August 17-24, 2008
Vail Marriott Mountain Resort & Spa
Vail, Colorado
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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
  • 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 57.75 AMA PRA Category 1 credits™. Physicians should only claim credit commensurate with the extent of the participation in the activity.

Preliminary Course Agenda for Year 1

Sunday August 17, 2008

 
12:00-4:00 Arrivals and Registration
4:00-5:00 Faculty Orientation
5:00-5:30 Welcome and Introduction to the Course and Faculty (Ravina, Moy)
5:30-6:15 Lecture 1: Asking Questions: The Sequence of Clinical Development (Poole, Kieburtz)
6:30 Reception and Dinner
   

Monday August 18, 2008

 
7:00-8:00 Group Breakfast
8:00-8:45 Lecture 2: Fundamentals of Biostatistics: Statistical Approaches to Clinical Development (Piantadosi, McDermott)
8:45-9:30 Lecture 3: Questions and Designs for Phase I Clinical Trials (Bozik, Poole)
9:30-10:15 Lecture 4: Statistical Issues in Phase I Designs (Gonin, Piantadosi)
Break
10:30-12:00 Small Group Discussion 1:
Designs for Phase I Clinical Trials
Group 1: Bozik, Piantadosi
Group 2: Poole, Gonin
12:00-12:45 Lunch
12:45-2:45 Protocol Development 1: What Is Your Primary Question?
Break
3:00-3:45 Lecture 5: Toxicology and Safety Issues in Phase I (TBD)
3:45-4:30 Lecture 6: Clinical Pharmacology I (Edwards, Fagan)
4:30-6:30 Independent Study – Work on Clinical Development Plan
6:30- Group Dinner and Dinner Program: Clinical development - Experiences from Vascular Devices (Becker - speaker, Haley discussant)
   

Tuesday August 19, 2008

 
7:00-8:00 Group Breakfast
8:00 Clinical Development Plan outlines due
8:00-8:45 Lecture 7: Questions and Designs for Phase II Clinical Trials (Cudkowicz, Ravina)
8:45-9:30 Lecture 8 A: Statistical Approaches to Phase II Clinical Trials (McDermott, Coffey)
9:30-10:15 Lecture 8 B: Statistical Approaches to Phase II Clinical Trials (Coffey, McDermott)
Break
10:30-11:15 Lecture 9: Clinical Pharmacology II (Fagan, Edwards)
11:15-12:30 Small Group Discussion 2: Approaches to Phase II Clinical Trials
Group 1: McDermott, Ravina
Group 2: Coffey, Cudkowicz
12:30-1:15 Lunch
1:15-2:00 Lecture 10: Endpoints and Study Populations in Phase II (Holloway, Johnston)
2:00-3:30 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
Break
3:45-5:15 Protocol Development 2: Focus on Phase I and II Designs
5:15-7:00 Work on Protocol Synopsis
7:00 Protocol Synopses Due
  Dinner on own
   

Wednesday August 20, 2008

 
7:00-8:00 Group Breakfast
8:00-8:45 Lecture 11: Biomarkers and Lab Correlates (McArthur, DeKosky, Becker)
8:45-9:30 Lecture 12: FDA 101 - what you need for an IND (Katz)
9:30-10:15 Lecture 13: Safety Monitoring Across Clinical Development (Kieburtz, Haley)
Break
10:30-11:15 Lecture 14: Ethical Issues in Phase I-II Clinical Trials (Kim, Holloway)
11:15-12:45 Small Group Discussion 4: Biomarkers and clinical measurement
Group 1: Johnston, DeKosky, McDermott
Group 2: McArthur, Holloway, Coffey
12:45-1:30 Lunch
1:30-3:30 Protocol Development 3: Review Protocol Synopses
3:30-6:30 Work on Protocol /Synopsis
6:30 Group Dinner and Round Table Discussion: Careers in Clinical Trials
(Moderators - Johnston and Ravina: Presenters - Poole, Bozik, Marler, Cudkowicz, Shoulson)
   

Thursday August 21, 2008

 
7:00-8:00 Group Breakfast
8:00-8:45 Lecture 15: Are we there yet? What You Need for a Phase III Clinical Trial (Haley, Moy)
8:45-9:30 Lecture 16: Approaches to Data Monitoring for Safety and Efficacy (Gilbert, McDermott)
9:30-10:15 Lecture 17: Project and Data Management: What it takes to Run a Trial (Kamp, Cudkowicz)
Break
10:30-11:15 Lecture 18: Contracts, Conflicts, and Confidentiality (Shinaman, Johnston)
11:15-12:45 Small Group Discussion 5: Issues in Data Monitoring and Study Management
Group 1: Marler, Gilbert, Kamp
Group 2: Shouldson, McDermott, Moy
12:45-1:30 Lunch
1:30-3:30 Protocol Development 4: Focus on endpoint selection and analysis plan
Trial
3:30- Independent Study
  Dinner on own
   

Friday August 22, 2008

 
7:00-8:00 Group Breakfast
8:00-8:45 Lecture 19: Recruitment, Retention and Special Populations (Bell, Glauser)
8:45-9:30 Lecture 20: Good Clinical Practices and Investigator Responsibilities (Kayson, Kamp)
Break
9:45-11:45 Protocol Development 5: Focus on Safety Issues and Lab surveillance
11:45-12:30 Lunch
12:30-6:00 Work on Protocols and Consent Documents
6:00 Protocols and Informed Consent Documents Due
  Dinner on Own
   

Saturday August 23, 2008

 
7:00-8:00 Group Breakfast
8:00-8:45 Lecture 21: Funding Opportunities for Clinical Trials (Moy, Shoulson)
8:45-9:30 Lecture 22: Clinical Trial Reporting (Shoulson, Marler)
Break  
9:45-10:15 Trainee Completed Course Questionnaires
10:15-11:00 Feedback from Trainees in Small Group Format
11:00-12:30 Individual Feedback from Faculty on Protocols and Consent Forms
12:30-1:15 Lunch
1:15-4:00 Individual Feedback from Faculty on Protocols and Consent Forms
4:00-5:00 Faculty Meeting for Course Evaluations
5:00-6:00 Program Committee Meeting Review of Course Evaluations
7:00 Banquet and group photo
   

Sunday August 24, 2008

 
7:00-8:00 Group Breakfast
  Departures

APPLICATIONS DUE BY 3/28/2008
ACCEPTED PARTICIPANTS WILL RECEIVE FULL SCHOLARSHIPS FOR TUITION AND EXPENSES

Supported by the National Institute of Neurological Disorders and Stroke NINDS Logo


Jointly Sponsored by:
UR Sponsorship