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.
The University of Rochester School of Medicine and Dentistry designates this educational
activity for a maximum of
. Physicians should
only claim credit commensurate with the extent of the participation in the activity.
Sunday August 17, 2008
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12:00-4:00
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Arrivals and Registration
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4:00-5:00
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Faculty Orientation
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5:00-5:30
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Welcome and Introduction to the Course and Faculty (Ravina, Moy)
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5:30-6:15
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Lecture 1: Asking Questions: The
Sequence of Clinical Development (Poole, Kieburtz)
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6:30
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Reception and Dinner |
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Monday August 18, 2008
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7:00-8:00
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Group Breakfast
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8:00-8:45
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Lecture 2: Fundamentals of Biostatistics:
Statistical Approaches to Clinical Development (Piantadosi, McDermott)
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8:45-9:30
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Lecture 3: Questions and Designs
for Phase I Clinical Trials (Bozik, Poole)
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9:30-10:15
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Lecture 4: Statistical Issues in
Phase I Designs (Gonin, Piantadosi)
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Break
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10:30-12:00
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Small Group Discussion 1:
Designs for Phase I Clinical Trials
Group 1: Bozik, Piantadosi
Group 2: Poole, Gonin |
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12:00-12:45
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Lunch
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12:45-2:45
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Protocol Development 1: What Is
Your Primary Question?
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Break
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3:00-3:45
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Lecture 5: Toxicology and Safety
Issues in Phase I (TBD)
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3:45-4:30
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Lecture 6: Clinical Pharmacology
I (Edwards, Fagan)
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4:30-6:30
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Independent Study – Work on Clinical Development Plan
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6:30-
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Group Dinner and Dinner Program: Clinical development - Experiences from
Vascular Devices (Becker - speaker, Haley discussant) |
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Tuesday August 19, 2008
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7:00-8:00
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Group Breakfast
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8:00
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Clinical Development Plan outlines due
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8:00-8:45
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Lecture 7: Questions and Designs
for Phase II Clinical Trials (Cudkowicz, Ravina)
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8:45-9:30
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Lecture 8 A: Statistical Approaches
to Phase II Clinical Trials (McDermott, Coffey)
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9:30-10:15
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Lecture 8 B: Statistical
Approaches to Phase II Clinical Trials (Coffey, McDermott)
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Break
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10:30-11:15 |
Lecture 9: Clinical Pharmacology
II (Fagan, Edwards) |
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11:15-12:30 |
Small Group Discussion 2: Approaches
to Phase II Clinical Trials
Group 1: McDermott, Ravina
Group 2: Coffey, Cudkowicz |
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12:30-1:15 |
Lunch
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1:15-2:00 |
Lecture 10: Endpoints and Study
Populations in Phase II (Holloway, Johnston)
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2:00-3:30
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Small Group Discussion 3: Applications
of Clinical Pharmacology in Phase I and II Clinical Trials
Group 1: Fagan, Poole, Cudkowicz
Group 2: Edwards, Bozik, Ravina |
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Break
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3:45-5:15
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Protocol Development 2: Focus on
Phase I and II Designs
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5:15-7:00
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Work on Protocol Synopsis |
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7:00
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Protocol Synopses Due
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Dinner on own
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Wednesday August 20, 2008
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7:00-8:00
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Group Breakfast |
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8:00-8:45
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Lecture 11: Biomarkers and Lab Correlates
(McArthur, DeKosky, Becker)
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8:45-9:30
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Lecture 12: FDA 101 - what you need
for an IND (Katz)
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9:30-10:15
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Lecture 13: Safety Monitoring Across
Clinical Development (Kieburtz, Haley)
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Break
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10:30-11:15
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Lecture 14: Ethical Issues in Phase
I-II Clinical Trials (Kim, Holloway)
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11:15-12:45
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Small Group Discussion 4:
Biomarkers and clinical measurement
Group 1: Johnston, DeKosky, McDermott
Group 2: McArthur, Holloway, Coffey
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12:45-1:30
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Lunch
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1:30-3:30
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Protocol Development 3: Review Protocol
Synopses
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3:30-6:30
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Work on Protocol /Synopsis |
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6:30
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Group Dinner and Round Table Discussion: Careers in Clinical Trials
(Moderators - Johnston and Ravina: Presenters - Poole, Bozik, Marler, Cudkowicz,
Shoulson)
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Thursday August 21, 2008
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7:00-8:00
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Group Breakfast
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8:00-8:45
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Lecture 15: Are we there yet? What
You Need for a Phase III Clinical Trial (Haley, Moy)
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8:45-9:30
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Lecture 16: Approaches to Data Monitoring
for Safety and Efficacy (Gilbert, McDermott)
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9:30-10:15
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Lecture 17: Project and Data
Management: What it takes to Run a Trial (Kamp, Cudkowicz)
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Break
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10:30-11:15
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Lecture 18: Contracts,
Conflicts, and Confidentiality (Shinaman, Johnston) |
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11:15-12:45
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Small Group Discussion 5: Issues
in Data Monitoring and Study Management
Group 1: Marler, Gilbert, Kamp
Group 2: Shouldson, McDermott, Moy |
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12:45-1:30
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Lunch
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1:30-3:30
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Protocol Development 4: Focus on
endpoint selection and analysis plan
Trial
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3:30-
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Independent Study
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Dinner on own
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Friday August 22, 2008
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7:00-8:00
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Group Breakfast
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8:00-8:45
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Lecture 19: Recruitment, Retention
and Special Populations (Bell, Glauser)
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8:45-9:30 |
Lecture 20: Good Clinical
Practices and Investigator Responsibilities (Kayson, Kamp) |
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Break
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9:45-11:45
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Protocol Development 5: Focus on
Safety Issues and Lab surveillance
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11:45-12:30 |
Lunch |
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12:30-6:00
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Work on Protocols and Consent Documents |
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6:00
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Protocols and Informed Consent Documents Due
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Dinner on Own
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Saturday August 23, 2008
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7:00-8:00
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Group Breakfast
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8:00-8:45
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Lecture 21: Funding Opportunities
for Clinical Trials (Moy, Shoulson)
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8:45-9:30
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Lecture 22: Clinical Trial Reporting
(Shoulson, Marler)
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Break
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9:45-10:15
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Trainee Completed Course Questionnaires
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10:15-11:00
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Feedback from Trainees in Small Group Format
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11:00-12:30
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Individual Feedback from Faculty on Protocols and Consent Forms
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12:30-1:15
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Lunch
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1:15-4:00
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Individual Feedback from Faculty on Protocols and Consent Forms
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4:00-5:00
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Faculty Meeting for Course Evaluations
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5:00-6:00
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Program Committee Meeting Review of Course Evaluations
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7:00
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Banquet and group photo
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Sunday August 24, 2008
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7:00-8:00
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Group Breakfast
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Departures |