Core-006

NIH RePORTER · NIH · UL1 · $677,374 · view on reporter.nih.gov ↗

Abstract

OCTRI has been a leader within OHSU in creating the foundation for effective and efficient single- and multicenter clinical trials. These ongoing efforts include implementation of OHSU’s electronic Clinical Research Information System (eCRIS), and implementing single IRB review models and master contracts. However, numerous challenges remain in developing, testing, implementing, and disseminating optimal procedures for supporting clinical trials. Building on ongoing successful efforts, OCTRI will create the Liaison to Trial Innovation Centers (LTICs). LTICs will be part of the newly created Office of Clinical Research (OCR), which will streamline and facilitate study start-up and implementation, employing process reengineering to decrease the cycle time for start-up activities and increase the amount of work conducted in parallel. The OCR will provide local support for clinical research studies, and, as the LTICs, also interface to the CTSA Trial Innovation Centers (TICs) to enhance clinical trials operations at OHSU, with regional partners and the community, and with the CTSA network. These efforts will be continually tested and validated for effectiveness, and will be shared with the CTSA network. This will ultimately contribute to improved human health via faster and more productive clinical trials that lead to new therapeutics. OCTRI has many ongoing initiatives to identify and address barriers to enrollment/retention of subjects into clinical research studies. These include surveys and focus groups; feedback to department directors; design and implementation of informatics-based recruitment tools through the OHSU Electronic Health Record (including a recent randomized trial of direct recruitment of patients via the Epic MyChart patient portal); assistance with experimental design and operational implementation, identification of resources; assignment of experienced regulatory and study coordinator staff to high priority protocols; and partnerships with community medical centers. However, these efforts are somewhat fragmented, and need to be expanded to meet CTSA network initiatives. Building on these continuing efforts, OCTRI will create a Recruitment Core that will function as the Liaison to Recruitment Innovation Centers (LRICs). This unit will be staffed by experienced personnel skilled in recruitment and retention of research subjects, and will provide consultation to investigators to assess recruitment feasibility and implement recruitment using tested and proven methods tailored to individual needs, will enhance current strengths in utilizing OHSU’s EHR (Epic) for recruitment and retention, and will function as the liaison with the CTSA Network Recruitment Innovation Centers (RICs). These efforts will be continually tested and validated for effectiveness, and will be shared with the CTSA network. This will ultimately contribute to improved human health via faster recruitment and attainment of enrollment goals, which will lead to new th...

Key facts

NIH application ID
10191102
Project number
5UL1TR002369-04
Recipient
OREGON HEALTH & SCIENCE UNIVERSITY
Principal Investigator
David Hoadley Ellison
Activity code
UL1
Funding institute
NIH
Fiscal year
2020
Award amount
$677,374
Award type
5
Project period
— → —