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.
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.
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
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.