But there are so many settings in which P values are reported. OncoTherapy Network: Does statistical significance typically imply biological significance?ĭr.

ASCO’s perspective paper from 2014, “Raising the Bar for Clinical Trials by Defining Clinically Meaningful Outcomes,” addresses this problem by providing guidance for what would considered “clinically meaningful” in a number of different patient populations so that trials can be designed with an appropriate sample size. If the study is much larger or smaller than required to answer the primary research question, then the P value can be misleading on its own. P values are most useful in a setting where a trial was designed to have an appropriate sample size to address the primary objective of the study.

It is always important to consider the clinical effect size and sample size when interpreting a P value. Garrett-Mayer: P values can have some value, but should not be interpreted on their own. What is their value in assessing clinical trial outcomes in oncology?ĭr. OncoTherapy Network: Statistical P values and their interpretation have become somewhat controversial. Garrett-Mayer about concerns regarding statistical probability (P) values and “data dredging” in clinical research. She is a member of the American Society of Clinical Oncology (ASCO) Cancer Research Committee. Professor of Biostatistics and Epidemiology Elizabeth Garrett-Mayer, PhD, is Director of Biostatistics at the Medical University of South Carolina’s Hollings Cancer Center in Charleston, South Carolina.

, data dredging