New clinical trial recruitment approach, approved by WCG IRB, focuses on connecting health center communities with clinical research
par8o, the largest provider of referral management technologies for large health systems and self-insured employers, today announces the launch of par8o Research Network (PRN), a clinical trial recruitment service that connects health center patients with nearby trials. Notably, to ensure both HIPAA and ethical compliance, par8o’s patient outreach and engagement protocol has been reviewed and approved by an independent Institutional Review Board, WCG IRB.
As a well-established partner to the nation’s leading health systems since 2011, par8o has demonstrated that its technology can be transformative. Over the last three years, the company has leveraged its expertise to assist community health centers with capturing savings for their 340B programs through prescriptions that result from referrals. Today, par8o serves over 130 health center clients across 35 states, translating to more than 7 million underinsured, uninsured or publicly insured patient lives. With the launch of PRN, par8o will apply its expertise to solve a major issue in clinical trials—namely, the lack of racial, ethnic and socioeconomic diversity.
"The lack of diversity in clinical research not only increases drug costs due to failed recruitment targets and delayed timelines, but also creates an ongoing legacy of healthcare injustice against minority groups," said par8o CEO, Dr. Daniel Palestrant, MD. "It’s well known that different racial and ethnic groups can respond differently to the same treatments. Under-representation of minority groups in a clinical trial can create a legacy of bad data, which can ultimately impact patient access to therapeutics. We are confident that PRN will move the needle on the lack of diverse racial and ethnic representation in clinical trials."
Clinical research and development diversity statistics are alarming: Out of 31 cancer treatments approved in the United States since 2015, 24 of the related clinical trials included fewer than 5% Blacks, despite Blacks making up 13.4% of the US population. Further, one in five FDA approvals differ in exposure and response as a function of racial and ethnic under-representation, according to a 2015 report published by Clinical Pharmacology & Therapeutics.
"Clinical trial recruitment is difficult and recruiting racially-diverse and representative participants is even more challenging, but the sense of urgency for diversity in clinical trials has grown significantly during the COVID-19 pandemic," said Craig Lipset, adjunct assistant professor, Rutgers University and former head of clinical innovation, Pfizer. "PRN brings trusted relationships with community-based health centers that have been on the sidelines for clinical trials, but when coupled with technology create a unique opportunity to improve diversity in trial participation and take a significant step forward in addressing racial disparities in healthcare."
Health Center Patients: More Likely to Be Affected, Less Likely to Be Included
Health center patients are increasingly diverse: The National Association of Community Health Centers 2020 Chart Book reported health center patients are 41% White, 36% Latino/Hispanic, and 22% Black, with 91% at or below 200% of the federal poverty level. Yet Black, Native American, and Latinx patients are far less likely than White patients to encounter or participate in clinical trial opportunities.
"PRN approaches a healthcare challenge that is hampered with a long history of trust and access issues," said Melissa Opraseuth, Pharm D. and par8o COO. "Health centers are integral to the communities they serve and have earned the trust of their patients. PRN builds upon this trust by providing a way for health centers to promote equal access to clinical trials for their patients."
Streamlining Trial Participant Identification
When a health center joins PRN, par8o works with the health center to analyze electronic health record (EHR) data to identify patients who might be candidates for nearby trials. From there, par8o has built a workflow which leverages its expertise in patient referral management and care coordination that enables providers and patients to seamlessly qualify for and participate in clinical trial opportunities.
Healthcare technology company par8o was founded in 2011 with the mission of applying the Pareto optimality concept to healthcare. Its flagship product, CareCompass, optimizes patient referrals through intelligent specialist recommendations, patient engagement and care coordination, and has processed over 3 million referrals across 42 states. In 2017, par8o introduced 340B Referral Capture, leveraging EHR and third-party administrator (TPA) integration, care coordination expertise and automation to help health centers capture 340B revenue from referrals. par8o currently serves over 130 of the nation’s health centers at over 2,000 locations in 35 states, covering almost 7 million patient lives.
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Ryan Mckenna, Senior Account Manager