AATS Clinical Trials Methods Course

Preliminary Program*
Day 1 | Thursday, October 25, 2018

12:00 PM

Registration Opens

1:00 PM

Introduction and Welcome
David H. Harpole, Jr. & Marco A. Zenati

1:15 PM

Leadership Role of Cardiothoracic Surgeons in Clinical Trials
Faisal G. Bakaeen

1:35 PM

Selecting the Clinical Question for Your Trial
Annetine Geljins

1:55 PM

How to Design a Randomized Trial
Joe Massaro

2:15 PM

Challenges at the Conception Stage of a Randomized Trial
Emilia Bagiella

3:35 PM

Discussion

4:00 PM

Coffee Break

4:30 PM

Introduction to Breakout Groups
David H. Harpole, Jr. & Marco A. Zenati

4:45 PM

Group Breakouts

6:45 PM

Break for Dinner

8:30 PM

Dealing with the FDA
John Sapirstein

Day 2 | Friday, October 26, 2018

7:00 AM

Continental Breakfast

7:30 AM

Overview of Day 1 and Introduction to Day 2
David H. Harpole, Jr. & Marco A. Zenati

8:00 AM

Choice of Primary Outcome Measure/Sample Size Calculations
Emilia Bagiella & Joe Massaro

9:00 AM

Special Consideration in Designing Trials Under FDA Rules
John Sapirstein

9:20 AM

What I Wish I Had Known Earlier in RCTs
Faisal G. Bakaeen

9:35 AM

Coffee Break

10:00 AM

Morning Breakout Groups

12:00 PM

Lunch

1:00 PM

Multicenter Trial Organization and Implementation
Jennifer Gabany & Marco A. Zenati

1:20 PM

Budget and Funding Options for Randomized Trials
David H. Harpole, Jr. & Mary Beth Joshi

1:40 PM

Clinical Trials in the NIH/NHLBI CTSN
Annetine Geljins

2:10 PM

Coffee Break

2:30 PM

Afternoon Breakout Groups

5:00 PM

Proposal Presentations

6:00 PM

Break for Dinner

7:30 PM

Meeting of Study Sections

Day 3 | Saturday, October 27, 2018

7:00 AM

Continental Breakfast

7:30 AM

Overview of Day 2 and Introduction to Day 3
David H. Harpole, Jr. & Marco A. Zenati

7:45 AM

Study Sections Reviews

9:00 AM

Lessons from the NIH/NHLBI CTSN Network
Annetine Geljins

9:15 AM

Coffee Break

9:45 AM

Ethics of Clinical Trials
David H. Harpole, Jr.

10:00 AM

CONSORT Criteria, Publishing Your Results
Marco A. Zenati

10:15 AM

Discussion

10:30 AM

Closing Remarks: Attendee Feedback & Recommendations for Future Courses
David H. Harpole, Jr. & Marco A. Zenati

11:00 AM

Adjournment



*Program subject to change.