TY - JOUR
T1 - Lessons learned while starting multi-institutional genetics research in diverse populations
T2 - A report from the Clinical Sequencing Evidence-Generating Research (CSER) consortium
AU - Russell, Heidi
AU - Smith, Hadley Stevens
AU - Bensen, Jeannette T.
AU - Murali, Priyanka
AU - Ferket, Bart S.
AU - Finnila, Candice
AU - Hindorff, Lucia A.
AU - Sahin-Hodoglugil, Nuriye
N1 - Funding Information:
The Clinical Sequencing Evidence-Generating Research Consortium (CSER), multi-institutional collaborative research program funded by the National Institutes of Health, focuses on implementing genomic technology in clinical settings[ 8 ]. The second phase of CSER prioritized enrollment of UR/US populations in its request for applications by expecting projects to “recruit a minimum of 60% of patients who come from racial or ethnic minority populations, underserved populations, or populations who experience poorer medical outcomes”[ 9 ]. In 2017, six projects were funded for this second phase of the consortium, each project with its own clinical indications for genomic testing [ 10 , 11 ] but with similar operational aspects at the local, multi-institutional, and consortium levels ( Fig. 1 ). Each project included a multi-disciplinary core of investigators and research staff responsible for the design, implementation, and oversight of individual projects and cross-consortium research questions. Projects were at the interface of research and clinical care at multiple sub-sites; five projects closely integrated into clinical care and one project relied on clinicians to identify and refer potential participants to a web-based research interface. All projects formed new collaborations with clinical sub-sites to reach UR/US populations. Finally, research participants interacted with research through four basic steps: 1) participants were identified, screened and enrolled if eligible and willing; 2) specimens were collected for genomic studies and delivered to the project-specified clinical laboratory(ies) for processing and analysis; 3) results of genomic tests were returned to the participant and clinical provider; 4) participants completed project-specific and consortium-level surveys.
Funding Information:
Another institutional barrier was the inability to begin work until grant funding was in-hand. At some institutions this included posting for new positions or developing data management structures. Early delays in developing central project infrastructure will likely amplify downstream delays at sub-sites, especially at those sub-sites with less marginal support for research personnel. Failure to prepare for institutional delays may result in unrealistic expectations around time required to be “up and running.”
Publisher Copyright:
© 2022 Elsevier Inc.
PY - 2023/2
Y1 - 2023/2
N2 - 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.
AB - 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.
KW - Barriers
KW - Clinical trial
KW - Diverse population
KW - Multi-institutional
UR - http://www.scopus.com/inward/record.url?scp=85145188774&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2022.107063
DO - 10.1016/j.cct.2022.107063
M3 - Article
C2 - 36567057
AN - SCOPUS:85145188774
SN - 1551-7144
VL - 125
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 107063
ER -