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

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

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

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 

Absorb III Final Enrollment

LEVANT 2 DCB RCT

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”

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

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

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”

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

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”

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

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!)

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

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

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

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)

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

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…

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

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

Thank You for Your Attention!