Ecog-Acrin Medical Research Foundation Inc

ECOG-ACRIN NCORP RESEARCH BASE

ECOG-ACRIN OPERATIONS CENTER

ECOG-ACRIN BIOREPOSITORIES TO SUPPORT NCTN

REAL-WORLD DATA TO GENERATE REAL-WORLD EVIDENCE IN REGULATORY DECISION-MAKING - PROJECT SUMMARY THE RATIONALE FOR A MORE DETAILED UNDERSTANDING OF THE SAFETY AND EFFICACY OF NEW THERAPIES FOR CANCER IS COMPELLING. WHILE CANCER THERAPIES HAVE ALWAYS HAD AN ELEMENT OF RISK TO BOTH WELL-BEING AND TO QUALITY OF LIFE, MUCH HAS CHANGED IN THERAPEUTICS IN THE PAST TEN YEARS. MOST IMPORTANT, A GREATER UNDERSTANDING OF THE BIOLOGICAL CHARACTERISTICS OF CANCER HAS LED TO MORE NUANCED DEFINITIONS OF POPULATIONS THAT MAY BENEFIT THAN WERE PREVIOUSLY POSSIBLE. WITH GREATER USE OF GENOMICS AND RESULTING SPECIFICATION OF PRECISE MOLECULAR CHARACTERISTICS OF TARGET CANCERS, AND THROUGH (THOUGH EARLY) MARKERS OF SENSITIVITY AND RESISTANCE TO IMMUNOTHERAPEUTICS, BOTH THE INDICATIONS AND THE USE OF NOVEL THERAPEUTICS IS RESULTING IN HIGHER RESPONSE RATES AND MORE FAVORABLE OUTCOMES, AT LEAST AS JUDGED BY PROGRESS IN CLINICAL TRIALS. PARALLEL ADVANCES IN MEDICAL CARE AND THE UNIVERSAL ADOPTION OF AN ELECTRONIC HEALTH RECORD (EHR), COUPLED WITH ADVANCES IN QUALITY OF LIFE (QOL) AND OTHER PATIENT-REPORTED OUTCOMES (PROS), HAVE MADE POSSIBLE A DEEPER ANALYSIS OF THE EFFECTS AND THE RISKS OF NEW THERAPIES AS THEIR USE IS DIFFUSED THROUGHOUT THE MEDICAL SYSTEM. FOLLOWING UPON SEVERAL GUIDANCES TO THE EFFECT OF ENCOURAGING AND DEFINING THE USE OF REAL-WORLD DATA (RWD) TO PROVIDE REAL- WORLD EVIDENCE (RWE), THIS FUNDING MECHANISM IS DESIGNED TO FOSTER APPROACHES TO CAPTURE, ORGANIZE, AND ANALYZE RWD TO PRODUCE RWE. WE PROPOSE HEREIN A MANY-PRONGED APPROACH THAT BRINGS TOGETHER TWO STRATEGIES: 1) A REIMAGINING OF HOW ACQUISITION OF ROBUST, REPRESENTATIVE, AND ACCURATE RWD COULD BE OBTAINED FROM EXISTING CLINICAL TRIALS' PROCESSES; 2) HOW AN EFFECTIVE RWD APPROACH COULD GENERATE ROBUST RWE IN RARE AND LESS COMMON TUMORS ALIKE. TO ASSIST IN THIS GOAL, WE HAVE DEVELOPED A COLLABORATION WITH OPTUM LIFE SCIENCES, BOTH TO HELP RECRUIT DIVERSE POPULATIONS WITH SPECIFIC MOLECULAR PROFILES, AND TO CHARACTERIZE POPULATIONS WITH EXTENDED DATABASES IN VARIOUS DOMAINS. OUR AIMS ARE FIRST, TO HARMONIZE PHASE III AND PHASE IV EVALUATIONS OF NEW THERAPIES TO OBTAIN REAL-WORLD EVIDENCE OF THE STANDARD THERAPY IN PHASE III, AND SUBSEQUENTLY OF THE SUCCESSFUL THERAPY IN PHASE IV; SECOND, USING THIS COOPERATIVE GROUP MODEL, TO ESTABLISH FEASIBILITY OF A REAL-WORLD DATA PHASE IV APPROACH TO THE EVALUATION OF NEW THERAPIES FOR RARE TUMORS. WE EXPECT THAT BY DEVELOPING THESE APPROACHES TO RIGOROUS DATA COLLECTION IN A SHORT TIMEFRAME, WE WILL BE COMPLEMENTARY TO INFORMATICS APPROACHES TO DATA COLLECTION DEVELOPED IN PARALLEL AND PROVIDE FOR THEM A ROBUST DATABASE FOR COMPARATIVE ANALYSES.

TAILORX RXPONDER CLINICAL RESEARCH EXTENSION AWARD: ADVANCING PROGRESS PRECISION AND EQUITY IN BREAST CANCER CARE CUSTOMER

ECOG-ACRIN-BASED QIN RESOURCE FOR ADVANCING QUANTITATIVE CANCER IMAGING IN CLINICAL TRIALS

THE ECOG-ACRIN SUPPORT TRIAL: MULTILEVEL INTERVENTION TO IMPROVE DIVERSE ENROLLMENT IN CANCER CLINICAL TRIALS - ABSTRACT INADEQUATE DIVERSITY IN CLINICAL TRIALS IS WIDELY RECOGNIZED AS A SIGNIFICANT CONTRIBUTING FACTOR TO HEALTH DISPARITIES EXPERIENCED BY RACIAL/ETHNIC MINORITIES AND OTHER DIVERSE POPULATIONS IN THE US. THIS LACK OF PARITY CALLS FOR URGENT INITIATIVES AIMED AT INCREASING DIVERSITY IN ORDER TO SUPPORT MORE EQUITABLE REPRESENTATION IN CLINICAL RESEARCH AND BRING THE BENEFITS OF ADVANCES IN HEALTHCARE FORGED BY CLINICAL RESEARCH EQUITABLY TO ALL. NATIONAL CANCER INSTITUTE (NCI) SUPPORTED CLINICAL TRIALS (CTS) ARE KEY DRIVERS OF INNOVATIONS IN CANCER CARE; HOWEVER RACIAL/ETHNIC MINORITIES, AND BLACK AND LATINO POPULATIONS IN PARTICULAR, ARE UNDERREPRESENTED IN NCI-SUPPORTED CTS AND THUS NOT ABLE TO FULLY BENEFIT FROM CUTTING EDGE TREATMENTS AND PRECISION MEDICINE. CT PARTICIPATION AMONG BLACK AND LATINO POPULATIONS CONTINUES TO FALL SHORT AND THE MULTITUDE OF STRUCTURAL, CLINICAL, PHYSICIAN, AND PATIENT BARRIERS WARRANT MULTILEVEL INTERVENTIONS TO ENHANCE REFERRAL AND ENROLLMENT OF BLACK AND LATINO PATIENTS TO NCI-SUPPORTED CTS. THE ECOG-ACRIN CANCER RESEARCH GROUP (EA), AS AN NCORP RESEARCH BASE, HAS ENGAGED COMMUNITY PROVIDERS AND RESEARCHERS THROUGH A ROBUST RESEARCH PORTFOLIO THAT SPANS CANCER CONTROL, CANCER PREVENTION, AND CANCER CARE DELIVERY. WE PROPOSE TO LEVERAGE THE COLLECTIVE RESOURCES OF THE EA, OUR TEAM’S DECADES OF WORK ON IMPROVING DIVERSITY IN CLINICAL TRIALS, AND OUR FOUNDATIONAL WORK IN PATIENT NAVIGATION AND CT RESEARCH LITERACY TOOLS TO CREATE AND EVALUATE AN ECOG-ACRIN TRIAL SUPPORT TOOLKIT (SUPPORT INTERVENTION) THAT AIMS TO IMPROVE BLACK AND LATINO REFERRAL AND ENROLLMENT IN ACTIVE NCI-SUPPORTED THERAPEUTIC TRIALS IN HEAD AND NECK, THORACIC, AND GENITOURINARY CANCERS, AND LEUKEMIA AND MYELOMA. THE MULTILEVEL EA SUPPORT INTERVENTION CONSISTS OF A CT RESEARCH LITERACY TOOL AND CT RESOURCE NAVIGATORS BASED AT EA WHO WILL INTERFACE WITH PATIENTS, PROVIDERS, AND COMMUNITY ONCOLOGY SITE STAFF TO IMPROVE REFERRAL AND ENROLLMENT OF BLACK AND LATINO PATIENTS TO CTS. OUR SPECIFIC AIMS ARE TO: 1) CONDUCT PRELIMINARY ASSESSMENTS AND REFINE THE EA SUPPORT INTERVENTION WITH FOCUS ON COMMUNITY REPRESENTATION AND INPUT. 2) CONDUCT A HYBRID TYPE 1 CLUSTER-RANDOMIZED, ROLL-OUT EFFECTIVENESS-IMPLEMENTATION TRIAL IN 10 NCORP COMMUNITY ONCOLOGY PRACTICE SITES (WITH N= 500 BLACK AND LATINO PATIENTS WITH CANCER) TO EVALUATE THE EFFECTIVENESS OF THE EA SUPPORT INTERVENTION IN IMPROVING BLACK AND LATINO PATIENT REFERRAL AND ENROLLMENT TO NCI-SUPPORTED CTS (PRIMARY OUTCOMES) AND PARTICIPANT AND PROVIDER AWARENESS AND KNOWLEDGE OF CTS (SECONDARY OUTCOMES) WHILE ASSESSING IMPLEMENTATION FACTORS. 3) WITH THE CUSP2CT DATA, EVALUATION, AND COORDINATING CENTER, CONDUCT FINAL SITE EVALUATION AND DISSEMINATE THE SUPPORT INTERVENTION TO NCORP COMMUNITY ONCOLOGY SITES, RESEARCH BASES, AND AFFILIATED TRIAL NETWORKS. OUR COLLABORATIVE INFRASTRUCTURE AND EA SUPPORT MULTILEVEL INTERVENTION WILL SHIFT THE CURRENT CLINICAL TRIAL RESEARCH BASE REFERRAL AND ENROLLMENT PARADIGM AND DIRECTLY REMOVE MULTIPLE LEVELS OF BARRIERS THROUGH INNOVATIONS IN CT NAVIGATION AND CT RESEARCH LITERACY TOOLS.