Undisclosed Primary End Point Changes Affect Clinical Trials

Anke Richters, PhD, from the Netherlands Comprehensive Cancer Organization, discusses how often primary end points are altered during clinical trials and why these changes may occur.

Among the trials that Dr. Richters and colleagues examined, 63% had altered end points. The trials, including IMvigor130, IMvigor211, KEYNOTE-045, and KEYNOTE-361, involved the investigation of immune checkpoint inhibitors in urothelial cancer. Most of the end point changes were related to the addition of a second outcome or multiple comparisons of different biomarkers.

Many end point alterations are not reported and can lead to downsides, such as a lack of quality control.