50: How Biostatistics Expertise Led to a Career of Propelling Ethical Clinical Trial Design: D. Ross Camidge, MD, PhD; and Tom Fleming, PhD
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50: How Biostatistics Expertise Led to a Career of Propelling Ethical Clinical Trial Design: D. Ross Camidge, MD, PhD; and Tom Fleming, PhD
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In this episode, Dr Camidge sat down with Tom Fleming, PhD, a professor of biostatistics at the University of Washington School of Public Health in Seattle.
Drs Camidge and Fleming discussed how Fleming's interest in biostatistics led to a multifaceted career in clinical trial design and analysis. Fleming pursued a PhD in math and statistics and spent his early career learning to bridge quantitative sciences with clinical medicine, working on landmark trials for adjuvant colon cancer and debunking megadoses of Vitamin C as a cancer treatment.
A primary focus of Fleming’s career was pioneering the use of Data Monitoring Committees (DMCs) in oncology research to safeguard patient interests and trial integrity, later convincing organizations like SWOG to adopt DMCs to prevent premature data releases and biases. He also co-developed the O'Brien-Fleming monitoring boundary, a statistical framework that allows trials to stop early for efficacy only when the signal is undeniably compelling, thereby protecting scientific rigor.
After moving to the University of Washington, Fleming expanded his focus into infectious diseases. He led international efforts that revolutionized HIV/AIDS prevention, including demonstrating a reduction in heterosexual transmission of the disease through antiretrovirals and significantly reducing mother-to-child transmission in resource-limited settings.
Fleming remains a staunch advocate for confirmatory trials and the use of overall survival as the "gold standard" end point, often expressing skepticism toward surrogate biomarkers like progression-free survival. In the episode, he emphasized that rigorous science is possible even in the most challenging environments, provided there is a commitment to clinical equipoise and high patient retention. Outside of his professional life, Fleming prioritizes family and coaches youth soccer teams, reflecting his belief in the power of collaboration.
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