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Clinical Trials Fail to Properly Report Quality of Life Assessments

Jan 17, 2020

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A meta-analysis done on all phase 3 clinical trials for advanced or metastatic cancer found that there were over 125,000 patients enrolled in studies that did not assess quality of life outcomes. The correlation between the reported endpoint of progression free survival, a measure of time that the cancer has not progressed, and improved quality of life, was low. This analysis indicates that the surrogate endpoints reported in clinical trials are not a good measure for the important metric of quality of life assessments for the patients.

Even if one is clearly diagnosed with cancer, the patient and his or her family will not immediately jump to starting chemotherapy the next day because they usually need to fully evaluate all their options first. And an important part of that is seeing how a potential therapy is going to affect a person’s quality of life. Agreeing to begin and endure the chemotherapy process is a huge decision, primarily for elderly patients, because they have to decide how many physical hardships they would be willing to endure in order to become cancer free. If the side effects of a certain drug are so drastic that it renders a person lifeless anyways, keeping in mind that no therapy is for sure in terms of recovery, would it be worthwhile for a patient to put him or herself through that?

Quality of Life Assessment Reporting in Clinical Trials

The bottom line is that the patients and their families should be making these life changing decisions themselves and fully informed of what enduring a certain therapy would entail. However, clinical trials often fail to properly report how a certain drug will affect the quality of life of patients, which is vital information for potential drug users.

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Quality of Life Assessment

In 2018, there was a study done by researchers from Harvard Medical School in Boston on the association between a cancer patient’s progression free survival and their quality of life. Essentially, the ideal standard for measuring the efficacy of a clinical trial would be measuring the overall survival (OS) rate but that would take too long to obtain results for, so there are other endpoints used instead such as the progression free survival rate (PFS). The PFS measures the rate of patients who have survived without the tumor progressing any further. However, an increasing number of clinical trials on potential chemo drugs are using the PFS as a substitute for data on the quality of life (QoL) of patients as well. Out of all the phase 3 clinical trials for advanced or metastatic cancers which the researchers reviewed, “A total of 125,962 patients were enrolled in studies lacking or not reporting quality of life outcomes. Among trials that did report quality of life outcomes, 67% reported no effect, 26% reported a positive effect and 7% reported a negative effect of treatment on patients’ global quality of life. Importantly, the correlation between PFS and improved quality of life was low, with a correlation coefficient and AUC value of 0.34 and 0.72, respectively” (Hwang T J and Gyawali B, Int J Cancer. 2019).

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What this study clearly shows is that other surrogates are not a good measure for quality of life assessments of clinical trials. Information should be separately delivered on how a drug can affect the quality of life of a patient because unlike being a straight statistic like the months of PFS with a drug, quality of life information is necessary for both patients and physicians to make informed decisions about their future.

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Scientifically Reviewed by: Dr. Cogle

Christopher R. Cogle, M.D. is a tenured professor at the University of Florida, Chief Medical Officer of Florida Medicaid, and Director of the Florida Health Policy Leadership Academy at the Bob Graham Center for Public Service.

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