Abstract B040: GRECO: A novel patient-centered research methodology to broaden participation in clinical research

Whilst advances in clinical research have been made rapidly in the field of oncology research, there remains significant unmet medical need in reaching traditionally under-represented groups (low socioeconomic status, non-academic medical centers, rural populations and ethnic minorities). With the advent of the 21st Century Cures Act, the field of secondary research has become increasingly systematized but issues remain with access, reproducibility, and data ownership. The value of real-world clinico-genomic datasets in understanding the utility of medical interventions in real-world clinical practice cannot be underestimated and is becoming increasingly relevant in therapeutic areas where traditional interventional research is not feasible or economically viable. Current approaches to the execution of ‘real-world data’ studies often lack engagement of subjects and are limited by institutional and technological “data siloes”. The GRECO study is a novel, patient-centered approach to accessing and understanding patient clinical data and developing more comprehensive clinico-genomic datasets. The GRECO study, sponsored by Guardant Health (GH), was designed as a pilot to investigate the feasibility and acceptability of a direct-to-patient approach to gain informed consent from patients to participate in a pragmatic study of individuals with a diagnosis of lung cancer and at least one GH diagnostic test with reported results (taken in the course of routine clinical care). Patients were contacted by a clinical research coordinator by both telephone and email within a 60-day window from the index date and invited to enroll in the study via an online study platform with IRB-approved eConsents and medical records release form. Recruitment of the IRB-approved pilot cohort was completed within six weeks. Medical records and imaging were obtained directly from providers identified by enrolled subjects, data abstracted electronically and manually with source document verification completed to ensure quality, and data reviewed. These data were combined with results from the GH database to develop a clinico-genomic database consisting of data from subjects who have willingly provided consent to have their data collected and studied for research purposes. Based on the result of this pilot, we believe the GRECO approach represents a novel approach to the execution of real-world data studies that engages patients as active and willing participants and results in a more comprehensive view of the longitudinal patient journey. The promise of real-world clinico-genomic data will only be realized fully if the centrality of the patient in the process is remembered. As a responsible data steward and with an organizational commitment to furthering the understanding of cancer and its treatment, GH believes that this novel approach to trial design, real-world data research and patient involvement could benefit many underserved and under-represented groups and bring valuable new insights to clinical care.

Citation Format: Linda Higashi, Naveen Kumar, Victoria Raymond, Mark Jacobstein, Kathryn Lang, Colin Small. GRECO: A novel patient-centered research methodology to broaden participation in clinical research [abstract]. In: Proceedings of the Twelfth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2019 Sep 20-23; San Francisco, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl_2):Abstract nr B040.