Strategy

Examines the content and strategy for regulatory submissions seeking trial authorization. Students learn to anticipate agency questions and prepare robust scientific justifications.

Lesson 3 • Data Safety Monitoring Board Operations

Defines DSMB charter elements, meeting procedures, and decision-making authority. Students design monitoring plans that protect participants while preserving trial integrity.

Lesson 4 • Protocol Amendments and Version Control

Covers the classification, justification, and regulatory filing of protocol amendments. Teaches students to manage amendment impact on ongoing enrollment and data integrity.