Smart Patients Get Smart Care™

The World’s Leading Authority for Chronic Lymphocytic Leukemia Patients

ASH 2018: Dr. Nabhan on Patient Reported Outcomes (PROs) in Malignant Hematology

In science and medicine, information is constantly changing and may become out-of-date as new data emerge. All articles and interviews are informational only, should never be considered medical advice, and should never be acted on without review with your health care team.

At ASH 2018, Dr. Nabhan discussed the importance of Patient Reported Outcomes or PROs in not only research, but in improving patient outcomes.

It should be obvious that the best source of information about patient outcomes is listening to the patients.

Research has shown that simply listening to the patient and intervening when they were symptomatic improved survival by 4 months in patients with metastatic solid tumors. Drugs that improve survival by 2 months are approved, and here we have a simple common-sense no cost intervention that keeps folks alive longer.

PROs are supposed to be part of drug development and even included on the medications label, but it is not happening as much as it should.


  • Between 2011 and 2017, 250 new drugs were approved, of which 22 or 9% were approved for hematologic malignancies.
  • 13 of the 22 drugs (59%) collected PRO data in pivotal trials that led to their approval.
  • More trials are including PRO data in recent years.
  • Only 1 had PRO included in its label.


PRO data should be part of every trial, and it should be usable data that has been validated and can be reproduced.

There are many reasons that this is not happening, lack of direction from the FDA, lack of agreed tools to use, and lack of expertise on part of the researchers.

Let’s make sure lack of a push from patients is not one more reason. We at the CLL Society are hoping to do more PRO research in 2020 and will need your help to make it happen.

On a side note, Dr. Nabhan was a strong clinician and a highly regarded researcher who, like me, left direct patient care to do work at an institutional level to help patients, in my case in the nonprofit world, in his case in the commercial cancer drug development world where he provides “insights that improve the way new therapeutic advances are developed and delivered.”

Here is my ASH 2018 interview with Dr. Nabhan:

Here is ASH abstract: Patient-Reported Outcome Labeling for Malignant Hematology Drugs Approved in the United States: 2011-2017.


Stay strong