1. Tips on How to Increase Screening and Enrollment into Clinical Trials
D. Chris Metzger, MD Wellmont CVA Heart & Vascular Institute Kingsort, TN, USA

2. Disclosures (D. Chris Metzger, MD)
Symposium Honoraria and Course Proctor
Abbott, TriVascular/ Endologix
Symposium Honoraria
Bard, Cardiovascular Research Foundation, Boston Scientific, CSI, Medtronic
National PI
CANOPY, SAPPHIRE WW, PREVEIL, CONFIRM, CONFIDENCE
Stock, Research Grants, etc- NONE
VIVA Board Member

3. Chris Metzger? Kingsport, TN??
“Who Dey??”

4. Chris Metzger; Kingsport, TN
#1 or 2 enrollers in 29 major Clinical Trials
ACT 1, SAPPHIRE WW, ABSORB 3, Levant 2, HORIZONS-AMI, CORAL, INPACT.SFA, SUPERB, etc.
6 FDA Audits
High patient follow up rates
3 NEJM, 2 Circulation, 3 JACC publications within the last year
And we have fun and get along well 

5. Absorb III Final Enrollment

7. LEVANT 2 DCB RCT

9. Research Basic Rules! (BEFORE we talk about “succeeding” w/ enrollment…)
“YOU MUST FOLLOW THE RULES DR.!”
Rules of research are unique
Following specific rules not natural to docs
Protocols are VERY specific, must follow
Poorly followed protocols/ enrollment hurt research, gives your site a bad reputation, & get you in trouble
ONLY enroll appropriate patients w/ ALL I/E met!
High enrollment does NOT = “good research”

10. So How Do You Maximize Enrollment at your Site??
Simply put, you implement strategies that maximize the percentage of eligible, motivated, and appropriate patients that are offered enrollment in your studies

11. Research is a “Team Sport”
While “individual champions” are needed, …
Must have research infrastructure in place
Experienced RC’s, IRB, Follow up, Regulatory, etc
You must have “buy in” from partners, cath lab, hospital, referring docs, research team
Must be able to smoothly have cooperative interdisciplinary collaboration

12. Start Slowly, Concentrate on Excellent Performance
Pick a study in your “wheelhouse”
Enroll well, have great follow up, “iron out the bugs”, learn the process..
Build a reputation
“Success begets success”

13. Pick the Right Study for YOUR Site
Areas where group is strong (CCL)
Start with less, carefully selected studies
Gain experience, do well with a few first
Avoid competing studies
Avoid predictably low-enrolling studies
Confirm interested PI before accepting
You want to develop a reputation for good enrollment and good performance

14. PI- Want an Enthusiastic Study Champion!
Involved, hands-on PI helps GREATLY!
Also need excited Lead RC (spur the PI)
PI/MD introduction of study and enthusiasm for it to pt’s will greatly help enrollment
PI should facilitate cooperation between departments- CONSISTENTLY positive
PI should market study to partners and medical community; get “buy in”

15. Find Other Interested Partners “Research Soulmates”
Micheal Dew, MD; Neurology
Rahul Sakhuja, MD: Endovascular,
Interventional, Structural; Friend

16. How to Find Study Patients?
Waiting for pt’s to come to you won’t work
Consider where patients in your study come from, and identify ways to meet them 
Educate/ advertise to sources of study patients: partners, ER, primary care providers, noninvasive imaging centers, patients
Should find a way to screen EVERY patient undergoing procedures involved in studies you are enrolling in (ESP. elective ones!)

17. Finding Patients- 2
Consider “staging” procedures in a way that allows appropriate enrollment-
Understand the protocol (e.g SFA trials)
Identify missed patients and modify approach based on lessons learned- monthly Research meetings
Educate, encourage, & rebuke partners

18. Make It Easy for Patients to Get into Studies
You must have a FRIENDLY “easy access” system for study patients identified
RC’s must help with all parts of patient enrollment (non- research docs main job is to identify & refer)
RC’s/ PI should make research participation as streamlined as possible for referring docs, staff involved, patients, and their families

19. Get Group Buy in and Share Success
We get “blanket” up front approval for ALL patients in our practice to be approached for research protocols
Individual MDs are NOT called for each patient
We inform group of studies before they start, and update them during the trial
We share the success of the trial with them

20. Cooperation with Other Departments is Key!
Research participation often involves multiple departments (ER, cath lab, labs, EKG’s, noninvasive studies, PCP’s, etc.)
Friendly cooperation is paramount
Know the “go-to” staff, befriend them!
Set up “lunch & learn” and buy the lunch
Provide them with a direct research contact number (and get theirs)

21. Research Patients
Treat them well! (or you won’t get their friends, their doc’s pt’s, & they won’t F/U)
Schedule study visit on same day as studies and needed office visits
Follow them in hospital, provide them w appt cards and #’s needed, be a resource and a friend

22. Other Ways To Improve Enrollment
Involve your CEO (get them excited)
Regular Research meetings- modify approach based on lessons learned
Incentivize RC’s appropriately (e.g. budget for bonus for PM call/ AMI for research pt’s)
Share success with partners
Advertise, encourage, and remind…

23. Example 1 Infuse AMI Trial
Needed: Anterior MI pt’s w/in 5 hrs of sx’s
Hurdles:
“Door to Balloon”- no time for RC to consent
Many MI’s at night
Wrong meds given in ER exclude patient
Solutions:
PCI docs consent pt’s in ER (DOA log)
Budget for RC’s to get paid; they randomize
ER/group meeting: all pt’s get 4000U heparin

24. CONCLUSIONS
Increasing enrollment comes from an enthusiastic, systematic approach which makes it enjoyable for all involved to enroll a maximum percentage of appropriate research patients

25. Thank You for Your Attention!