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Clinical Trials Subject Recruitment:Ongoing Challenges and a Powerful New ToolOctober 27, 2010Dan Kolk, RNDirector, Office of Clinical TrialsClinical Research Infrastructure System (CRIS)UW Institute for Clinical and Translational Research (ICTR)


The Problem of Research ParticipantRecruitmentGROUP 1WILLING RESEARCHVOLUNTEERS ARE LOOKING FORSTUDIESGROUP 2RESEARCHERS ARELOOKING FOR STUDYVOLUNTEERS


ResearchMatch !!– A web-based recruitment registry developed to matchvolunteers willing to participate in clinical trials withresearchers looking for participants for an approvedstudy– Funded by <strong>the</strong> Clinical & Translational ScienceAwards (CTSA) NIH/NCRR2006– Registry tool overseen by <strong>the</strong> Vanderbilt IRB– Available to investigators at all CTSA sites throughout<strong>the</strong> country-54 CTSAs are part of <strong>the</strong> ResearchMatchNetwork


What ResearchMatch is…. A new ‘matching’ tool to help volunteers easilyconnect with research studies An innovative national partnership to develop acentralized web-based recruitment registry A free, complementary recruitment tool Secure & promotes volunteer choice at all levels Disease-neutral Anyone residing in <strong>the</strong> US can join


What ResearchMatch is not…• The end-all solution to participant recruitment• A replacement for successful, existingrecruitment efforts• A tool that permits ‘cold calling’ volunteers• A singular mechanism for finding patients fordisease-specific investigations• A subject or data management tool for a specificstudy


How does ResearchMatch work?1) Potential subjects nationwide voluntarily sign up via asecure website which allows password access to <strong>the</strong>iraccount2) Investigators register <strong>the</strong>mselves and <strong>the</strong>n <strong>the</strong>ir IRBapprovedstudies on <strong>the</strong> same website utilizing“researcher” access3) ResearchMatch, by way of local institutional liaisons,connect <strong>the</strong> volunteer to <strong>the</strong> research; firstanonymously, <strong>the</strong>n directly with <strong>the</strong> volunteer’spermission.4) Recruitment <strong>the</strong>n follows local IRB-approvedmethodologies


Key Component #2 : ResearchersWho can use ResearchMatch for study Recruitment?• You must hold a UW faculty appointment or be amember of <strong>the</strong> study staff of a faculty member toregister as a ResearchMatch investigator.• A study coordinator or o<strong>the</strong>r study staff can beauthorized by <strong>the</strong> registered study PI to recruitthrough ResearchMatch;• ResearchMatch will allow multiple users toregister for <strong>the</strong> same study


Types of Researcher Access• Feasibility Access– Allows viewing of aggregate blinded data– Specific criteria entered to determine if RM population may beuseful recruitment source for specific data– May be used prior to IRB approval of study• Recruitment Access– Provides ability to indirectly reach subjects who meet generalscreening criteria and offer <strong>the</strong>m opportunity to allow directcontact– Requires IRB approval and registration of study and <strong>the</strong> specifictext to be used in recruiting message to potential subjects


Key Component #3: Liaisons• Each participating site has at least 1 Institutional Liaison who isresponsible for managing researcher requests from <strong>the</strong>ir institutionthrough ResearchMatch• UW-Madison Liaison is Dan Kolk• Liaison approval consists of reviewing registered information &uploaded IRB approval letter from researcher• Liaison is responsible for setting ResearchMatch access expirationdate to match that of <strong>the</strong> IRB approval letter expiration date– Liaison Approval – automatically notifies researcher of recruitment accessprivileges• Liaison will be able to review recruitment messages sent byresearchers affiliated with institution• Individual and institutional metrics provided to Liaison through“Liaison Dashboard” to provide feedback regarding utilization


Scope of UW ResearchMatchInitiative• Initially, only studies approved through <strong>the</strong> HS-IRB, HS-Minimal Risk, and WIRB (under <strong>the</strong>oversight of <strong>the</strong> HS-IRB) will be allowed toparticipate and enter studies• WHY? Only <strong>the</strong> HS-IRB was involved indeveloping <strong>the</strong> original agreements and review.Once utilization and issues are addressed,ResearchMatch may be proposed to o<strong>the</strong>r UWbasedIRB’s


IRB approval of ResearchMatchrecruiting• HS-IRB acknowledges RM as an approvedrecruiting tool. Must be specifically listed in <strong>the</strong>recruitment methods– WIRB app: Recruitment section, q.38: check <strong>the</strong> box“…database for which subjects have given permissionto be contacted for research studies”– HS-IRB: SectionVII.C.12: Specifically listResearchMatch (no IRB approval #). Specificregistration of <strong>the</strong> study to ResearchMatch will onlyoccur after IRB approval.– In section C.11, detail <strong>the</strong> recruitment text and anyfliers that will be attached.


Getting Started• Go to :https://www.researchmatch.org/researchers/


Researcher Registration• Enter your contact information, create a unique username and password


ResearchMatch Recruitment Registration


ResearchMatch Recruitment Registration (cont.)• Enter study descriptivedata• Specify HS-IRB, MinimalRisk IRB, or WIRB• Upload electronic file ofmost recent approvalletter


Researcher RM Access page


Following <strong>the</strong> Registration request…• You will receive an automatic email that yourstudy is pending review.– You will be notified by email;– If your request is approved, you MUST accept thisaccess through <strong>the</strong> confirmation email.– If your request is denied, you can resubmit/edit youroriginal submission by accessing your denied studythrough <strong>the</strong> Researcher Dashboard.


Liaison Confirmation• You will receive this email response when <strong>the</strong> recruitmentregistration request has been approved:


Searching Process• Select <strong>the</strong> study you have already registered and search forpotential volunteers


Searching Process (cont).• Follow <strong>the</strong> steps of building <strong>the</strong> search criteria


Searching Process (cont.)• Select <strong>the</strong> volunteer profiles you wish to be contacted


Contacting Volunteers• Copy your IRB-approved text into <strong>the</strong> contact email which isprovided for you; DO NOT include any direct contact informationsuch as name, phone, or email


ResearchMatch Recruitment Email– ResearchMatch emails similar to study recruitmentfliers• Contacting Volunteers through ResearchMatch involvesdeveloping an electronic announcement or flyer forResearchMatch Volunteers to see and consider• Do not include any contact information for your study (emailor phone)– Volunteers that respond yes will release informationto be contacted directly– Start <strong>the</strong> consent/enrollment process


Contacting Volunteers• ResearchMatch will send <strong>the</strong> email to <strong>the</strong> potential volunteers thatyou have identified. The volunteer will respond yes, no, or noresponse to a request for direct contact.• The researcher will receive a listing of <strong>the</strong> “yes” responses for directcontact and recruitment


ResearchMatch Volunteer Recruitment Process• Wisconsin-based volunteer recruitment will be a key toresearcher value of <strong>the</strong> site• Many methods of making <strong>the</strong> public aware ofResearchMatch and encouraging registration will takeplace over <strong>the</strong> next four months• Current ResearchMatch national enrollment- 11,167• Wisconsin volunteer enrollment- 53


ResearchMatch Timelines• October 2010: General <strong>Presentation</strong>• November 2010: Subject Recruitment initiatives• January 2011: Researcher/ Study Team training sessions• February 2011: ResearchMatch webpage with tools and tips• Feb-March 2011: Study Registration- feasibility searches• March 2011 Study Recruitment can begin

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