Developing a Clinical Research Program (What it Takes) - American ...
Developing a Clinical Research Program (What it Takes) - American ...
Developing a Clinical Research Program (What it Takes) - American ...
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Building A <strong>Clinical</strong> <strong>Research</strong> Un<strong>it</strong>:<br />
<strong>What</strong> Does It Take<br />
John D. Puskas MD and Kim T. Baio MSN<br />
Emory Univers<strong>it</strong>y<br />
Atlanta, USA<br />
AATS/NIH Grant Wr<strong>it</strong>ing Workshop<br />
March 6, 2009<br />
Bethesda, MD
Disclosure Slide<br />
• Dr Puskas is a consultant to Medtronic and Maquet.<br />
• Medtronic and Maquet sponsor research w<strong>it</strong>hin the<br />
Emory Division of Cardiothoracic Surgery.<br />
• Dr Puskas served as International PI of the Cardica<br />
PAS-Port FDA trial, but has no financial relationship<br />
w<strong>it</strong>h Cardica whatsoever.<br />
• Dr Puskas serves as International PI of the ON-X<br />
valve PROACT FDA trial, but has no financial<br />
relationship w<strong>it</strong>h MCRI whatsoever.
<strong>What</strong> It <strong>Takes</strong>:<br />
1) Comm<strong>it</strong>ment of attending surgeon leaders<br />
and Director:<br />
• Active personal involvement; available<br />
2) $$$ from multiple sources<br />
3) Dedicated staff, FTEs not shared/part time<br />
4) Perseverance/sense of humor/joy in work<br />
5) Share success/cred<strong>it</strong> (co-authorship)/CRU<br />
serves our entire Division of CT Surgery
Sources of $$$<br />
(Temporal Order)<br />
1) <strong>Clinical</strong> revenues of our CT Division<br />
2) Industry<br />
3) Inst<strong>it</strong>utional/hosp<strong>it</strong>al funding<br />
4) Intramural grants: Coulter, EHC<br />
5) Extramural grants: AHA, NIH
Date Staff FTEs $$$ Source of $$$<br />
1996 1 CRC/database<br />
1 surgeon (part time)<br />
1 $70k clinical<br />
2003 1 CRC<br />
1 surgeon<br />
1 database<br />
2004 1 CRC<br />
1 surgeon<br />
1 database<br />
1 biostatistician (20%)<br />
2005 1 CRU Director<br />
2 CRCs<br />
1 surgeon<br />
2 database<br />
1 biostatistician (40%)<br />
2008 1 CRU Director<br />
4 CRCs<br />
2 surgeons; 5 PIs<br />
4 database<br />
1 biostatistician (80%)<br />
1 research fellow<br />
2 $140k clinical<br />
admin<br />
industry<br />
2.2 $155k clinical<br />
admin<br />
industry<br />
5.4 $350k clinical<br />
admin/hosp<br />
industry<br />
grants<br />
10.8 $750k <strong>Clinical</strong><br />
Admin/hosp<br />
Industry<br />
Grants (UO1)
<strong>Clinical</strong> <strong>Research</strong> Un<strong>it</strong> – Cardiothoracic Surgery<br />
February 2009<br />
Medical Director CRU<br />
John Puskas, MD, MSc<br />
Associate Director<br />
Vinod Thourani, MD<br />
Director, <strong>Research</strong> & Education<br />
Kim Baio, MSN, RN<br />
(ECLH)<br />
Data Manager<br />
Debbie Canup<br />
(ECLH)<br />
Biostatistician<br />
Pat Kilgo, MS<br />
(RSPH)<br />
CRN II<br />
Jayne Thompson, BSN<br />
(TEC)<br />
Alexis Neill, MSN<br />
(ECLH)<br />
CRC II<br />
Ellen Lyons, RT<br />
(TEC)<br />
CRC II-regulatory<br />
CRC II- Aortic Center<br />
POSTED<br />
CRN III<br />
Shannon Sm<strong>it</strong>h, BSN<br />
(ECLH)<br />
Thoracic Data<br />
Coordinator<br />
Peggy Jo Boyles<br />
(TEC)<br />
Adult Cardiac Data<br />
Coordinators<br />
Jean Walker (ECLH)<br />
Susan Joyce (EUH)
2011<br />
• Director<br />
• 8 CRCs<br />
• 2 surgeons; 8 PIs<br />
• 4 database<br />
• 1 biostatistician (1.0)<br />
• 2 research fellows (MDs)
Stumbling Blocks:<br />
1) Regulatory/Inst<strong>it</strong>utional processes and<br />
requirements. OSP/IRB/CTO are dysfunctional<br />
silos that do not communicate well w<strong>it</strong>h us or w<strong>it</strong>h<br />
each other<br />
2) <strong>Clinical</strong> demands on PIs lim<strong>it</strong> their time and focus<br />
for research<br />
3) Geographical separation of s<strong>it</strong>es/hosp<strong>it</strong>als<br />
4) Recru<strong>it</strong>ment of best talent<br />
5) Uncertainty of long<strong>it</strong>udinal support<br />
• “sell” value to the inst<strong>it</strong>ution<br />
• Renew grants!
How We Could Fail<br />
• Regulatory Infractions<br />
• COI<br />
• Lose Inst<strong>it</strong>utional support (pol<strong>it</strong>ics; value)<br />
• Fail to renew grants
2012 And Beyond<br />
• Add Cardiology and provide CRU services<br />
to the entire Emory Heart and Vascular<br />
Center<br />
• Increased role in QI/patient safety<br />
• Increase role in marketing<br />
• Expand biostatistical capabil<strong>it</strong>y<br />
• Expand to become a CRO for hire<br />
(InChoir; NERI; DCRI)
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