PCORI Challenge

Patient-Centered Research Management Group (PCRMG)

Team: In2health Members: Hillel Bocian MD/MBA Danny Nguyen Pharm.D/MBA University 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

Patients

•Increased patient engagement •Targeted/personalized therapies •Reduced costs •Industry and care center orientation towards patients.

Healthcare Facilities/Investigators

•Best practices created to help optimize star ratings and reimbursement •Sources of revenue from running trials and any resulting intellectual property •Improves patient care and documentation •Evidence-based medicine decision making

Pharmaceutical Industry

•Market segmentation and mass customization/personalization •Superior targeting of niche patient populations •Reduced risk of adverse outcomes •Defrayed costs through vertical integration

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 Clinical trails are not patient centered Comparative-Effective research needs to

grow Hospitals, Patients and Pharmaceutical

Companies operate in silos