In an era of individualized treatment for patients through “precision medicine,” collecting biological data and integrating analysis within the outcomes of clinical trials has gained a newfound importance. A new paper in Nicotine and Tobacco Research outlines a framework that offers practical advice to help do that.
“It’s clear that patients do not respond to treatment equally,” says Dr. Li-Shiun Chen, a researcher at Washington University in Saint Louis and lead author of the paper. “Knowing their biological markers is one of the keys for us to find the best matching treatment for our patients.”
This paper encourages treatment researchers to consider collecting biosamples and examining genotypes of their existing samples, as well as integrating genetic analyses into their study designs. The framework aligns with the objectives of the recently unveiled Precision Medicine Initiative, which calls for the integration of treatment and genetics research within the nicotine and tobacco-research community, according to Chen.
The paper, co-authored by UW-CTRI Director of Research Dr. Timothy Baker, notes several challenges researchers face in trying to integrate biological data, including: 1) obtaining adequate sample sizes, and 2) timing genomic assessments optimally during trial designs.
“Many modern human genetic discoveries are possible because many research participants and scientists are collaborating across disciplines and countries,” Chen said.
The paper’s authors write that while study designs can vary significantly, the framework supports ways for researchers and clinicians to realize the goals of the Precision Medicine Initiative.
“The collection of biological samples do require additional planning and funding, but this is definitely an important investment to move not only science but also good clinical care forward,” Chen said.