AMRC publishes positioning paper

Table of Contents

Summary

The traditional clinical trial model, which relies on independent sites and Principal Investigators (PIs), faces significant inefficiencies, including fragmented processes, delayed start-ups, administrative burdens, and high burnout rates. These inefficiencies contribute to trial delays, missed enrollment targets, and increased costs—estimated at $540,000 per day due to lost prescription sales and trial expenses.

The clinical trial landscape has grown more complex, with over 6,100 drugs in development in 2022 (almost double that of 2012) and increasing reliance on new therapeutic modalities. This complexity further widens the gap between high-performing and underperforming sites:

  • The top 16% of sites enroll over 50% of trial patients, while the bottom 20% contribute just 3%.

To address these challenges, the Association of Multisite Research Corporations (AMRC) advocates for the adoption of multisite clinical research corporations (MCRCs). MCRCs provide a centralized, standardized, and scalable solution that enhances efficiency, improves data quality, and supports PIs, while reducing burnout and administrative burdens.

Key Benefits of MCRCs

  1. Efficiency: Streamlined operations and reduced variability across sites accelerate trial timelines.
  2. Data Quality: Centralized processes enhance consistency, meeting regulatory expectations such as those outlined by the FDA.
  3. Support for PIs: MCRCs alleviate the burden on PIs, improving their experience and reducing burnout.
  4. Cost Reduction: By addressing inefficiencies, MCRCs reduce financial losses caused by delays.

AMRC’s Mission

AMRC seeks to improve the clinical trial ecosystem by advocating for MCRCs through:

  • Industry-wide best practices for operational efficiency.
  • Education and collaboration with Sponsors and CROs.
  • Accelerating the development of new therapies to benefit patients.

David Burrow, Director at the FDA, emphasizes the potential of MCRCs to “improve efficiency, enhance patient relationships, and reduce burnout,” aligning with regulatory goals.

By adopting the MCRC model, the industry can modernize clinical trials, ensuring faster, safer, and more efficient development of innovative therapies.