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ForwardBasics of Clinical Trial Designs
2023 SNO Introduction to Clinical Trial Design and Protocol Development Workshop
The Society for Neuro-Oncology is pleased to announce the 5th Annual Introduction to Clinical Trial Design and Protocol Development Workshop. This year’s workshop will be held in person on Wednesday, November 15, in Vancouver, Canada, just prior to the SNO Annual Meeting and Education Day.
An overview of the recorded lectures can be found attached below.
The Program of the 2023 SNO Introduction to Clinical Trial Design and Protocol Development Workshop can be found attached below.
Planning Committee:
- Stephen Bagley, University of Pennsylvania
- Susan Chang, University of California, San Francisco
- Maryam Fouladi, Cincinnati Children's Hospital
- Susan Geyer, Mayo Clinic
- Mustafa Khasraw, Duke University
- Ian Parney, Mayo Clinic
- Patrick Wen, Dana-Farber Cancer Institute
- Jennifer Yu, Cleveland Clinic
Learning Objectives
Educational Goals:
- Upon completion of this course, participants will have an improved understanding of the practical aspects of CNS trials, including:
- Understanding the fundamentals of good trial design and protocol development,
- Understanding the scientific, statistical, regulatory, logistical and ethical aspects of CNS trials,
- Integrating correlative studies in CNS trials,
- Mitigating challenges to accrual and overcoming accrual barriers, and
- Anticipating the future direction of CNS trials.
Additional Information
| Attachment | Size |
|---|---|
 Program 2023 SNO Clinical Trials Scholars Workshop.pdf | 162.73 KB |
| SNO Workshop Overview of Lectures.pdf | 321.7 KB |
Scholars Homework
The following recorded content is required viewing prior to joining the in-person Workshop. It provides a foundational overview of clinical trial design and protocol development that will allow breakout groups at the Workshop to engage in deeper learning and highly productive and relevant discussions.
Below is an outline of the three sections each scholar is being asked to complete along with additional recommended talks if relevant.
Mandatory talks are in bold
Optional Recommended talks are italic
1. Research Question Considerations:
- Fundamentals of Clinical Trial Design (Steven Piantadosi)
- The Research Question (Steven Piantadosi)
- Statistical Issues (trial design) (Annette Molinaro)
- Types of Trial Designs (Steven Piantadosi)
2. What Kind of Trial and How Big:
- Therapeutic Development (Steven Piantadosi)
- How to Decide When to Bring a Therapy to Trial (assessment of preclinical data) (Tim Cloughesy)
- Phase 0” and Other Surgical Trials (Ian Parney)
- Phase I Trials (Jennifer Clarke)
- Phase II Trials (Evanthia Galanis)
- Phase III Trials (Martin van den Bent)
- Novel Designs (umbrella, basket, platform, adaptive randomization, external control) (Rif Rahman)
3. How to Write a Protocol:
- Background and Rationale (Mustafa Khasraw)
Eligibility
- Clinical Trial Accrual (David Reardon)
- Eligibility Criteria (Eudocia Quant Lee)
- Issues Related to Disparities (Shawn Hervey Jumper)
- Improving Representation in Brain Tumor Clinical Trials (Joshua Budhu, Ugonma Chukwueke)
- Cohort Issues, Part A (Steven Piantadosi)
- Cohort Issues, Part B (Steven Piantadosi)
- Cohort Issues, Part C (Steven Piantadosi)
Response Assessment
- Response Assessments and Endpoints (Patrick Wen)
- Clinical Outcomes Assessment (Terri Armstrong)
- Outcome Measures, Part A (Steven Piantadosi)
- Outcome Measures, Part B (Steven Piantadosi)
- Outcome Measures, Part C (Steven Piantadosi)
Correlative Studies
- Correlative and Biomarker Studies (Erik Sulman)
Statistical Issues
- Working with a Statistician (Susan Geyer)
- Bias and Random Error, Part A (Steven Piantadosi)
- Bias and Random Error, Part B (Steven Piantadosi)
- Bias and Random Error, Part C (Steven Piantadosi)
- Precision and Sample Size, Part A (Steven Piantadosi)
- Precision and Sample Size, Part B (Steven Piantadosi)
- Precision and Sample Size, Part C (Steven Piantadosi)
- Basics of Analysis, Part A (Steven Piantadosi)
- Basics of Analysis, Part B (Steven Piantadosi)
- Basics of Analysis, Part C (Steven Piantadosi)
- Interpreting Trial Data (Steven Piantadosi)
Regulatory Issues
- PI Responsibilities and Regulatory Issues (Susan Chang)
- FDA Perspective in Neuro-oncology Trials (Gautam Mehta)
Ancillary Issues
- Pediatric Trial Considerations (Maryam Fouladi)
- Bridging Academia and Industry (including funding) (Mustafa Khasraw)
- Nuts and Bolts of Developing an Investigator-Initiated Trials (Vinay Puduvalli)
- Patient Advocacy in Clinical Trials (Nicole Wilmarth)
- Reflections of Experienced Clinical Trialists (Mark Gilbert, Stuart Grossman, Minesh Mehta)
Presenting Speakers:
- Terri Armstrong, National Cancer Institute
- Joshua Budhu, Memorial Sloan Kettering Cancer Center
- Susan Chang, University of California, San Francisco
- Ugonma Chukwueke, Dana-Farber Cancer Institute
- Jennifer Clarke, University of California, San Francisco
- Tim Cloughesy, University of California, Los Angeles
- Maryam Fouladi, Nationwide Children’s Hospital
- Evanthia Galanis, Mayo Clinic
- Susan Geyer, Mayo Clinic
- Mark Gilbert, National Institutes of Health
- Stuart Grossman, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
- Shawn Hervey Jumper, University of California, San Francisco
- Mustafa Khasraw, Duke University
- Gautam Mehta, US Food & Drug Administration
- Minesh Mehta, Miami Cancer Institute
- Annette Molinaro, University of California, San Francisco
- Ian Parney, Mayo Clinic
- Eudocia Quant Lee, Dana-Farber Cancer Institute
- Steven Piantadosi, Brigham and Women’s Hospital
- Vinay Puduvalli, University of Texas MD Anderson Cancer Center
- Rif Rahman, Dana-Farber Cancer Institute
- David Reardon, Dana-Farber Cancer Institute
- Erik Sulman, NYU Langone Medical Center
- Martin van den Bent, Erasmus MC Cancer Center
- Patrick Wen, Dana-Farber Cancer Institute
- Nicole Wilmarth, American Brain Tumor Association
Price
To register for the course, you will need to login into the Neuro-Oncology Academy and create a profile or login as a visitor. Once logged in, click "Register," then select one of following topic selections:
- Research Question Considerations
- What Kind of Trial and How Big
- How to Write a Protocol
Last step, click "Take Course."