How to Write a Protocol

How to write a protocol: 

Background (Mustafa Khasraw) NEW  

Endpoints (none) 


  • 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)  

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