St. Jude first to describe new statistical method

Statisticians at St. Jude Children's Research Hospital have developed a new technique that allows researchers to statistically analyze results of clinical trials. In it, all participants receive a new treatment and none are assigned to a control group getting the existing treatment. Instead, the treatment group is compared with a so-called "historical control" composed of patients who received the existing treatment in a previous study.

A report on this new method appears in the August issue of Statistics in Medicine.

The St. Jude report is the first to describe this novel statistical method called sequential interim analysis using a historical control group, the authors said. In an interim analysis, researchers statistically analyze the accumulating results of the clinical trial at several points during the course of the study, rather than wait until the end of the trial to determine if the trial should be stopped early.

The new statistical tool allows researchers to make a new treatment available to everyone in the study while still adhering closely to the gold standard of clinical study designs--the prospective randomized controlled trial (RCT), according to Xiaoping Xiong, Ph.D., associate member of the St. Jude Department of Biostatistics and the paper's first author. In an RCT, participants are randomly assigned to either the group that receives the new treatment or the group that does not.

"It's not always possible to do a standard RCT when there are a limited number of patients available to participate, or when patients do very poorly on the standard treatment that the new treatment is intended to replace," Xiong said. "In such cases, the best option is to design a trial that allows all participants to get the new treatment and use previously treated patients as a historical control group."

Until now, there were no statistically valid methods that included interim analysis in the design of c

Contact: Bonnie Kourvelas
St. Jude Children's Research Hospital

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