AAOMS Clinical Trials Methods Course

Sponsored by the Oral and Maxillofacial Surgery Foundation, the Osteo Science Foundation and the Michigan Institute for Clinical and Health Research

Designed exclusively for:
  • Oral and Maxillofacial Surgeons, including faculty, residents, fellows and private practitioners interested in clinical research and trial design
  • OMS who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients

Provide a broad overview of research methodology and clinical trial design. Develop clinical trial proposals that can be submitted to funding organizations. Topics covered include:

  • Protocol Design
  • Hypothesis Testing
  • Selection of Outcome Measures
  • Study Design
  • Sample design/Sample Size Determination
  • Data Collection
  • Statistical Analysis
  • Budget Development
  • Patient Recruitment
  • Informed Consent
  • Inclusion/Exclusion Criteria
  • IRB Issues
  • Data Safety Monitoring

Palmer Commons University of Michigan, Ann Arbor, MI

Course Preparation

You will be assigned to a proposal development breakout group prior to the course date.

Your group will convene a conference call in early April to select a clinical trial proposal topic that will be developed at the course. Dates and times for each call are listed.

Breakout Group
Conference Call Date and Time
April 5, 2016, 6 pm Eastern Time
Group Leader
Gary F. Bouloux, DDS, MD
Emory University
Atlanta, GA

Breakout Group
Craniofacial Trauma
Conference Call Date and Time
April, 7, 2016 7:30 pm Eastern Time
Group Leader
Paul Tiwana, DDS, MD, MS
Southwestern University of Texas-Southwestern Medical Center
Dallas, TX

Breakout Group
Conference Call Date and Time
April, 7, 2016, 6pm Eastern Time
Group Leader
Joseph E. Cillo, Jr., DMD, MPH
Allegheny General Hospital
Pittsburgh, PA


Breakout Group
Conference Call Date and Time
April 6, 2016, 9pm Eastern Time
Group Leader
Jasjit K. Dillon, DDS, MD
University of Washington
Seattle, WA


Course Schedule

Wednesday, May 11, 2015

12:30 p.m. - 1:00 pm

1:00 p.m. – 1:30 p.m.
Opening Remarks

Louis K. Rafetto, DMD
2015-2016 AAOMS President
Wilmington, DE

Thomas B. Dodson, DMD, MPH
Chairman, OMS Foundation
Seattle, WA

Deepak Kademani, DMD, MD
Chairman, AAOMS Committee on Research Planning Technology and Assessment
Minneapolis, MN

Sean P. Edwards, DDS, MD
OMS Program Director, University of Michigan
Ann Arbor, MI

Brent Ward, DDS, MD, FACS
OMS Head and Neck Oncology Fellowship Director, University of Michigan
Ann Arbor, MI

1:30 p.m. – 2:30 p.m.
Overview of the Key Elements of Clinical Trial Design
Claire Kalpakjian, PhD, MS
University of Michigan
Physical Medicine and Rehabilitation
Posing a meaningful research question, turning your question into a testable hypothesis, and designing a clinical trial to answer your question and test your hypothesis.

2:30 p.m. – 3:30 p.m.
Errors in Clinical Trials
Meilan King Han MD
University of Michigan
Associate Professor, Department of Internal Medicine, Medical Director,
Women's Respiratory Health Program
Highlights mistakes that are commonly made in the conduct of clinical trials. These include errors in statistical methods and proper experimental design.

2:30 p.m. – 3:45 p.m.

3:45 p.m. – 4:45 p.m.
Statistical Concepts in Clinical Trials I
Ceib Phillips, MPH, PhD
University of North Carolina School of Dentistry
Professor, Orthodontics and Assistant Dean for Graduate and Advanced Education
The null hypothesis, rationale for randomization, sample size generation, power, statistical testing, and intent to treat analyses.

4:45 p.m. – 6:00 p.m.
Breakout Sessions

Palmer Commons Boardroom 1

Craniofacial Trauma
Palmer Commons Boardroom 2

Palmer Commons Boardroom 3

Palmer Commons Boardroom 4

6:30 p.m. – 8:00 p.m.
Reception and Dinner at Weber's Inn


Thursday, May 12, 2015

7:30 a.m. - 8:00 a.m. Breakfast

8:00 a.m. – 9:30 a.m.
Statistical Concepts in Clinical Trials II
Ceib Phillips, MPH, PhD
Tests of significance, multiple endpoints, stratification, repeated measurements, subgroup analyses, crossover problems

9:30 a.m. – 10:30 a.m.
Discussion on Research Ethics and Integrity
Alan R. Tait, Ph.D.
University of Michigan
Endowed Professor of Clinical Research, Department of Anesthesiology,
Center for Bioethics and Social Sciences in Medicine

Conducting ethical clinical trials and deviations from ethical standards are discussed.

10:30 a.m. – 12 Noon
Breakout Groups

12:00 p.m. – 1:00 p.m.

1:00 p.m. – 3:00 p.m.
Breakout Groups

3:00 p.m. – 3:15 p.m.

3:15 p.m. – 6:30 p.m.
Breakout Groups

6:30 p.m. - 8:00 p.m.
Working Dinner
Palmer Commons


Friday, May 13, 2015


7:30 a.m.-8:00 a.m.

8:00 a.m.-9:00 a.m.
Patient Selection
Lisa M. Connally
University of Michigan
Recruitment Coordinator
Recruiting issues and strategies, retaining subjects, inclusion and exclusion criteria and its impact on validity, stratification, randomization techniques and IRB approval

9:00 a.m. - 12:00 p.m.
Groups Present and Defend Proposals

12:00 p.m. – 12:15 p.m.
Closing Remarks

12:15 p.m.
Box Lunches Available

12:30 p.m.
Transportation Provided to Airport