This application contains a proposal to be awarded a Clinical Research Skills Development program and to be selected as a Core Clinical Center (CCC) for the Cardiothoracic Surgical Trials Network (CTSN). We describe our experience as one of the two Clinical Research Skills Development programs funded at the initiation of the CTSN and outline our proposed innovations to improve recruitment of trainees who have outstanding potential to become leaders in academic thoracic surgery in the field of clinical research. We also describe the proposed educational environment, mentorship, and access to support in completing a clinical research project to achieve a Master's level degree in clinical research. We also propose to be a high-performing CCC through superior recruitment and retention of cardiac surgical patients for clinical trials developed by the Network;we can achieve this by working together with other sites and the Data Coordinating Center to promote effective trial design and analysis and by contributing innovative ideas to improve the ability of the Network to accomplish its goals. In this application, we describe our performance as a CCC in the first five years of its existence and our general performance in site-based clinical research i cardiac surgery patients during the same time period. We also critically evaluate three """"""""Mock Trials"""""""" provided in the RFA as a vehicle to demonstrate our understanding of the issues that affect successful completion of clinical trials and to propose innovations to overcome obstacles and promote that success.

Public Health Relevance

It is critically important to advance the field of Cardiothoracic Surgery by using clinical research to identify and confirm the effectiveness of new surgical approaches and new technology. Of equal importance is to develop clinical research skills (Master's Level) in promising current and future Cardiothoracic Surgeons to lead the advancement effort.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
2UM1HL088953-06
Application #
8488632
Study Section
Special Emphasis Panel (ZHL1-CSR-H (F1))
Program Officer
Miller, Marissa A
Project Start
2007-07-01
Project End
2018-01-31
Budget Start
2013-07-15
Budget End
2014-01-31
Support Year
6
Fiscal Year
2013
Total Cost
$412,495
Indirect Cost
$177,421
Name
Duke University
Department
Surgery
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
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