Dear CHANCE Colleagues,

Clinical trials are the gold standard in study design for evaluating the benefits and harms of interventions. The National Institutes of Health defines a clinical trial as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” The drugs, biologics, and devices that we use to treat or prevent diseases, lengthen our lives, or improve how we feel or function are evaluated using clinical trials. Behavioral and educational interventions are evaluated in clinical trials, too. Big elements in the clinical trial toolbox include randomization (possibly with stratification), blinding, the use of control groups, and prospective observation.

Statisticians have played a major role the development of the science of clinical trials. Methodologies for the design, conduct, analyses, and reporting of clinical trials are, in large part, developed by statisticians and biostatisticians. In this issue of CHANCE, we highlight clinical trials. I would like to acknowledge and thank our guest co-editor for this special issue, Professor Toshi Hamasaki, who is my close friend and colleague at the Biostatistics Center at the Milken Institute School of Public Health of George Washington University.

In our first article, Frank Bretz, Willi Mauer, and Dong Xi discuss “Replicability, Reproducibility, and Multiplicity in Drug Development,” an important topic given the pandemic of irreproducible research. Check out the cool graphics for illustrating multiple testing strategies! Mouna Akacha discusses “Choosing Measures of Treatment Benefit: Estimands and Beyond”—selecting an appropriate analysis population and the strategies to employ for missing data, depends on what you want to estimate. Yunyun Jiang and Dianne Uschner then tell us what romantic comedies can teach us about response adaptive randomization. Susan Halabi and Donna Niedzwiecki teach us about prognostic and predictive biomarkers and biomarker designs in “Advancing Precision Oncology through Biomarker-Driven Trials: Theory vs. Practice.” Lastly, I-Chun Lai, Chin-Fu Hsiao, Lih-Jiuan Hsu, and Churn-Shiouh Gau discuss clinical trials in global drug development and dealing with the challenging issue of geographic variation.

If you would like to learn more about clinical trials, please consider getting involved with the Society for Clinical Trials (www.sctweb.org).

In other articles, Amanda Hering and Daniel Cooley tell us about the two-decade history of a group of statisticians at the National Center for Atmospheric Research (NCAR). They describe the impact that the collaboration between statisticians and other scientists has had on atmospheric and climate science. Russell Campbell then contemplates when history occurs.

It is football season again. My Patriots are looking better than ever! However, one of the big headlines coming out of football is the impact of concussions on players. The NFL has been considering changes that would make the game safer. What changes would have an effect? Konstantinos Pelechrinis, Ronald Yuko, and Sam Ventura take a data-driven approach.

In the Taking a Chance in the Classroom column, Sarah McDonald and Nick Horton tell us about an activity that involved bringing data from cars.com into the classroom. The activities reinforce aspects of the GAISE report and including gathering real data, model building, and using technology.

Finally, this is my last issue as the executive editor of CHANCE. It has been a privilege to serve the profession and the ASA in this capacity. I have learned a lot, met many wonderful people, and had a lot of fun. I hope that you have enjoyed reading CHANCE and learned a few things, too. I thank you for this glorious opportunity and sharing the ride with me.

Scott Evans

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