How to Write a Protocol

How to Write a Protocol: 

Background and Rationale (Mustafa Khasraw) 


  • Clinical Trial Accrual (David Reardon)  (18:36) 
  • Eligibility Criteria (Eudocia Quant Lee) (8:42) 
  • Issues Related to Disparities (Shawn Hervey Jumper) (19:49) 
  • Cohort Issues, Part A  (Steven Piantadosi)  
  • Cohort Issues, Part B  (Steven Piantadosi)   
  • Cohort Issues, Part C  (Steven Piantadosi)  
  • Improving Representation in Brain Tumor Clinical Trials (Joshua Budhu, Ugonma Chukwueke) 

Response Assessment  

  • Response Assessments and Endpoints (Patrick Wen)  
  • Clinical Outcomes Assessment (Terri Armstrong) (16:58) 
  • 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)  (22:40) 

 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) (18:16) 
  • FDA Perspective in Neuro-oncology Trials (Gautam Mehta) (13:43) 

 Ancillary Issues 

  • Pediatric Trial Considerations (Maryam Fouladi) (19:06) 
  • Bridging Academia and Industry (including funding) (Mustafa Khasraw) (18:36) 
  • Nuts and Bolts of Developing an Investigator-Initiated Trials (Vinay Puduvalli) (18:38)
  • Patient Advocacy in Clinical Trials (Nicole Wilmarth) 
  • Reflections of Experienced Clinical Trialists (Mark Gilbert, Stuart Grossman, Minesh Mehta)  (30:40) 
Course summary
Course opens: 
Course expires: 


Please login or register to take this course.

You must click the "Take Course" button to view the videos in this section.