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Wednesday, April 29, 2020

12:30 – 1 p.m.
Registration (snacks and beverages available)

1 – 1:30 p.m. 
Opening Remarks
Victor L. Nannini, DDS, FACS, AAOMS President
William C. Passolt, OMS Foundation Chair 
Sean P. Edwards, DDS, MD, FACS, Course Director
Michael Miloro, DMD, MD, FACS, Course Director

1:30 – 2:30 p.m.
Overview of the Key Elements of Clinical Trial Design
This session will address how to pose a meaningful research question, turn a question into a testable hypothesis as well as design a clinical trial to answer a question and test a hypothesis.
Lyndon F. Cooper, DDS, PhD
Associate Dean for Research, Head of Department of Oral Biology
University of Illinois at Chicago College of Dentistry

2:30 – 3:30 p.m.
Regulatory Compliance in Research Design
Regulatory compliance with drugs, devices, Medicare and Medicaid billing, Medicare’s clinical trial policy and device policy and human subjects’ protections are critical issues in research design.
Lisa Pitler, MS, JD, RN
Managing Director
Advarra Consulting

3:30 – 4:30 p.m.
Data Storage and Management
Safe and secure maintenance of appropriate records is critical during the clinical trial as well as after completion of the study.
Clark M. Stanford, DDS, PhD
Distinguished Professor and Dean
University of Illinois at Chicago College of Dentistry

4:30 – 6 p.m. 
Breakout sessions
Course statisticians: Charles LeHew, PhD; and Ceib Phillips, MPH, PhD
Dentoalveolar/anesthesia: TBD, member of CRPTA
TMD/facial pain: Gary Bouloux, DDS, MD, MDSc, FRACDS, FACS
Pathology/reconstruction: TBD, member of CRPTA
Craniofacial trauma/orthognathic/facial deformities: Michael Markiewicz, DDS, MD, MPH  

6:30 – 8 p.m. 
Dinner
Groups continue work on their proposals after dinner.

Thursday, April 30, 2020

7:30 – 8 a.m.
Breakfast     

8 – 9 a.m. 
Statistical Concepts in Clinical Trials I
The null hypothesis, rationale for randomization, sample size generation, power, statistical testing and intent to treat analyses will be discussed.
Ceib Phillips, MPH, PhD
University of North Carolina 

9 – 10 a.m.  
Statistical Concepts in Clinical Trials II
Tests of significance, multiple endpoints, stratification, repeated measurements, subgroup analyses and crossover problems will be reviewed.
Ceib Phillips, MPH, PhD
Associate Dean and Professor
University of North Carolina School of Dentistry

10 – 11 a.m.
Discussion on Research Ethics and Integrity
Ethical clinical trials and deviations from ethical standards will be discussed.
Stephanie Guzik, MBA, BSN, RN
Associate Vice President, Research Compliance and Conflict of Interest
Research Integrity Officer
Rush University

11 a.m. – noon
Errors in Clinical Trials
This session will highlight mistakes commonly made in the conduct of clinical trials. These include errors in statistical methods and proper experimental design.
Lisa Anderson-Shaw, DPH, MA, MSN
Clinical Ethics Consultant
University of Illinois Medical Center

Noon – 1 p.m.
Lunch 

1 – 6 p.m.
Breakout groups 

6 – 8 p.m. 
Dinner
Groups continue work on their proposals after dinner.

Friday, May 1, 2020

7:30 – 8 a.m.
Breakfast    

8 – 9 a.m. 
Patient Selection for Clinical Trials
This session will cover recruiting issues and strategies, retention of subjects, inclusion and exclusion criteria and impact on validity, stratification, randomization techniques and institutional review board approval.     
Michael R. Markiewicz, DDS, MD, MPH
Cleft and Craniofacial Team Codirector
Craniofacial Center of Western New York
Professor and Chair
University of Buffalo School of Dental Medicine Department of Oral and Maxillofacial Surgery

9 a.m. – noon
Groups present and defend proposals