Accrual-Monitoring Practices for Various Disease Trials among AACI Member Cancer Centers

Area of Science:

• Oncology
• Clinical Trial Management
• Rare Diseases

Background:

• Clinical trials are crucial for advancing rare disease and rare cancer management.
• Insufficient patient accrual (up to 32%) leads to trial incompletion and non-publication.
• Monitoring practices for clinical trials can vary across institutions.

Purpose of the Study:

• To survey regulatory standards for different trial types at major U.S. cancer centers.
• To understand institutional approaches to rare disease trial accrual and monitoring.

Main Methods:

• A 10-question survey was administered using Qualtrics.
• The survey targeted member institutions of the Association of American Cancer Institutes (AACI).
• Data were collected from 32 out of 103 AACI centers (31% response rate).

Main Results:

• Significant differences were observed in rare disease definitions and expectations for rare tumor studies.
• Accrual monitoring frequency by institutional Protocol Review and Monitoring Committees varied.
• Most respondents (73%) did not discontinue trials solely due to low patient accrual.

Conclusions:

• Institutional practices regarding rare disease definitions and trial monitoring are inconsistent.
• Strategies like investigator incentives (37%) and penalties (13%) are employed to optimize accrual.
• Further standardization may be needed to improve rare disease clinical trial success rates.