Working at Axio Research, a contract research organization that provides biostatistical support to facilitate clinical trials, Navneet Hakhu (MS, Biostatistics ’14) serves as an independent statistical data analysis center (SDAC) biostatistician for clinical trial research.

The studies are sponsored by pharmaceutical companies or government agencies and require a data monitoring committee (DMC) to assess risk-benefit and protect the interests of participating patients.  Hakhu joined Seattle-based Axio as a biostatistician over two years ago, and now is also a project manager.

Hakhu’s work as an SDAC biostatistician on clinical trials has encompassed several medical branches, including oncology, rheumatology, cardiology, immunology and hematology, among others. "It is interesting to see the variety of study designs and methods of analysis chosen by sponsors for clinical trials in the same or similar disease areas as well as what is focused on to enhance and maintain study conduct," Hakhu says.

He emphasizes the importance of "identifying the scientific question of interest that best aligns with the overall goal and primary aim of the study" and selecting endpoints that have clinical meaning. He added that identifying a balance between "data currentness—how up to date the data is—versus data cleanliness—the number of outstanding data queries—versus data completeness" are all critical for the reports Axio presents to the DMC, and for the ability of the DMC to make recommendations to the sponsor.

Study design, conduct during the trial, and appropriate pre-specified analyses all impact "a trial’s ability to generalize to the larger target population beyond the clinical trial setting.

Hakhu finds that the fast-paced, deliverable-driven biopharmaceutical industry suits him. "Even more importantly," he said, is that "as an independent biostatistician, I am able to help patients and improve public health."

(By Laura Cooley)