The Clinical Trials Methods Course will provide an intensive and interactive training program for cardiothoracic surgeons across all subspecialties (adult and pediatric cardiac, general thoracic) to acquire the critical skills required in effective clinical trial design and implementation. This course is particularly suited to help professionals who are considering applying for clinical trial funding to better understand the complex nature of preparing and submitting clinical trial proposals. Invited faculty will include currently funded clinical trial leading investigators and leaders in the field of biostatistics and health sciences research. The program will offer a process in which the clinical trial protocol development can be streamlined. Hands-on focus groups and mock study sessions will be conducted. Preparatory materials will be provided to each registered attendee and they will be required to come to the program prepared to develop their own clinical trial idea.
Program topics include:
- Selecting the Clinical Question for your Trial
- How to Design a Randomized Trial
- Challenges in the Conception Stage of a Randomized Trials
- Dealing with the FDA
- Choice of Primary Outcome Measure/ Sample Size Calculations
- Special Consideration in Designing Trials Under FDA Rules
- Lessons Learned in the "ROOBY" Trial
- Multicenter Trial Organization and Implementation
- Budget and Funding Options for Randomized Trials
- Randomized Clinical Trials in the Age of Machine Learning and Artificial Intelligence
- Point-of-Care Randomization Trials
- Lesson learned from the PIs of the REGROUP, ROMA, and VALOR trials
David H. Harpole, Jr.
Marco A. Zenati