- 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.