Citeline患者参与和招聘解决方案

Identifying Successful Recruitment Strategies forDifferent Protocols/Indications/Therapeutic Areas C I T E L I N E . C O M Matt HolmsVP, Patient Engagement &Recruitment Clinical Research Enrollment Landscape Challenges Complexity Increasing •35% increase in average trialduration•80% of trials are delayed dueto recruitment challenges*•~85% of trials need >1amendment Determine Best Patient Recruitment Strategy for Your Protocol The following play a key role defining a fit-for-purpose patient recruitment strategy: ▪Therapeutic area/indications: common/chronic disease vs. rare/complex diagnosis ▪Acute diagnosis/narrow windows for a treatment plan▪Complex labs, gene mutations, biomarkers and/or procedures are key protocol I/E criteria▪Study phase & enrollment accrual targets▪Managing site burden & enrollment optimization support services Fit-for-purpose Approach to Recruitment Solutions Comprehensive, modularand aligned to specifictherapeuticareas/indications Citeline’s GlobalMarketplace of100+pre-contracted/pre-vettedvendors operating in a pay-per-performance model under one MSA Due Diligence & Contracting in PlaceRecruitment partners are alreadyprecontracted, pre-vetted and haveMSAs in placethrough Citeline forsimultaneous activation on studies Marketplace ModelAn industry-first patient recruitment network (“one-to-many”or “crowd-sourced” effect) Risk-share BudgetSponsors areonly invoiced uponperformance(i.e., patient deliverymilestone) Reach Untapped PatientsDiverse communities drive engagement throughmultiple channels; email, socialmedia, advertising Analytics: Campaign, Sites & Diversity Performance Metrics Harness real-time, comprehensive data streams to ensure no detail is missed. Our robust tracking tools offerunparalleled visibility into every facet of patient outreach and trial engagement. Study and portfolio-level analytics for Citeline orsponsor-owned campaigns integrated in one place Demographic breakdown of anonymized referrals totrack against study-specific diversity goals Site performance including responsiveness tonewreferralsand automating site existing efforts Direct-to-Patient Strategies for Patient Recruitment Best aligned for: ▪More common, chronic indications (i.e., obesity)▪Less complex protocol I/E criteria▪When “self-reportable” prescreener questions CAN covermost of protocol’s I/E criteria→more “qualified” referral Not well aligned for: ▪Complex/rare/acute indications (i.e., oncology/rare disease)▪More complex protocol I/E criteria (i.e., labs, biomarkers)▪When “self-reportable” prescreener questions DO NOTcover majority of the protocol’s I/E criteria What recruitment strategies make sense for more complexstudies with the following attributes? ▪Complex I/E criteria and/or diagnosis detected with difficulty▪Complex labs, gene mutations, biomarkers or procedures that arekey to a protocol’s I/E criteria▪Acutely diagnosed with narrow window to get on a treatment plan▪Oncology, rare disease or ANY Indication with above components Citeline PatientMatchis designed for these more complex studies byleveraging Citeline’s unparalleled data asset and tokenized/deidentified data. CombineRWDwithCiteline proprietary data assetsasthe foundation behindCiteline Patient Match Citeline’s PatientMatch Offering Overview Examples of CitelineEMR Data–Structured vs. Unstructured Example ofunstructurednote: Example ofstructureddata: Note:Structured data contains mostly lab examinations&claimsdata, sourced in tables. Note:Unstructured data contains mostly EMR, physician notes, site &investigator data, sourced as free text. **NoteDe-Identified viaObfuscation**RADIATIONONCOLOGY PROSTATEFOLLOW-UPVISITNOTEDATEOFSERVICE:3/14/2023REFERRINGPRACTITIONER:NorrieBlinks,MDPRIMARYCAREPROVIDER:CarinGlen,NikitaMeth.,MD RESIDENTPHYSICIAN:ClaraCaulk,PA ATTENDINGPHYSICIAN:AnaghaNailsMax,PACHIEFCOMPLAINT:3monthfollow-upsinceCOT,7monthssinceCOTIDENTIFYINGDATA/ONCOLOGICHISTORY:isa68y.o.malewithrecentlydiagnosedmetastatichigh-riskprostatecancer(byPSMAPET/CT)diagnosedafterptunderwentTURBT(iPSA18.4,bGS5+4=9,gradegroup5,cT1c,iT4).MRprostate7/22/22revealedalargePI-RADS5bilateralentireprostatelesionwithbothanteriorand posterior components that has gross extracapsular extension with definiteneurovascularbundleinvolvement,seminalvesicleinvasion,invasionintothebladderneckandinfiltrationoftheDenonvilliersfasciawithabutmentoftheanteriorrectalwall.PSMAPET/CT7/26/2022revealedPSMA-avidityinthepelvicLN(leftcommoniliac,bilateralexternaliliac,leftinternaliliac,presacralnodes)andaT9vertebralbodylesion.Baselineprostatevolume36g,IPSS13.He underwent SRS 20 Gy to the T9 vertebral body on8/18/2022.STAGE:CancerStaging Prostatecancer(HCC/RAF)Stagingform:Prostate,AJCC8thEdition-Pathologicstagefrom7/25/2022:StageIIIC(pT4,pN0,cM0,PSA:18.4,GradeGroup:5)-UnsignedRADIATIONHISTORY:8/18/2022:SRS20Gy/1fxtotheT9vertebralbodyDATAOF INTERVAL HISTORY:Prostate-FU Data Fields~Data~CommentsMostrecentPSAlevel~<0.01~RecentPSAdate(m/d/yy