Clinical Research and Trials Unit

Our Clinical Research and Trials Unit (CRTU) provides experienced research administration, implementation, and coordination of clinical trials conducted in the KPNW care delivery system and at the CHR Research Clinic. Our CRTU works with physicians and CHR investigators, ensuring patient safety, compliance with regulations, and data integrity.

CHR began supporting clinical trials in 1972. Today, with research funding from federal and industry sponsors, the CRTU team supports all Phase 2 and 3 drug clinical trials and Class II and III device trials in the KPNW delivery system.

In 2025, CHR conducted 109 clinical trials spanning cancer, cardiovascular disease, diabetes, and infectious disease, among other areas.

Oncology

Thanks to CHR’s CRTU, KPNW is one of only 46 National Community Oncology Research Program (NCORP) sites across the U.S. NCORP is a national network within the National Cancer Institute that brings together cancer clinical trials and care delivery studies, focused on cancer prevention, screening, quality of life, and much more. Thanks to support from KPNW’s Community Health program, CHR is able to provide infrastructure and support for all NCORP trials in KPNW.

Why this matters for our members:

It provides access to high quality care and the latest cancer clinical trials.

Participants can help inform new treatment discoveries, national care standards, and improved cancer treatment guidelines.

Interventional Cardiology and Vascular Surgery

Thanks to CHR, KPNW physicians can offer KP members access to leading-edge cardiology, vascular surgery, and interventional neurology trials.

KPNW participated in 10 active cardiology trials testing drugs and devices in 2025. CHR also provides critical infrastructure support that allows members to receive Humanitarian Use Devices.

Why this matters:

• In 2025, we initialized the first year of our American Heart Association Aortic Stenosis registry. The aim of the registry is to better identify and treat patients with aortic stenosis, one of the most common and serious forms of heart disease. Participation in the registry also affords our clinicians access to the program’s resources, which aim to enhance patient experience from symptom onset to appropriate diagnosis, treatment, and disease management. This multi-year effort represents a strong partnership with our KPNW cardiology program, improving access to cardiac care for these patients.
• We also opened the first Lp(a) trial at KPNW, testing a novel drug to lower Lp(a), a genetically-inherited cholesterol particle in the blood that raises the risk of heart disease, stroke, and aortic valve stenosis. The trial gives patients the opportunity to participate, which will provide some with the drug and will allow all to help bring this drug to market, opening access for KPNW members in the future.
• CRTU’s efforts in cardiology contributed to Sunnyside Medical Center being awarded Healthgrades’ Cardiac Surgery Excellence Award in 2025.

The Kaiser Permanente Evidence-based Practice Center

CHR is the home of the Kaiser Permanente Evidence-based Practice Center (EPC), one of 11 centers nationwide designated by the Agency for Healthcare Research and Quality. The EPCs synthesize available scientific evidence on important health care topics. Their evidence reports are used to guide health care decision-making by clinicians, patients, and policymakers. The EPC is directed by Jennifer S. Lin, MD, MCR. In 2025:

• Our EPC reviewed and summarized the evidence on glucagon-like peptide-1 receptor agonist drugs (GLP1 RAs). This work supported Kaiser Permanente’s National Guideline Program to update its guideline on management of overweight and obesity in adults. Specifically, we developed a list of co-occurring conditions for special consideration in use of these drugs, as well as potential benefits of the drugs beyond blood sugar control and weight loss.
• Our EPC also investigated the use of Artificial Intelligence (AI) in systematic reviews. In a collaborative project, we reviewed studies of tools that use machine learning or AI to automate or semi-automate any part of evidence synthesis. The results will prevent duplication in efforts and help EPCs identify tools to improve efficiency. Our EPC also investigated AI-assisted versus human-only data extraction. We found that the AI-assisted method reduced data extraction time by a median of 41 minutes per study, with slighter greater accuracy, and fewer errors, showing this method may offer a viable, more efficient alternative to human-only methods.

• EPC Co-Associate Director Elizabeth O’Connor, PhD contributed to a World Health Organization publication that identified policies to reduce cancer burden due to alcohol consumption. After reviewing the evidence, twenty experts found that several policies reduced alcohol consumption, including increasing taxes, prices, and age for purchase or consumption, and reducing alcohol outlets and days or hours of sale.

Research Engagement, Assessment, Development and Interventions (READI)

Our READI Department delivers behavioral interventions in areas such as depression, insomnia, and managing chronic pain. Staff are trained in counseling and motivational interviewing, offering expertise in recruitment, qualitative interviewing, and focus-group facilitation, as well as Spanish language skills. Highlights from 2025 include:

• For the ARIA study of acute respiratory viruses among adults, dedicated READI recruitment staff successfully reached 75% of their goal of 7,000 participants—two months early. The funder has extended the study, and READI staff will continue recruiting through mid-2027.
• For the ORION study of acute gastroenteritis among adults, READI staff recruited more than 1,000 KPNW members in only two months, between January and March 2025. CHR’s skilled READI team also managed 3,555 total participants from four KP study sites, coordinating sample collection kits, weekly surveys, and compensation gift codes. Of the total, 82% of participants are still with the study.

Qualitative Research Core (Q-CORE)

By using a mix of qualitative approaches, from interviews and focus groups to ethnography and participatory engagement, CHR’s multi-disciplinary Qualitative Core helps us understand the nuances of health care and how they influence outcomes. In 2025:

• Based on their work studying use of a suicide risk prediction tool for adults, Senior Investigator Bobbi Jo Yarborough and Scott Stumbo, Collaborative Scientist III, were sought out to lead the qualitative analysis for a new project sponsored by the American Foundation for Suicide Prevention. The project will develop a suicide risk prediction model for youths and adolescents with Medicaid insurance. The team will conduct focus groups with patients, family members, health care providers, and Medicaid administrators. The results will inform strategies for implementing future risk models.
• Q-CORE began developing qualitative evidence synthesis capacity through a collaboration with Senior Investigator Jillian Henderson, who is leading a systematic review with colleagues at Oregon Health and Sciences University to understand the experiences of individuals who had to travel for abortion care. This global review of qualitative studies will offer health care providers and policy makers insight into the experiences of those affected by the need to travel for abortion care across a range of legal and social environments. The study results will inform health care providers, legal advocates, and policy makers on how best to support and improve the health and well-being of people seeking abortion care in restricted contexts. Q-CORE staff and investigators provide advice, input, and technical support.
• Q-CORE staff also supported submission of 12 research proposals with qualitative methods and published 9 papers on studies with qualitative components.

Translational and Applied Genomics (TAG)

CHR has a specialized team working to bring genetic advances into health care. Our TAG Department focuses on inherited conditions and risk factors for diseases, ways to improve diagnosis and management, and implementing new strategies into health care systems. We conduct studies within KPNW, as well as with other health systems, studying patients with and without health insurance from diverse backgrounds.

• The Connect for Cancer Prevention Study
  The Connect for Cancer Prevention Study is a study led by the National Cancer Institute (NCI) that seeks to learn more about what causes cancer and how to prevent it. NCI is partnering with ten health care systems across the U.S., including KPNW, to enroll healthy adults and follow them over time. The Connect Study began recruiting in 2021. As of December 2025, it has more than 87,000 enrollees, including more than 13,000 at KPNW, the second leading recruitment site.
  
  In 2025, CHR’s Connect team enrolled 3,979 KPNW members, making this our second highest enrollment year (after 2024). Our team contacted every eligible health plan member through phone calls, in-person events, and focus groups. They collected more than 3,580 blood, urine, and saliva samples from participants; 82% of participants returned samples. These samples will become part of a repository that allows researchers to better understand how cancer may develop.
• ClinGen
  ClinGen is an NIH-funded genetics knowledge base that defines the clinical relevance of genes and variants for use in precision medicine and research. CHR co-leads ClinGen’s Actionability Team, which brings international experts together to assess whether clinical interventions are available that could prevent or reduce the harm caused by a genetic variant that confers high risk of disease. This work supports doctors and laboratories to determine which genetic tests are of value to patient health. In 2025, our team published reports on 26 genetic conditions. Highlights include a long-awaited report on sickle cell anemia and our first report on a chromosomal abnormality. Our team also developed a framework to assess polygenic risk scores. Finally, we published a paper describing the design and implementation of the ClinGen Consortium action plan to increase equity, diversity, and inclusion in genetic research data and the ClinGen workforce.

Compliance

As we integrate research within the care delivery system, cultivating a strong partnership with CHR Research Compliance enables KPNW to protect the most valuable resource we have: our members’ trust.

Our Research Compliance team serves a critical role in helping to ensure that projects, whether Quality Improvement (QI) or research, are conducted in compliance with applicable institutional policies and procedures, as well as federal and state regulations and guidelines.

Here is how the team supported compliance oversight and reduced institutional risk in 2025:

• Quality Improvement
  CHR‘s Research Compliance team provides guidance for effective and compliant quality improvement project design and implementation. We are also trusted partners with clinicians in the delivery system — for example, in 2025, we partnered with pharmacy and nursing leads to determine the feasibility of capstone projects for staff working toward advanced degrees as well as certifications for KP Magnet status.
• Research (Internal, External)
  In 2025, the Research Compliance team also supported submissions for formal regulatory oversight, facilitated compliance with annual reviews, study modifications, and closure reports for projects under Institutional Review Board oversight, ensured KP data was appropriately protected when shared, with data sharing agreements in place, and supported researchers in understanding and navigating both FDA regulations and KP institutional technology review requirements for artificial intelligence and machine learning.

Center for Effectiveness and Safety Research (CESR)

CHR researchers, working within the KPNW region, regularly collaborate with researchers in the other KP regions—Hawaii, Washington, Mid-Atlantic, Northern California, Southern California, Colorado, and Georgia. As the Data Coordinating Center (DCC) for KP’s Center for Effectiveness and Safety Research (CESR), CHR maintains the quality of the KP Virtual Data Warehouse (VDW), a curated, research-ready data repository designed to produce comparable data across all KP regions. CHR also serves as the programming lead for enterprise efforts, such as Healthy Life Years and Cancer Metrics and Outcomes, that generate KP-wide metrics using VDW data, and supports the data infrastructure and provisioning for the KP Research Biobank (KPRB).

Health Care Systems Research Network (HCSRN)

CHR is a founding member of the HCSRN, a group of 20 nonprofit health care delivery systems sharing resources and clinical information to better inform health research. HCSRN is recognized as a premier national source of population-based research.

National Dental Practice-Based Research Network

The National Dental Practice-Based Research Network (funded by the National Institute of Dental and Craniofacial Research) is a consortium of more than 9,000 dentists, hygienists, and other professionals committed to advancing dental practice. CHR coordinates the Network’s Western Region Node; CHR Investigator David Mosen is the region’s director.

CHR also serves as the Data Coordinating Center (DCC) for the national network. The coordinating center has managed data collection and other study-relate

OCHIN

CHR has a formal collaboration with OCHIN, which provides technology support to more than 2200 health care delivery sites across the U.S. serving underinsured and uninsured patients. This collaboration allows researchers at both organizations to conduct comparative research between two very different health systems. Frances Lynch, PhD, a Distinguished Investigator at CHR, also holds an appointment as a Senior Investigator at OCHIN.

Social Needs Network for Evaluation and Translation (SONNET)

CHR investigators are active members of KP’s SONNET, a national network that supports initiatives to address KP members’ essential needs. Supported by KP’s National Community Health Program, SONNET helps KP researchers, leaders, and medical professionals design, evaluate, and learn from initiatives that address needs such as social connection, food, housing, and transportation. CHR Investigator David Mosen, PhD, represents CHR on SONNET’s Evaluation & Research Committee.

Tufts Clinical and Translational Science Institute

CHR has been a member of the Tufts CTSI since 2023. Through this affiliation, CHR’s investigators and staff have access to a broad range of research collaborators, opportunities, and resources. As a member of the Tufts CTSI, CHR also makes its biospecimen resources and expertise in qualitative and mixed-methods research available to other members. Carmit McMullen, PhD is CHR Site PI and directs the Qualitative and Mixed Methods Consulting Service. With help from Q-CORE colleagues, Dr. McMullen has produced a series of trainings on qualitative interviewing that are available for free on Tufts CTSI I LEARN and has facilitated a monthly qualitative research interest group, open to all, that currently convenes researchers from across the country

Vaccine Safety Datalink

CHR is an active member of the Vaccine Safety Datalink, a collaborative project among the Centers for Disease Control and Prevention (CDC) and thirteen health care organizations using large medical records databases to monitor vaccine safety in the U.S. Distinguished Investigator Allison Naleway, PhD, is the Principal Investigator at CHR.

VISION

The CDC’s VISION Network (Virtual SARS-CoV-2, Influenza, and Other Respiratory Viruses Network) is a national research collaboration that links electronic health, laboratory, and vaccination records from multiple U.S. health systems, including KPNW. Established in 2019, it is used to evaluate the real world effectiveness of vaccines and preventive products against severe outcomes from illnesses such as COVID 19, influenza, and RSV. Findings from the VISION Network help inform CDC vaccine recommendations and public health policy.