Now is the time to fix the evidence generation system

Area of Science:

• Biomedical Science
• Health Outcomes Research
• Clinical Research Enterprise

Background:

• Despite scientific progress, health outcomes and life expectancy in the US lag behind peer nations.
• Significant health disparities persist based on race, socioeconomic status, education, and geography.

Purpose of the Study:

• To identify critical areas for reforming the clinical research enterprise.
• To improve the translation of biomedical research into effective health interventions.
• To address systemic issues hindering timely and equitable health improvements.

Main Methods:

• Analysis of the current clinical research system, focusing on premarket and postmarket evidence generation.
• Identification of key domains for improvement: data integration, patient/clinician involvement, and ethical data sharing.
• Assessment of systemic suboptimization and the need for integrated incentives.

Main Results:

• The postmarket phase of evidence generation is disaggregated and inadequate for optimal care.
• Key reform areas include integrating diverse data sources (trials, EHRs, wearables), restructuring operations for patient/clinician engagement, and enabling responsible data sharing.
• Addressing systemic suboptimization is essential for progress.

Conclusions:

• A major reformation of the clinical research enterprise is necessary to improve US health outcomes.
• Integrating data, engaging patients and clinicians, and promoting ethical data sharing are vital.
• System-wide incentives for integration and sharing are critical for timely and equitable health advancements.