How do you match up the appropriate patient with the right drug and implement treatment rapidly? That is a question at the heart of personalized medicine and the focus of a study by Quintiles to develop best practice
In a study of patients with colorectal cancer, it’s investigating how pre-profiling and genomic sequencing data, including the number of genetic changes that occur, could support physician treatment decisions, including the identification of appropriate clinical trials for patients. The Feasibility study of Biomarker Analysis for Patients with Metastatic Colorectal Cancer is expected to go on for 10 weeks. US Oncology Research is participating in the study and it’s supported by McKesson Specialty Health and the US Oncology Network.
The tumor analysis and assessing the bioanalytic requirements is done in Quintiles labs in Durham, North Carolina. Those observations and assessments are being packaged into a report for physicians.
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In a phone interview with Quintiles Chief Medical and Science Officer Jeffrey Spaeder, he said: “Instead of looking at just one biomarker and method of action and determining if the patient is appropriate for inclusion in a study, we are looking at a much larger number of genomic variants and allowing the healthcare provider and patient to make more informed decisions about [which treatment to go forward with.”
It’s about matching FDA-approved therapies, as well as therapies in development that have a specific benefit-risk profile for specific patient populations. Instead of bench to bedside, it’s more like bedside to bench and back again.
Spaeder said: “We have the capabilities to do this appropriately and think it is a new way of providing information to the treatment of patients and clinical research.”
Many groups see the benefit of personalized medicine since, based on our genetic makeup, two people with the same condition are likely to respond better to one treatment than another. But one of the challenges has been how to implement that approach. The Quintiles study represents an important piece of that puzzle.