July 21-27, 2012
Vail Marriott Mountain Resort & Spa
Vail, Colorado
Learning Objectives
Clinical Development and Concepts in Biostatistics
- The sequence of questions in a drug/device clinical development plan
- Safety monitoring at different stages of development
- Fundamental concepts in biostatistics and their place in the sequence of clinical
development
Phase I and Clinical Pharmacology
- Goals for Phase I
- Phase I populations
- Approaches to define dosage range: Analyses
- Phase I designs and approaches
- Use of toxicology studies to shape dosage range and safety surveillance
- Fundamentals of clinical pharmacology
Phase II, Endpoints, Biomarkers
- Goals for Phase II
- Choosing a study population
- Approaches to choosing clinical endpoints
- Phase II designs and analyses
- Use of biomarkers in Phase II
Phase III and Trial Implementation
- Elements needed for a Phase III trial
- Stopping/altering studies for safety or efficacy
- The clinical trial team
- Data management
- Realistic timelines, budgets
- Drug supply
- Barriers to recruitment
- Funding and reporting
Investigator Responsibilities, Ethics, and Regulatory
- GCP and investigator responsibilities, budget
- Informed consent and risk in early phase trials
- Regulatory requirements for IND/IDE and reporting requirements
Continuing Medical Education (TBD)
Clinical Trial Methods Course in Neurology 2012 Agenda
Saturday, July 21, 2012
| 8:00-1:00 |
Course Registration, Faculty and Participants register with course staff |
| 12:00-1:00 |
Faculty Orientation (Lunch) |
| 12:00-1:00 |
Lunch |
| 1:00-1:15 |
Introduction to the Course (Kieburtz & Ravina) |
| 1:15-1:30 |
Review of Materials, expectations, etc |
| 1:30-2:00 |
Lecture 1: The Changing Landscape for Pharmaceutical Innovation: Economic Challenges in CNS Product Development (Kaitin/Olanow) |
| 2:00-2:45 |
Lecture 2: Asking Questions: The Sequence of Clinical Development (O’Neill/Katz) |
| 2:45-3:00 |
Break |
| 3:00-3:45 |
Lecture 3: Ins/Outs of protocols: language/vocabulary (Blakely/Valadka) |
| 3:45-5:15 |
Protocol Development 1: Groups Meet (review submitted synopsis; Assign: revise for next session) |
| 5:15-6:00 |
Opening Reception |
| 6:00-8:00 |
Group Dinner (Outside weather permitting) |
Sunday, July 22, 2012
| 7:00-8:15 |
Group Breakfast |
| 8:15-8:45 |
From Vail to Trial (Erika Augustine/Kieburtz) |
| 8:45-9:30 |
Lecture 4: Fundamentals of Biostatistics (Parides/Elm) |
| 9:30-10:15 |
Lecture 5: Questions and Designs for Phase I Clinical Trials (Piantadosi/McDermott) |
| 10:15-10:30 |
Break |
| 10:30-11:15 |
Lecture 6: Clinical Pharmacology (Anderson/Venuto) |
| 11:15-12:00 |
Lecture 7: Goals and Designs for Phase II Clinical Trials (Cudkowicz/Lenz) |
| 12:00-1:00 |
Lunch |
| 1:00-1:45 |
Lecture 8: CRM Workshop (Piantadosi) |
| 1:45-4:00 |
Protocol Development 2: What Is Your Primary Question? (Assign: edit synopsis to submit 3rd session) |
| 4:00-4:15 |
Break (as needed, snacks) |
| 4:15-5:45 |
Independent Study/Individual Sessions/Free Time |
| 6:00-7:45 |
Group Dinner |
Monday, July 23, 2012
| 7:00-8:00 |
Group Breakfast |
| 8:00-8:45 |
Lecture 9: Statistical Considerations to Phase II Clinical Trials (McDermott/Kryscio) |
| 8:45-9:30 |
Lecture 10: Adaptive designs in Phase I-II Clinical Trials (Clarke/McDermott) |
| 9:30-9:45 |
Break |
| 9:45-10:30 |
Lecture 11: Endpoints and Outcome Measures (Shefner) |
| 10:30-11:15 |
Lecture 12: Biomarkers in Clinical Development (Cedarbaum/Olanow) |
| 11:15-12:00 |
Lecture 13: FDA 101 - What do you need for an IND (Katz/Kieburtz) |
| 12:00-1:00 |
Lunch (all others) |
| 12:00-1:00 |
Working lunch (Faculty): update meeting |
| 1:00-1:45 |
Lecture 14: FDA Regulation of Medical Devices (Como/Valadka) |
| 1:45-4:00 |
Protocol Development 3: Focus on General Design (review assignment; Assign: revise analysis approach for next session) |
| 3:45-4:15 |
Break as needed (snacks) |
| 4:00-5:30 |
Independent study/Free time/sign up to meet with faculty |
| 5:30 |
Dinner on own |
Tuesday, July 24, 2012
| 7:00-8:00 |
Group Breakfast |
| 8:00 |
Updated Protocol Synopsis Due |
| 8:00-8:45 |
Lecture 15: Safety Monitoring Across Clinical Development (Kieburtz/Haley) |
| 8:45-9:30 |
Lecture 16: Approaches to Data Monitoring for Safety and Efficacy (Elm/Clarke) |
| 9:30-9:45 |
Break |
| 9:45-10:30 |
Lecture 17: Ethical Trials & Neurological Disorders: Intro into Phase I-II Clinical Trials (Kimmelman/Ravina) |
| 10:30-11:15 |
Lecture 18: Recruitment, Retention and Special Populations (Bell/Cudkowicz) |
| 11:15-12:30 |
Protocol Development 4: Focus on endpoints and analysis plan |
| 12:30-1:30 |
Lunch |
| 1:30-4:30 |
Independent Study/Free time/sign up to meet with faculty Dinner on own |
| Dinner on own |
Wednesday, July 25, 2012
| 7:00-8:00 |
Group Breakfast |
| 8:00-9:30 |
Protocol Development 5: Focus on safety issues and recruitment |
| 9:30-9:45 |
Break |
| 9:45-10:30 |
Lecture 19: Clinical Trial Budgets and Practicalities of Operations (Kamp/Lenz) |
| 10:30-11:15 |
Lecture 20: Understanding the Basics Good Clinical Practices and Investigator Responsibilities (Kayson/Poole) |
| 11:15-11:30 |
Break |
| 11:30-12:00 |
Lecture 21: Contracts, Conflicts, and Confidentiality (Shinaman/Kayson) |
| 12:00-12:30 |
Lecture 22: Attributes of a Good Clinical Trials Site (Cedarbaum/Kamp) |
| 12:30-1:30 |
Lunch |
| 1:30-4:00 |
Independent Study (all faculty available) |
| 4:00 |
Final Protocols Due |
| Dinner on own |
Thursday, July 26, 2012
| 7:00-8:00 |
Group Breakfast |
| 8:00-8:30 |
Lecture 23 A: Funding Opportunities for Clinical Trials: NIH (Moy/Ravina) |
| 8:30-9:00 |
Lecture 23 B: Funding Opportunities for Clinical Trials: Other Sources (Schwarzschild/Moy) |
| 9:00-9:45 |
Lecture 24: Are we there yet? What You Need for a Phase III Clinical Trial (Garofalo/Kamp) |
| 9:45-10:00 |
Break |
| 10:00-11:30 |
Protocol Development 6: Feedback from Faculty on Protocols, 15 minute sessions will be scheduled with each participant to meet with the faculty of your protocol development team |
| 11:30-12:00 |
Group photo |
| 12:00-1:00 |
Lunch |
| 1:00-1:30 |
Feedback from Trainees |
| 1:30-2:15 |
Faculty Meeting |
| 2:15-4:15 |
Participants Complete Course Questionnaires |
| 4:15-4:45 |
Closing |
| 5:00-6:00 |
Reception |
| 6:00-8:00 |
Group Dinner |
Friday, July 27, 2012
| 7:00-8:00 |
Group Breakfast/Departures |
APPLICATIONS DUE BY 4/20/2012 at 5:00PM EST
ACCEPTED PARTICIPANTS WILL RECEIVE FULL SCHOLARSHIPS FOR TUITION AND EXPENSES
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Supported by the National Institute of Neurological Disorders and Stroke |
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