Dr. Langer on Assessing Patient Populations in Trials

Corey J. Langer, MD, Professor of Medicine, Director, Thoracic Oncology, Abramson Cancer Center, University of Pennsylvania, explains the importance of assessing the patient populations in clinical trials. If the population is not representative of the patients you see in your practice it may not be relevant to you.

The demographics of the patients entered into a trial may have a direct bearing on the outcome. As an example Langer uses a study by Chandra Belani, MD, which examined continuation maintenance therapy using gemcitabine and carboplatin.

The population of this trial contained somewhat older patients with a marginal performance status (PS) of 2. This trial did not show an improvement in progression-free survival or overall survival and closed earlier than planned, unlike other similar trials. It is suggested that the higher PS of the patients enrolled had a negative effect on the outcome of the trial.