Lessons learned while starting multi-institutional genetics research in diverse populations: A report from the Clinical Sequencing Evidence-Generating Research (CSER) consortium

Heidi Russell; Hadley Stevens Smith; Jeannette T Bensen; Priyanka Murali; Bart S Ferket; Candice Finnila; Lucia A Hindorff; Nuriye Sahin-Hodoglugil

doi:10.1016/j.cct.2022.107063

Lessons learned while starting multi-institutional genetics research in diverse populations: A report from the Clinical Sequencing Evidence-Generating Research (CSER) consortium

Contemp Clin Trials. 2023 Feb:125:107063. doi: 10.1016/j.cct.2022.107063. Epub 2022 Dec 22.

Authors

Heidi Russell¹, Hadley Stevens Smith², Jeannette T Bensen³, Priyanka Murali⁴, Bart S Ferket⁵, Candice Finnila⁶, Lucia A Hindorff⁷, Nuriye Sahin-Hodoglugil⁸

Affiliations

¹ Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA. Electronic address: heidi.v.russell@uth.tmc.edu.
² Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX, USA.
³ Department of Epidemiology, University of North Carolina-Chapel Hill, Chapel Hill, NC, USA.
⁴ Department of Public Health Genetics, University of Washington, Seattle, WA, USA.
⁵ Institute for Healthcare Delivery Science, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
⁶ HudsonAlpha Institute for Biotechnology, Huntsville, AL, USA.
⁷ Division of Genomic Medicine, National Human Genome Research Institute, Bethesda, MD, USA.
⁸ Institute for Human Genetics, University of California-San Francisco, San Francisco, CA, USA.

Abstract

Background: Increasing diversity in clinical trial participation is necessary to improve health outcomes and requires addressing existing social, structural, and geographic barriers. The Clinical Sequencing Evidence-Generating Research Consortium (CSER) included six research projects to enroll historically underrepresented/underserved (UR/US) populations in clinical genomics research. Delays and project re-designs emerged shortly after work began. Understanding common experiences of these projects may inform future trial implementation.

Methods: Semi-structured interviews with six CSER principal investigators and seven project managers were performed. An interview guide included questions of research/clinical infrastructure, logistics across sites, language, communication, and allocation of grant-related resources. Interviews were recorded, transcribed verbatim; transcripts were analyzed using inductive coding, thematic analysis and consensus building.

Results: All projects collaborating with new clinical sub-sites to recruit UR/US populations. Refining trial logistics continued long after enrollment for all projects. Themes of challenges included: sub-site customization for workflow and genetics support, conflicting input from participant advisory groups and approval bodies, developing research personnel, complex data management structures, and external changes (e.g. subcontractors ending contracts) that required redesign. Themes of beneficial lessons included: domains with prior experience were easier, develop project champions at each sub-site, structure communication within the research team, and simplify research design when possible.

Conclusions: The operational aspects of expanding clinical research into novel sub-sites are significant and require investment of time and resources. The themes arising from these interviews suggest priority areas for more quantitative analyses in the future including multi-institutional approval policies and processes, data management structures, and incremental research complexity.

Keywords: Barriers; Clinical trial; Diverse population; Multi-institutional.

Publication types

Research Support, Non-U.S. Gov't
Research Support, N.I.H., Extramural

Abstract

Publication types

Grants and funding