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An Overview of Genomic Biomarker Use in Cardiovascular Disease Clinical Trials
Author(s) -
Adeniyi Oluseyi,
Ramamoorthy Anuradha,
Schuck Robert,
Sun Jielin,
Wilson Jennifer,
Zineh Issam,
Pacanowski Michael
Publication year - 2019
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.1473
Subject(s) - biomarker , clinical trial , medicine , drug development , disease , drug , biomarker discovery , oncology , bioinformatics , computational biology , pharmacology , biology , genetics , gene , proteomics
Clinical trial designs targeting patient subgroups with certain genetic characteristics may enhance the efficiency of developing drugs for cardiovascular disease ( CVD ). To evaluate the extent to which genetic knowledge translates to the CVD pipeline, we analyzed how genomic biomarkers are utilized in trials. Phase II and III trial protocols for investigational new drugs for CVD and risk factors were evaluated for prospective and exploratory genomic biomarker use; drug targets were evaluated for the presence of evidence that genetic variations can impact CVD risk or drug response. We identified 134 programs (73 unique drug targets) and 147 clinical trials. Less than 1% ( n = 1/147) trials used a genomic biomarker prospectively for in‐trial enrichment despite 32% ( n = 23/73) of the drug targets having evidence of genetic variations. Additionally, 46% ( n = 68/147) of the trials specified exploratory biomarker use. The results highlight an opportunity for more targeted CVD drug development by leveraging genomic biomarker knowledge.