1. How to Build A Successful Clinical Research Program
David A. Cox, MD FSCAI FACC
Lehigh Valley Health Network
Director, Interventional Cardiology Research
Co-Director, Cardiovascular Research Institute
Associate Director of Cardiac Catheterization Laboratory
Allentown, PA
CRT 2013

2. David A. Cox, MD Consulting: Legal Review Honoraria: Abbott Vascular
Boston Scientific Corporation
Medtronic
theMedicinesCompany

3. Reality and ‘real world practice’ are often turned upside down by good clinical trials….

4. Focus Clinical research: a new world Getting studies still key
High Enrollment
High Quality
Costs Down
Research is a team…we need to get coordinators and investigators on same page
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5. What are we up against?
Since 2002, FDA–regulated investigators based outside the United States has grown by 15% , whereas the number of US-based investigators has declined by 5.5%
Of 300 clinical trials published in NEJM, JAMA, & Lancet between 1995 – 2005 reviewed, the number of trial sites outside the US more than doubled over the 10 yrs, whereas proportion of trials in US decreased
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Glickman S, et al. NEJM. 2008;360: 6

6. Increasing Protocol Complexity
>10,000 phase 1-4 protocols conducted between 1999 – 2005.
US-based investigators
Work burden per protocol – “Annual” Growth Rate between 1999 and 2005 of 10.5%
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CRF
Getz K, et al. Am J Therapeutics. 2008; 7

7. Cardiology Practice % Private Practice Group – 100 Cardiologists
Dedicated Research Department with Chief Administrator and 9 FTE’s
Percent Reduction in Number of Patients Enrolled in PCI Clinical Trial Studies Compared to Baseline 2006 %
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2007
2009 8

8. Regulatory Burdens: The IRB
Presenting to the IRB
Informed consent documents already FDA approved are changed with complex legal language rather than straightforwardly detailing a study’s rationale and potential risks and benefits.
Are patients or the institution being protected?
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Califf R. JAMA. 2009; 302:2025. 9

9. The major problem with doing clinical research….

10. When Protocols aren’t followed…..

11. It takes a team!

12. Research Coordinators
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13. Understand Your Coordinators
No Energy Left.
Alternative Use of Time
Plus
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14. Nurses: Keystone of Clinical Research
Identify and hire nurses interested in clinical research
Experience can be taught…enthusiasm can’t .
Visit a site doing research in a setting similar to yours…do it again and compare notes later.
A intelligent, patient-oriented research nurse who takes ownership of protocols and good research practices is key

15. Growing the Research Nurses
Goal: Make involvement in research what every nurse wants
Great hours, nice investigator meetings, pride in enrollment status
Create an environment where research coordinators are empowered and involved.
Turn-over is going to happen, so growing the culture to attract others is important.

16. Give the correct support….

17. Provide the Infrastructure for Success18 18

18. Get to Starting Line Early
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20. Get to Starting Line Early Clear the IRB Sign the Contracts
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21. Even with proper support……

23. Naïve co-PI?

24. Ranting and Raving This is the Bulleted List slide.
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27. Protocols: So Many Choices

28. Not all Shoes Fit

29. Not all Shoes Fit
Some protocols lend themselves to enrollment---easy randomization, familiar devices/drugs
Some co-PI’s best not involved with complex devices
Success in research is more dependent upon enthusiasm and drive of site PI than how many co-PI’s participate
We need to do a better job listening to our research nurses when enrollment is poor

30. Industry supported research
RCT’s lead to large follow-up registries….GET INVOLVED!
If chosen for RCT…
Clean data..consistent charting
Strict I/E approach
Rigid follow-up
Rapidly report adverse events
SEPARATE trial involvement from marketing

31. Not all shoes fit II
Know the strengths of your site—if you aren’t a big primary PCI center, don’t do primary PCI protocols. Ditto DES with angio follow-up.
The protocol has to fit your site’s interest and practice patterns or otherwise you are wasting your time..AND YOU MUST FOLLOW IT !!!!!!!!!

32. Some Protocols work for your site….others don’t!!!

33. Know Your Site: Know What Kind of Study You Can Deliver Results
Stent Trial
STEMI
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35. Financial Barriers
Clinical Research Sites are Struggling with Finances
Fewer research projects
Off Shoring
Contemporary Financial Environment
Fixed or increasing overhead
Failure to appropriately prioritize research, wasting resources on relatively low-quality projects
Sinking Ship
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36. Financial Barriers Profit Center Cost Center
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37. Money Matters This is the Bulleted List slide.
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38. Revenue Costs Well Funded Studies Minimum Turnover Few Loss Leaders
5 Star Enrollment
Negotiate !!!!!!
Minimum Turnover
20% do 80% of the Work
Hire Carefully
Good Administrator
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Revenue
Costs 39

39. Solutions: An Opportunity
Integrated Cardiology-Hospital Systems
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40. Solutions
Clinical research: A mission at your health care system? In not, in this day and age, keeping your head above water in clinical research is tough! Fewer protocols, less staff?
If research is viewed at odds with providing efficient health care in your system, you probably are wasting your time.
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41. Solutions
If health care systems are unwilling to create a culture to facilitate research participation, the current decline in research participation by coordinators and physicians will continue or accelerate.
Physician investigators and their institutions need to establish clear processes for reviewing and assigning priority to research projects to avoid wasting resources on poorly designed investigations.
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43. Patient Advocates: Primary Role
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