[Local approval procedures act as a brake on RCTs]

Area of Science:

• Oncology
• Clinical Trials
• Health Services Research

Background:

• Large multicentre randomised controlled trials (RCTs) in the Netherlands face challenges due to significant local variations in approval processes.
• Previous reports noted differences in processing times and documentation, but costs and mandatory requirements were less understood.

Purpose of the Study:

• To evaluate the aspects of local approval procedures for two oncological multicentre RCTs.
• To assess processing times, documentation requirements, and associated costs for obtaining trial approval.

Main Methods:

• A retrospective, descriptive study evaluated local approval procedures for the CAIRO5 and CHARISMA trials.
• Data collected included time intervals between Medical Ethics Review Committee (METC) and Board of Directors (RvB) approval, document types/numbers, and charged costs.

Main Results:

• The median time from METC to RvB approval was 90 days (range: 4-312 days).
• Document requirements varied from 6-20 per centre, and costs ranged from €0-€1750, totaling €8575 across all procedures.
• Most centres did not charge any costs.

Conclusions:

• Approval procedures for multicentre clinical trials in the Netherlands exhibit considerable heterogeneity.
• Unpredictable processing times, documentation demands, and costs necessitate greater uniformity for efficient clinical trial conduct.