header__brand

Course overview

The course is open to oral and maxillofacial surgeons – including residents, fellow, faculty and private practitioners – with an interest in study design. More specifically, it is intended for OMSs interested in designing a clinical trial and developing a study protocol. It also will be of value to practitioners 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. Ideally, a resident and a faculty mentor pair will attend the course. Residents also will have the opportunity to interact with course faculty and faculty from other programs. A limited number of dental students who have been accepted into an OMS residency program or those who have a strong interest in attending an OMS residency program also are invited to register.

Course Sponsors: American Association of Oral and Maxillofacial Surgeons, Oral and Maxillofacial Surgery Foundation, University of Illinois at Chicago

Course Directors:  Sean P. Edwards, DDS, MD; and Michael Miloro, DMD, MD, FACS

There is no registration fee. Meals will be provided. CME/CDE will be available for participants.

Who should attend?

Oral and maxillofacial surgeons, including faculty, residents, fellows and private practitioners, interested in clinical research and trial design.

OMSs 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.

What’s new?

AAOMS has convened a clinical trials methods course at the University of Michigan biennially since 2008. The Board approved convening the 2018 course in Rosemont. The course will provide a broad overview of research methodology and clinical trial design as faculty members from the Chicagoland area give a new perspective. 

Topics and course information

Develop clinical trial proposals that can be submitted to funding organizations. Topics will include:

  • Protocol design
  • Hypothesis testing
  • Selection of outcome measures
  • Study design
  • Sample design/sample size determination
  • Data collection
  • Data storage and management
  • Statistical analysis
  • Budget development
  • Patient recruitment
  • Informed consent
  • Inclusion/exclusion criteria
  • IRB issues
  • Data safety monitoring
  • Regulatory compliance

Course objectives

The Clinical Trials Methods course objective is to provide an overview of clinical trial design with a focus on the Phase 3 trial. The National Cancer Institute defines a Phase 3 trial as “a study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects).” The course will combine both lectures and breakout sessions where participants will, under the guidance of the course faculty, design a clinical trial for a pre-assigned topic. The designs will include statistical methods, a budget, potential funding sources and a publication plan. At the end of the course, each group will present and defend its study design. Each group’s study design will be evaluated and scored by course faculty. Each attendee will be assigned to a proposal development breakout group prior to the course date. Each group will convene on a conference call in early April to select a clinical trial proposal topic that will be developed at the course. The breakout groups and their leaders include:

  • Dentoalveolar/Anesthesia: Joseph Cillo Jr., DMD, MPH, PhD, FACS
  • TMD/Facial Pain: Gary Bouloux, DDS, MD, MDSc, FRACDS, FACS
  • Pathology/Reconstruction: Jasjit Dillon, DDS, MD, BDS, FDSRCS
  • Craniofacial Trauma/Orthognathic/Facial Deformities: Michael Markiewicz, DDS, MD, MPH

Preliminary schedule

Day 1:  Wednesday, May 9

12:30 – 1 p.m.
Registration (Snacks and Beverages available)


1 – 1:30 p.m. 
Opening Remarks

Brett Ferguson, DDS, AAOMS President
Kathy Banks, DMD, OMSF Chair
Sean P. Edwards, DDS, MD
Michael Miloro, DMD, MD, FACS


1:30 – 2:30 p.m.
Overview of the Key Elements of Clinical Trial Design:

Posing a meaningful research question, turning a question into a testable hypothesis, and designing a clinical trial to answer a question and test a hypothesis.   

Lyndon F. Cooper, DDS, PhD
Associate Dean for Research
Department Head, 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, JD, MS, RN
Assistant Vice Chancellor
University of Illinois at Chicago


3:30 – 4:30 p.m.
Data Storage and Management:

Maintaining appropriate records safely and securely 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 College of Dentistry


4:30 – 6 p.m.
Breakout Sessions:

Course Statisticians: Charles LeHew, University of Illinois; Ceib Phillips, MPH, PhD

  • Dentoalveolar/Anesthesia: Joseph E. Cillo, Jr., DMD, MPH
  • TMD/Facial Pain: Gary Bouloux, DDS, MD
  • Pathology/Reconstruction: Jasjit K. Dillon, DDS, MD
  • Craniofacial Trauma/Orthognathic/Facial Deformities: Michael Markiewicz, DDS, MD, PhD 


6:30 – 8 p.m.
Reception and Dinner

Groups continue work on proposals after dinner. 

 

Day 2:  Thursday, May 10

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.

Ceib Phillips, MPH, PhD


9 – 10 a.m.  
Statistical Concepts in Clinical Trials II:

Tests of significance, multiple endpoints, stratification, repeated measurements, subgroup analyses, crossover problems.

Ceib Phillips, MPH, PhD

 

10 – 11 a.m.
Discussion on Research Ethics and Integrity:

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

Stephanie Guzik, MBA, BSN, RN
Director of Research Compliance
Research Integrity Officer
Rush University Medical Center

 

11 a.m. - noon
Errors in Clinical Trials


Highlights mistakes that are commonly made in the conduct of clinical trials. These include errors in
statistical methods and proper experimental design.

Arkadiusz Dudek, MD, PhD
Professor of Medicine
Director, Oncology Clinical Trials Office
University of Illinois at Chicago


Noon – 1 p.m.
Lunch


1 – 6 p.m. 
Breakout Groups 


6 – 8 p.m.
Dinner

Groups continue work on their proposals after dinner.

 

Day 3:  Friday, May 11

7:30 – 8 a.m.  
Breakfast
    


8 – 9 a.m.  
Patient Selection for Clinical Trials:

Recruiting issues and strategies, retaining subjects, inclusion and exclusion criteria and its impact on validity, stratification, randomization techniques and IRB approval.      

 
9 a.m. – noon
Groups Present and Defend Proposals
              


Noon
Lunch boxes to go

Schedule as of Feb. 6; subject to change.