ACT Brief: Persistent Barriers to Cancer Trial Participation, Clarifying IRT Data Ownership, and Clinical Trial Opportunities in Sub-Saharan Africa

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

• New insights from a video interview with Shanthi Sivendran, MD, MSCR, MBA, senior vice president for cancer care support at the American Cancer Society highlight that geography and trial centralization remain among the most difficult barriers to cancer trial participation. With approximately 80% of cancer care delivered in community settings, many trials remain concentrated in large academic centers, requiring repeated long-distance travel for patients. Proposed approaches include greater use of decentralized trial models, local access to routine procedures such as bloodwork, expanded telehealth visits, and earlier integration of clinical trials into standard treatment discussions.
• A new article on interactive response technology systems outlines growing compliance risks tied to unclear ownership of IRT data. Regulatory guidance from ICH GCP, FDA, MHRA, and the EU Clinical Trial Regulation distinguishes investigator-controlled, protocol-required subject data from sponsor-managed operational data such as investigational product inventory status. The article emphasizes that sponsor-led actions like kit quarantining or blocking for quality reasons do not require investigator authorization when no clinical data are altered, provided audit trails and site communication are maintained.
• And finally, recent data also underscore sub-Saharan Africa as an underutilized region for controlled clinical trials, representing just 1.1% of global trial activity despite extensive research infrastructure. Established site networks report informed consent rates above 80% and retention rates between 85% and 96%, supported by large trial-naïve patient populations and growing burdens of non-communicable diseases. Expanded use of African sites could support faster recruitment, improved retention, and broader representation in global drug development programs.

That’s all for today’s ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.