2. 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.
3. 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
4. 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
5. 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)
6. Current Problem
Clinicaltrails are not patient centered
Comparative-Effective research needs to
grow
Hospitals, Patients and Pharmaceutical
Companies operate in silos
