Basics 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.

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

Course summary
Course opens: 
05/11/2022
Course expires: 
05/06/2027
Cost:
$0.00

Scholars Homework

Research Question Considerations:  

  • SP – Module 8 – Fundamentals – Research Question – Types of Trial designs 
  • Statistical issues (trial design) (Annette Molinaro – 2020 recorded)

What Kind of Trial and How Big: 

  • SP – Module 2– Therapeutic Development 
  • 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 (Eva Galanis) 
  • Phase III trials (Martin van den Bent) 
  • Novel Designs (umbrella, basket, platform, adaptive randomization external control (Rif Rahman) NEW  

How to write a protocol: 

  • Background (Mustafa Khasraw) NEW  
  • Endpoints (none) 

Eligibility 

  • Clinical trial accrual (David Reardon) 
  • Eligibility criteria (Eudocia Lee) 
  • Issues related to disparities (Shawn Hervey Jumper) 

SP – Module 5 – Cohort Issues 

Response assessment 

  • Response assessments and endpoints (Patrick Wen) Re-record 
  • Clinical Outcomes Assessment (Terri Armstrong) 

SP – Module 9 – Outcome Measures 

Correlative studies 

  • Correlative and biomarker studies. (Erik Sulman) 

Statistical issues  

  • SP – Module 6 – Bias 
  • SP – Module 10 – Precision and Sample Size 
  • SP – Module 11 – Basics of Analysis 
  • Interpreting trial data (Steven Piantadosi Recorded 2020) 

Regulatory issues 

  • PI Responsibilities and Regulatory Issues (Susan Chang) 
  • FDA perspective in neuro-oncology trials (Gautam Mehta) 

Ancillary issues: 

  • Reflections of experienced clinical trialists (What I wish I had known) (Gilbert, Grossman, Mehta) 
  • Pediatric Trial Considerations. (Maryam Fouladi) 
  • Bridging academia and industry (including funding) (Mustafa Khasraw) 
  • Nuts and Bolts of Developing an Investigator-Initiated Trial (Vinay Puduvalli) (including funding)  

 

 

 

 

 

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
 
Status
Price
Title
$0.00Included
Please login or register to take this course.
$0.00Included
Please login or register to take this course.
$0.00Included
Please login or register to take this course.
$0.00Included
Please login or register to take this course.

Price

Cost:
$0.00
Please login or register to take this course.

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."