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Patient Reported Outcomes Left Off Cancer Drug Labels

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Shalini Shah1 year ago

Prescription drugs in the U.S come with information called package insert, which details how the medicine works, how it should be used, data from clinical trials, and sometimes patient reported outcome.

However, a recent study found that details regarding the benefits and disadvantages patients experienced when taking cancer drugs is rarely included on the product label. This valuable information could provide doctors and patients more knowledge about which treatment choices to make.

About the Lack of Patient Reported Information

Reuters reports including patient reported information about cancer drugs would help physicians and patients who are trying to make decisions about quality of life, not just quantity of life.

A study was conducted to see whether new cancer drugs come with patient reported information on their package inserts, which are approved by the U.S Food and Drug Administration (FDA).

The study analyzed labels of all cancer medications released in the U.S between January 2010 and December 2014. Over this five-year study span, 160 new drugs were approved by the FDA, 40 of them were cancer drugs.

Among the cancer drugs, only 3 or 7.5% of them included reports of patient experiences. The study team in comparison showed that the FDA review of new medications of all types approved between 2006 and 2010 found that 24% of them had patient reported outcome information.

Studies on 13 of the cancer drugs looked at patient reports during the study process, but did not include the results on the package label.

Implications of the Study

Researchers found that cancer drugs, compared to others, were more likely to be orphan drugs, which were developed for rare medical conditions. These drugs were more likely to be the first of their kind in a new class of medications.

This makes it even more critical for doctors and patients to understand how these drugs can potentially affect patients.  

The FDA does encourage the inclusion of patient experience reports in the package insert information of these drugs, but other rules make it difficult to do so.

One obstacle is that most cancer drug trials that are conducted are small. This implies that doctors and patients know who is receiving the drug, so there is a possibility of some bias in the results.

Secondly, a majority of cancer drug reviews by the FDA were fast-tracked, meaning the drugs went through a faster approval process to help fill the treatment gaps in medical care. However, this doesn’t leave enough time to gather and analyze patient experiences.


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