Cancer Genomics: Conducting Exemplary Trials With Biospecimen and Biomarker Components

TheNationalCancerInstitutehasarticulatedagoaltotranslate what we learn about genomic changes associated with cancer intonovelpreventive,diagnostic,andtherapeuticinterventions for patients with cancer. 1 Achieving this strategic goal requires increased collection and analysis of biospecimens and biomarkers in cancer clinical trials. Because of the magnitude of this topic, two articles in the Attributes of Exemplary Research serieswillbededicatedtothissubject. 2 Thefirstarticle,presented here, focuses on procedural requirements of clinical trials with biospecimen and biomarker components. The next article in the series will focus on ethical and legal concerns and share practicaltipsfortalkingwithpatientsaboutparticipation.Both articles incorporate advice from experts and present resources helpful to sites that conduct clinical research. Cancer trials incorporating biospecimen and biomarker components allow researchers to integrate knowledge about cancer cell biology and its impact on treatment options and patient prognosis. Through this new understanding, novel treatment options may be developed to target specific pathways that are dysregulated in cancer cells. Additionally, biomarker tests may help identify patients with specific mutations or abnormal protein expression in certain cell pathways, allowing individualization of therapies addressing specific abnormalities. Outcomes from these clinical trials continue to advance oncology care and predict which treatments will provide the greatest disease response and least toxicity for patients. Participation in these clinical trials helps physicians gain a professional advantage by contributing to the discovery of emerging treatments and gaining experience using predictive indicators long before they become standard care. Experience gained through these research studies prepares physician researchers for the future of cancer care and enables them to provide patients with the best possible treatment options.