1. Disclosures
Advisory Board: Abbott Vascular Boston Medical

2. How to Be Persuasive to Enroll Patients into Clinical Trials
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 2012
Washington DC

3. “We screened lots of patients for this protocol but enrolled….three”
How to Enroll:
“We screened lots of patients for this protocol but enrolled….three”

4. How can we improve enrollment in clinical trials?

5. Step 1 UNDERSTAND AND KNOW THE PROTOCOL
Don’t waste time trying to enroll someone who doesn’t qualify

6. What my research nurses tell me about investigator’s brains
Clinical Med
Sex
Hunger
Survival
Understand
and follow clinical
research protocol 6

7. Step 2
Quit whining about how hard it is to do research in the United States
Agree that certain geographies and patients better lend themselves to enrollment
DEFINE WHAT WORKS AT YOUR SITE AND….JUST DO IT!

8. Why should we even do research?
RCT’s and real-world registries…pride of interventional cardiology
That said, we often hear about an ‘ongoing crisis in clinical research’

9. Ok, I accept its tough IRB issues a nightmare
Financial realities are not pretty
Good help is hard to find
Not all docs can do clinical research
Not all patients want to participate
Still…..we move the field forward by doing clinical trials

10. Step 3: Understand and Appreciate Your Research Staff
What’s the real crisis?

11. Research Nurse Concerns
“I’ve screened lots of patients for this protocol,….none seem to fit!”
“I’ve been scanning the labs to see if patients qualify…none do”
“Mrs. Jones qualifies, but I couldn’t get her to sign the consent”
“I asked Dr B to talk with Mr White about the protocol…he wouldn’t”

12. Research Doc Concerns
“Why are we screening so many patients but enrolling no one?”
“I really don’t have time to explain the protocol to anyone”
“Its not my job to get the protocol signed”
“I don’t really need to follow that part of the protocol”

13. PI’s can get grumpy

14. Sub I’s are not easy

15. Research Coordinators in Tough Place

16. How to enroll better in clinical trials
What I hear from nurses….
not getting enough help from the PI and sub-I’s.

17. Not all shoes fit

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

19. Lots of Trials to Choose From

20. Lots of Trials to Choose From: Focus on YOUR Site

21. Not all Docs are good enrollers in clinical trials

22. Make Sure You Can Deliver

23. 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 research nurses and PI than how many co-PI’s exist
We need to do a better job listening to our research nurses when enrollment is poor

24. Research Coordinators: Key to Success

25. Nurses: Keystone of Clinical Research
If you are happy with your enrollment performance…..keep research nurses fulfilled and happy!
If enrollment is lacking…..dialogue needed.

26. Nurses: Keystone of Clinical Research
Experience can be taught…enthusiasm can’t .
Visit a site doing research in a setting similar to yours.
Learning how to screen better and less painfully is key to enrollment

27. I’m not Dr Phil, but….
Research nurses and docs need to sit down and better define how to get patients screened for a specific protocol
It may take a focused intervention ie for the next 4-6 weeks, bug docs to help with screening and identifying patients
The ‘White Coat’ effect…docs should be involved in explaining protocol, research
Once it clicks, should be self-sustaining
We all can learn from each other

28. How to Enroll More! All patients are potential research candidates
7-8 AM—research nurses and doc meet at cath lab to identify possible patients to consent
Consenting by research nurses with MD back-up
Research nurses in lab with patient as cath done to help with protocol question
PI availability

29. Case Study: SAFE-PCI
Randomized trial RADIAL vs FEMORAL approach in Women
Docs that are biased one way…don’t ENROLL!
Staff in holding area explain that either approach is good and Doc will discuss
Physician, Nurses, NP’s,PA’s all avoid Bias in discussion

30. Case Study: SAFE-PCI
Cath doc meets patient and begins discussion of SAFE-PCI trial
Focus upon voluntary participation
Points out ease of follow-up..no blood draws etc
Research Nurses approach and consent and randomize
PI availability for any questions

31. We forgot how to listen to each other as a research team
How to enroll better???
What’s the real crisis?
We forgot how to listen to each other as a research team

32. “When I get back home!”