News
New AACI White Paper Addresses Persistent Barriers in Clinical Trial Start-up
AACI is pleased to share Accelerating Clinical Trial Activation: A Collaborative Framework for Managing Pre-Activation Protocol Amendments. This new white paper from the AACI Corporate Roundtable Trial Activation Task Force builds on AACI’s ongoing efforts to improve oncology clinical trial activation through benchmarking, collaboration, and innovation across North American cancer centers.
Since launching the AACI Clinical Trials Office Benchmarking Survey in 2018, AACI has supported members with comparative data on trial activation timelines, staffing, accruals, and operational efficiency. In parallel, the AACI Corporate Roundtable has convened leaders from academia, industry, and regulatory bodies to address persistent barriers in trial start-up.
Pre-activation protocol amendments frequently add weeks to clinical trial start-up timelines. Recognizing this significant contribution to activation delays, the task force drew on survey data and cross-sector collaboration to:
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Identify key process challenges impacting activation timelines
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Introduce a risk-based taxonomy (L1–L5) to guide amendment handling
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Recommend standardized "rules of engagement" across stakeholders
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Propose strategies to streamline communication, reduce duplicated work, and enable more efficient trial activation
AACI remains committed to collaborating and delivering practical solutions that accelerate clinical trials and improve patient access to innovative cancer therapies.