Ancillary/Correlative and Biomarker Studies

• Decision Tree for Determining the Need for LOI or Protocol Review by the Biomarker Review Committee (PDF)
• Biomarker Review Guidelines (MS Word)
• Study Checklist for Early Phase Trials with CTEP-Supported Biomarker Assays (MS Word)
• Correlative Science Proposal Submission Form (for ETCTN studies only) (MS Word)

Templates for Clinical Assay Development

The following templates have been prepared by groups of experts who are well known in their field of clinical pathology and are intended to document the characteristics of assays as they are to be performed in a CLIA-accredited laboratory. The templates are based on the MISFISHIE principles (Deutsch et al., 2008) and may be included as appendices for Letters of intent (LOIs), concepts or protocols when molecular diagnostics are proposed to be integral markers in clinical trials. If you have any questions or suggestions about the templates, please do not hesitate to contact Dr. Tracy Lively at Livelyt@mail.nih.gov.

• Template for DNA-based Mutation Assays (MS Word)
• Template for DNA-based In Situ Hybridization (FISH, CISH) (MS Word)
• Template for Immunohistochemistry (MS Word)