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Are cancer drug trials accurately capturing side effect severity?

Cancer drugs can have some rather major side effects. A recent study indicates that the side effects of new cancer drugs may be even more severe than their clinical trials indicate, if such trials relied largely on doctor reports to track side effect severity. This is because the study found that doctor reports in clinical trials tend to under-report side effects as compared to the reports of the patients in such trials.

The study focused on 1,090 patients of three cancer drug clinical trials. The study looked at what the patients themselves reported having experienced in the way of side effects during the trials and compared it to what doctors in the trials reported regarding patient side effects. The study particularly looked at what was reported regarding six common side effects of chemotherapy drugs: hair loss, appetite loss, diarrhea, constipation, nausea and vomiting. The study found that for all six of these side effect classes, the doctors reported significantly lower occurrence rates than the patients did.

What do you think is behind this under-reporting of side effects by doctors that the study found? Do you think it has something to do with something getting lost in communications between patients and doctors?

A question this study raises is: should clinical trials incorporate more in the way of direct reports from patients when trying to track the side effects of a given drug?

What side effect severity clinical trials end up concluding a given cancer drug has can be very impactful, as it could potentially affect doctor and patient decisions. Thus, one hopes clinical trial researchers will do everything they can to ensure that side effect findings in clinical trials of new cancer drugs are as accurate as possible.

The fact that the side effects of cancer drugs/treatments can be quite severe is one of the many reasons why cancer can sometimes leave a person in a state where they can't work. Social Security disability benefits may be available for cancer sufferers that have had their functional abilities so heavily reduced by their condition and/or the treatment for it that they are no longer an active member of the workforce.    

Source: Reuters, "Clinical trials may under report side effects of cancer drugs," Shereen Lehman, Feb. 12, 2015

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