Wednesday, May 17, 2023

Streamlining Clinical Trials: Enhancing Efficiency and Affordability for Medical Innovation

  • Randomized controlled trials (RCTs) have become more expensive, with median costs estimated at $41,413 per patient for trials conducted between 2015 and 2017.

  • Per-patient costs can reach up to $500,000 in some trials, compared to the typical $10,000 per patient in the past.

  • Structural reasons for increased costs include longer trial durations, a larger number of subjects, and a focus on chronic diseases and existing drugs.

  • Pharmaceutical companies have sought alternatives such as outsourcing trials or pursuing less burdensome forms of approval.

  • Cheaper yet rigorous trials have been demonstrated by examples such as the U.K. Recovery Trial and decentralized Covid-19 trials.

  • Proposed changes for addressing RCT costs include:

    • Deregulating clinical trial advertising.

    • Fixing tax disincentives for research participants.

    • Extending tax advantages for trial participation to increase socioeconomic diversity.

    • Requiring more Institutional Review Board (IRB) transparency.

    • Walking back FDA and congressional diversity mandates to avoid slowing trials and raising costs.

    • Affirming the FDA's commitment to modern trial monitoring methods, such as risk-based monitoring.

These changes aim to remove unnecessary barriers, make trials more affordable, and benefit patients, healthcare resources, and pharmaceutical companies.

 Clear the Way for Clinical Trials