How to Write a Protocol
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)