Disclosures Advisory Board: Abbott Vascular Boston Medical

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

“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”

How can we improve enrollment in clinical trials?

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

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

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!

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’

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

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

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”

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”

PI’s can get grumpy

Sub I’s are not easy

Research Coordinators in Tough Place

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

Not all shoes fit

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!

Lots of Trials to Choose From

Lots of Trials to Choose From: Focus on YOUR Site

Not all Docs are good enrollers in clinical trials

Make Sure You Can Deliver

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

Research Coordinators: Key to Success

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.

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

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

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

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

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

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

“When I get back home!”