• The Evolving Reimbursement Landscape — Considerations For Clinical Trial Design

    Sponsor companies are increasingly examining ways to integrate the payer community’s point of view into clinical development activities, a trend that could improve the chances a drug will gain market access, achieve faster adoption once launched, and better meet patient needs. With payers increasingly demanding evidence of a drug’s value before they will cover a marketed product, demonstrating both better clinical and economic benefits of a treatment takes on greater significance.

  • 3 Steps To Capitalize On Real-World Data Under 21st Century Cures

    Randomized clinical trials (RCTs) of prescription drugs and other medical products have been considered the gold standard of evidence to support decision making by clinicians and policymakers. However, it is increasingly recognized that most RCTs are unable to generate information about a product’s real-world effectiveness. Measures such as long-term outcomes, comparisons among multiple treatment options, and utilization are not well captured in trials. Furthermore, benefit-risk balance and value for money are best learned in cost-effectiveness or cost-benefit analyses.

  • Why Pharma Needs A New Approach To Patient Engagement In Drug Development

    Pharmaceutical companies face many challenges: developing life-changing products that meet the needs of patients, physicians, and payers; adhering to regulatory standards; and managing health technology and payer scrutiny, all while trying to satisfy investors. As drug prices seem to be continually rising, many health plans are shifting more of the cost-sharing burden to patients.  As a result, the patient is becoming more of a “consumer” in the traditional sense.


Dominic Galante

Dominic Galante, M.D., is chief medical officer of quality and population health solutions at Precision for Value. He is a leading authority in managed care, pharmaceutical markets, clinical quality management, healthcare provider performance-based delivery and reimbursement models, healthcare system migrations, community health alliances, organizational change, communications, and medical marketing.