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ForwardBasics of Clinical Trial Designs
2022 SNO Introduction to Clinical Trial Design and Protocol Development Workshop
The Society for Neuro-Oncology is pleased to announce the 4th Annual Introduction to Clinical Trial Design and Protocol Development Workshop. This year’s workshop will be held in person on Thursday, August 11, 2022 in Toronto, Canada, prior to the Conference on CNS Clinical Trials and Brain Metastases, Co-Sponsored by SNO and ASCO. New this year is an expanded offering to include an introductory protocol development option for participants without prior experience writing a clinical trial protocol or conducting clinical research.
Planning Committee:
- Stephen Bagley, University of Pennsylvania
- Susan Chang, University of California, San Francisco
- Maryam Fouladi, Nationwide Children’s Hospital
- Mustafa Khasraw, Duke University
- Annette Molinaro, University of California, San Francisco
- Ian Parney, Mayo Clinic
- Vinay Puduvalli, University of Texas MD Anderson Cancer Center
- Erik Sulman, NYU Langone Medical Center
- Patrick Wen, Dana-Farber Cancer Institute
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_SNO Clinical Trials Scholars Workshop 2022.pdf | 151.36 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.
1. Research Question Considerations:
- Fundamentals of Clinical Trial Design (Steven Piantadosi)
- The Research Question (Steven Piantadosi)
- Types of Trial Designs (Steven Piantadosi)
- Statistical Issues (trial design) (Annette Molinaro)
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)
- 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
- 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
- Reflections of Experienced Clinical Trialists (Mark Gilbert, Stuart Grossman, Minesh Mehta)
- Pediatric Trial Considerations (Maryam Fouladi)
- Bridging Academia and Industry (including funding) (Mustafa Khasraw)
- Nuts and Bolts of Developing an Investigator-Initiated Trials (Vinay Puduvalli)
Presenting Speakers:
- Terri Armstrong, National Cancer Institute
- Susan Chang, University of California, San Francisco
- Jennifer Clarke, University of California, San Francisco
- Tim Cloughesy, University of California, Los Angeles
- Maryam Fouladi, Nationwide Children’s Hospital
- Evanthia Galanis, 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
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."