Key Insights on ICF
Meeting Date: 24 July 2025
Key Discussion Notes:
Implementation of an autopsy ICF might depend on optional or mandated nature of the autopsy.
One CRSC member reflected on an instance where autopsy/postmortem sample collection was mandated by the FDA and the respective language needed to be kept at the site level ICF despite push back from some site. In this case tissue collection was part of a Special Protocol Assessment (SPA).
Glioblastoma New Asset Strategy
Meeting Date: 27 August 2025
Key Takeaways
The team evaluated the benefits and challenges of a phase 0 micro dosing approach versus a direct phase 1 trial, emphasizing the importance of obtaining robust PK/PD data and ensuring patient safety.
The group recommended performing a thorough regulatory and cost analysis to guide the decision on trial design, weighing ethical and operational considerations.
The use of AI Platforms in Clinical Research
Meeting Date: 10 September 2025
Recommendations of potential AI platforms:
Members shared experiences using generative AI (ChatGPT, Gemini, Claude) for tasks such as:
Writing job descriptions, confirmation letters, and study documents.
Medical writing support (e.g., drafting CSRs and protocols).
