August 16-22, 2010
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
Accreditation
The University of Rochester School of Medicine and Dentistry is accredited by the
Accreditation Council for Continuing Medical Education to provide continuing medical
education for physicians.
Certification
The University of Rochester School of Medicine and Dentistry designates this educational
activity for a maximum of
37.75 AMA PRA Category 1 credits™. Physicians should
only claim credit commensurate with the extent of the participation in the activity.
Preliminary Course Agenda
Monday August 16, 2010
| 12:00-4:00 |
Course Registration, Faculty and Participants register with course staff |
| 4:30-5:30 |
Faculty Orientation |
| 5:30-6:15 |
Opening Reception |
| 6:15-6:30 |
Welcome (Ravina) |
| 6:30-7:30 |
Reception and Dinner (Outside weather permitting) |
Tuesday August 17, 2010
| 7:00-8:00 |
Group Breakfast |
| 8:00-8:15 |
Introduction to the Course (Ravina) |
| 8:15-8:30 |
From Vail to Trial: the EPITOME story (Benatar) |
| 8:30-9:15 |
Lecture 1: Asking Questions: The Sequence of Clinical Development (Poole,
Ravina) |
| 9:15-10:00 |
Lecture 2: Fundamentals of Biostatistics (Parides, Clarke) |
| 10:00-10:15 |
Break |
| 10:15-11:00 |
Lecture 3: Questions and Designs for Phase I Clinical Trials (Piantadosi, Poole) |
| 11:00-11:45 |
Lecture 4: Clinical Pharmacology I (Edwards, Fagan) |
| 11:45-12:45 |
Lunch |
| 12:45-3:15 |
Protocol Development 1: What Is Your Primary Question? (Break as needed, snacks
delivered to individual break out sessions at 2:00) |
| 3:15-6:00 |
Independent Study/Individual Sessions/Free Time |
| 6:00 |
Dinner on own |
Wednesday August 18, 2010
| 7:00-8:00 |
Group Breakfast |
| 8:00-8:45 |
Lecture 5: Questions and Designs for Phase II Clinical Trials (Cudkowicz, Ravina) |
| 8:45-9:30 |
Lecture 6 A: Statistical Approaches to Phase II Clinical Trials (McDermott, Coffey) |
| 9:30-9:45 |
Break |
| 9:45-10:30 |
Lecture 6 B: Adaptive designs in Phase I-II Clinical Trials (Coffey, McDermott) |
| 10:30-11:15 |
Lecture 7: Clinical Pharmacology II (Fagan, Edwards) |
| 11:15-11:30 |
Break |
| 11:30-12:15 |
Lecture 8: Endpoints and Outcome Measures (Shefner, Holloway) |
| 12:15-1:15 |
Lunch/Faculty update meeting |
| 1:15-2:00 |
Lecture 9: FDA 101 - What you need for an IND (Katz, Kieburtz) |
| 2:00-2:45 |
Lecture 10: Development paradigms for non pharmacological therapies (Nahin, Cudkowicz) |
| 2:45-3:00 |
Break |
| 3:00-5:00 |
Protocol Development 2: Focus on General Design |
| 5:00-6:00 |
Independent study/Free time/sign up to meet with faculty |
| 6:00 |
Group Dinner |
Thursday August 19, 2010
| 7:00-8:00 |
Group Breakfast |
| 8:00 |
Updated Protocol Synopsis Due |
| 8:00-8:45 |
Lecture 11: Biomarkers and Lab Correlates (McArthur, Deveber) |
| 8:45-9:30 |
Lecture 12: Safety Monitoring Across Clinical Development (Kieburtz, Haley) |
| 9:30-9:45 |
Break |
| 9:45-10:30 |
Lecture 13: Ethical Issues in Phase I-II Clinical Trials (Kim, Holloway) |
| 10:30-11:15 |
Lecture 14: Are we there yet? What You Need for a Phase III Clinical Trial (Haley,
Cutter) |
| 11:15-11:30 |
Break |
| 11:30-12:15 |
Lecture 15: Approaches to Data Monitoring for Safety and Efficacy (Cutter,
Palesch) |
| 12:15-1:15 |
Lunch |
| 1:15-2:45 |
Protocol Development 3: Focus on endpoints and analysis plan |
| 2:45-4:30 |
Independent Study/Free time/sign up to meet with faculty |
| 4:30-6:30 |
Career Development Session (Johnston, McArthur, Furie, Benatar) |
| 7:00 |
Group Dinner and Round Table Discussion: Careers in Clinical Trials (Moderators - Johnston: Presenters - Poole, Katz, Cudkowicz, Kieburtz) |
Friday August 20, 2010
| 7:00-8:00 |
Group Breakfast |
| 8:00-8:45 |
Lecture 16: Trials and Tribulations: the experience of a “young” (but balding)
clinical trialist (Benatar, TBD) |
| 8:45-9:30 |
Lecture 17: Project and Data Management: What it takes to run a Trial (Kamp, Cudkowicz) |
| 9:30-10:15 |
Lecture 18: Good Clinical Practices and Investigator Responsibilities (Kayson, Kamp) |
| 10:15-10:30 |
Break |
| 10:30-11:15 |
Lecture 19: Clinical Trial Budgets and Administration (Kamp, Piantadosi) |
| 11:15-12:00 |
Lecture 20: Contracts, Conflicts, and Confidentiality (Shinaman, Piantadosi) |
| 12:00-1:00 |
Lunch |
| 1:00-1:45 |
Lecture 21: Recruitment, Retention and Special Populations (Bell, Furie) |
| 1:45-2:30 |
Protocol Development 4: Focus on safety issues and lab surveillance |
| 2:30-5:00 |
Independent Study (all faculty available) |
| 5:00 |
Final Protocols Due
Dinner on own |
Saturday August 21, 2010
| 7:00-8:00 |
Group Breakfast |
| 8:00-8:30 |
Lecture 22 A: Funding Opportunities for Clinical Trials: NIH (Moy, Kieburtz) |
| 8:30-9:00 |
Lecture 22 B: Funding Opportunities for Clinical Trials: Other Sources (Furie, Ravina) |
| 9:00-9:15 |
Break |
| 9:15-10:00 |
Lecture 23: Clinical Trial Reporting (Palesch) |
| 10:00-11:15 |
Protocol Development 5: Feedback from Faculty on Protocols, 15 minute sessions will be scheduled with each participant to meet with the faculty of your protocol development team |
| 11:15-12:15 |
Lunch (group photo) |
| 12:15-12:45 |
Feedback from Trainees |
| 12:45-1:30 |
Faculty Meeting/Participants Complete Course Questionnaires |
| 1:30-2:00 |
Closing |
| 3:15- |
Free time/Dinner on own |
Sunday August 22, 2010
| 7:00-8:00 |
Group Breakfast |
APPLICATIONS DUE BY 3/26/2010
ACCEPTED PARTICIPANTS WILL RECEIVE FULL SCHOLARSHIPS FOR TUITION AND EXPENSES
|
Supported by the National Institute of Neurological Disorders and Stroke |
|