AATS Clinical Trials Methods Course

Final 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

Selecting the Clinical Question for Your Trial
Annetine C. Geljins

1:35 PM

How to Design a Randomized Trial
Joseph Massaro

1:55 PM

Challenges at the Conception Stage of a Randomized Trial
Emilia Bagiella

2:15 PM

Dealing with the FDA
John S. Sapirstein

2:35 PM

Discussion

2:45 PM

Coffee Break

3:15 PM

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

3:30 PM

Breakout Groups

5:30 PM

Day 1 Adjourns

 

 

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 & Joseph Massaro

9:00 AM

Special Consideration in Designing Trials Under FDA Rules
John S. Sapirstein

9:20 AM

Lessons I Learned in the "ROOBY" Trial
A. Laurie W. Shroyer

9:35 AM

Coffee Break

10:00 AM

Breakout Groups

12:00 PM

Lunch

1:00 PM

Multicenter Trial Organization and Implementation
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 C. Geljins

2:10 PM

Coffee Break

2:30 PM

Breakout Groups

5:00 PM

Proposal Presentations

6:00 PM

Break for Dinner

7:30 PM

9:00 PM

Meeting of Study Sections

Day 2 Adjourns

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 C. 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

AATS Clinical Trials Methods Course Adjourns