Shortcomings with time-to-event analyses in clinical trial publications

A team of researchers, including German Institute for Quality and Efficiency in Health Care (IQWiG) biometrician Ralf Bender, has demonstrated that shortcomings in the documentation of time-to-event outcomes in clinical trials also affect systematic reviews.

Many analyses in clinical research include so-called time-to-event (TTE) data, which indicate how much time has elapsed before an event occurs. A well-known example of such TTE analyses are survival curves estimated using the Kaplan-Meier method, which show how the proportion of surviving patients in the intervention and control group of a randomized controlled trial develops over time.

It has been known for some time that TTE outcomes in studies are often reported incompletely and unsystematically. In an article published in the Journal of Clinical Epidemiology, a team of researchers – including Ralf Bender, head of medical biometry at the Institute for Quality and Efficiency in Health Care (IQWiG) – has now investigated whether these shortcomings are also found in clinical trial publications included in systematic reviews.