Table 1.

Components of clinical trial eligibility criteria assertion model

	Concepts	Definitions	Examples
Core model concepts	Eligibility criteria assertion (ECA)	Structured diagnosis with or without associated biomarker criteria as described in the trial document	Breast Cancer: [ER Negative AND PR Negative AND HER2 Negative] AND [NONE: TP53 Germline Mutations]
	Treatment context assertion (TCA)	Combination of the intention of treatment or sequencing of treatment and the treatment agents themselves as described in the trial document	[Niraparib AND Radiation Therapy] AND [Adjuvant Setting]
	Treatment arm assertion (TAA)	Linking the patient population (diagnosis and biomarker criteria) and treatment arms outlined in clinical trial document. Achieved via linking the ECA & TCA	“Breast Cancer: [ER Negative AND PR Negative AND HER2 Negative] AND [NONE TP53 Somatic or Germline Mutations]” & “ [Niraparib AND Radiation Therapy] AND [Adjuvant Setting]”
Terminologies	Diagnosis	Solid tumor, hematologic or lymphoid malignancy. The mapping structure means that multiple disease synonyms will match to the same disease, ie, hepatic cancer, hepatic carcinoma, cancer of the liver, liver cancer, and hepatocellular carcinoma would all map to the concept of hepatocellular carcinoma	breast carcinoma, head and neck squamous cell carcinoma, acute myeloid leukemia
	Biomarker	Includes biomarkers related to gene variants (mutation, deletion, fusion, amplification, loss); protein variants (expression, over-expression, deficient expression); cytogenetic/chromosomal abnormalities (duplication, deletion, monosomy, trisomy, karyotype, translocations, inversions); viral markers (EBV, HPV, KSHV, MCPyV, etc.), serological (HLA, HLB markers), epigenetic markers (methylation status), specialty markers (microsatellite instability, tumor mutation, MMR status)	MYC amplification, MSH2 loss, ERBB2 overexpression, monosomy 7, complex karyotype, t(9; 11)(p21; q23), KMT2A Fusion, dup(1)(q10qter), EBV positive, HLA-A*02:05, MGMT promoter methylation positive, MSI-High, TMB-Low, dMMR
	Therapies	Any therapeutic approach used in clinical trial document and defined on NCIt including, but not limited to, targeted therapy, immunotherapy, hormonal therapy, cytotoxic agents, monoclonal antibodies, antibody-drug conjugates, vaccine therapy, and hematopoietic and bone marrow transplantation (surgical interventions and radiation therapy subtypes are excluded)	osimertinib, larotrectinib, tamoxifen, pembrolizumab, oxaliplatin, trastuzumab, brentuximab vedotin, Lu-177-DOTA-TATE, CAR T-cell therapy
	Therapeutic context	Describes the clinical context for treatment as would be relevant to a patient's disease state	Neoadjuvant, adjuvant, metastatic, treatment-naïve, relapse, refractory, etc.
Concept groups	Disease groups	A meaningful grouping of diagnoses usually based on organ systems, similarity of disease biology or other commonalities	Urinogenital Cancer group: Extragonadal Embryonal Carcinoma, Renal Pelvis and Ureter Carcinoma, Urothelial Carcinoma, Uterine Corpus Neuroendocrine Neoplasm, Bladder Small Cell Neuroendocrine Carcinoma, Cervix Carcinoma, Malignant Bladder Neoplasm, Malignant Ovarian Germ Cell Tumor, Malignant Renal Pelvis Neoplasm, Malignant Reproductive System Neoplasm, Malignant Ureter Neoplasm, Malignant Urethral Neoplasm, Ovarian Embryonal Carcinoma, Testicular Embryonal Carcinoma, Transitional Cell Carcinoma, Ureter Small Cell Carcinoma
	Biomarker groups	A grouping of biomarker concepts usually to accommodate biomarkers that frequently appear together in clinical trials, or are related via a single pathway, or are usually altered in a particular disease. Can also be used to accommodate NCCN-approved risk biomarker groups for prognostic risk or diagnostic classification	11q23 abnormalities: del(11)(q10), KMT2A-AFF1 Fusion, KMT2A Fusion, KMT2A-MLLT3 Fusion, inv(11)(p15q23), KMT2A-ELL Fusion, KMT2A-MLLT10 Fusion, KMT2A-MLLT1 Fusion, KMT2A-MLLT4 Fusion, t(10; 11)(p12; q23), t(11; 19)(q23; p13.1), t(11; 19)(q23; p13.3), t(4; 11)(q21; q23), t(6; 11)(q27; q23), t(9; 11)(p21; q23), Trisomy 11
	Drug groups	A grouping of drugs based on drug categories/classes that have similar mechanism of action or usually appear together in trial documents. Can accommodate drug groups that cannot be directly derived from the drug ontology in NCIt	FDA approved aromatase inhibitors: exemestane, anastrozole, letrozole.