PCORI ChallengePatient-CenteredResearch ManagementGroup (PCRMG)Team: In2healthMembers: Hillel Bocian MD/MBA Danny Nguyen Pharm.D/MBAUniversity of Southern California
What is Patient-Centered Research Management Group (PCRMG)? PCRMG is a hybrid SMO-CRO (site management and contract research organizations) structure that will specialize in comparative effectiveness research. It will integrate the pharmaceutical company with the healthcare delivery system -- but most importantly, decisions will be patient-centered by incorporating patients in the decision-making roles. Care centers will use a pooled, interactive patient registry. Structure will provide numerous advantages by making patients crucial stakeholders in the design of comparative effectiveness trials. Integration of the systems will not only control costs and maximize clinical utility, but will also result in better outcomes for patients.
PCRMG Impact Healthcare Patients Pharmaceutical Industry Facilities/Investigators •Best practices created to help •Market segmentation and•Increased patient engagement optimize star ratings and mass reimbursement customization/personalization•Targeted/personalized therapies •Sources of revenue from •Superior targeting of niche running trials and any patient populations resulting intellectual property•Reduced costs •Reduced risk of adverse •Improves patient care and outcomes•Industry and care center documentation orientation towards patients. •Defrayed costs through •Evidence-based medicine vertical integration decision making
Risks and Threats? Collusion between investigators, healthcare facilities and industry to maximize revenue Patients are not technologically savvy enough to engage their online registry profile Increased cost to insurers and patients if trials are not run properly Regulatory barriers for patient confidentiality (HIPAA) Facilities and documentation standard will need to be raised for participating healthcare facilities IRB approval for multiple sites
Solutions Collusion between investigators, healthcare facilities and industry to maximize revenue? (risk sharing and coverage for therapies by industry) Patients are not technologically savvy enough to engage their online registry profile? (journals or voice recorded to be transcribed when brought in) increased cost to insurers and patients if trials are not run properly (industry may cover) Regulatory barriers such as HIPPA? (patient’s consent ) Facilities and documentation standard will need to be raised for participating healthcare facilities? (investment that will raise data gathering and clinical trial revenue) IRB approval for multiple sites (central IRB approval)
Current Problem Clinicaltrails are not patient centered Comparative-Effective research needs to grow Hospitals, Patients and Pharmaceutical Companies operate in silos
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