Investigator Initiated Study – Oncology, non-compound specific

In scope:

• General
• • General report improvement and result interpretation initiatives
  • Quality-focused research designed to improve/align testing to guidelines and/or best practices
  • Economic analysis of adoption of novel diagnostic pathways or technologies (stage and/or disease agnostic)
• New technology
  • Artificial Intelligence (AI)* & digital path (e.g., image storage, Quality Assurance, etc.)
  • Minimal Residual Disease (e.g., early breast cancer, lung)
• Testing algorithms
  • Implementing software solutions (e.g., clinical decision support (CDS)**, reflex testing protocol, etc.)
  • Validating novel and practical analytical and informatics approaches to improve biomarker detection in tumor or plasma samples
  • Best practices for molecular testing to become routine in solid tumors
    • Testing pathways/protocols prior to neoadjuvant
    • Liquid Biopsy analytical performance (early-stage cancers)
    • Novel IHC algorithms applicable to Lilly’s oncology portfolio

Out of Scope:

• Next Generation Sequencing assay validation
• Synthetic control generation

*AI proposals will be subject to review by Lilly’s AI governance group to ensure transparency, accountability, compliance with regulatory and legal requirements, and alignment with Lilly’s objectives and policies.

**Any CDS solutions are to be evaluated pre/post implementation. Patient outcomes are not to be linked in CDS projects