How to Write a Protocol: 

Background and Rationale (Mustafa Khasraw) (Scholars Workshop_Slide background on SharePoint) 

 Eligibility  

• 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)  

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   

• 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 

• Reflections of Experienced Clinical Trialists (Mark Gilbert, Stuart Grossman, Minesh Mehta)  (30:40) 
• 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)