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Researchers Develop New Standards For Quality Of Life Measurement In Cancer

(EORTC) Jan 31, 2020 - For the first time, recommendations for the analysis of patient-reported outcomes (PROs) in cancer clinical trials have been developed by an international group of experts. The recommendations will help to determine more consistent and comparable Quality of Life (QoL) results from clinical trials.

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William McGivney, PhD (Posted: February 06, 2020)

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Almost all of us will be patients with a serious illness at some point in our lives. As such, how we feel, how we can function, how we view our survival and mortality, etc. are among the critical components of a quality life. My last sentence demonstrates the overlap of concepts (e.g., QOL and PROs) and sometimes the confusion behind what is being measured on top of the collection of safety and efficacy data. Clearly, the move by EORTC to attempt to “standardize the analysis of PROs in RCTs” will help. Quite frankly, I am not sure what the statement in quotes means exactly, but I do not prioritize the issue highly enough to pull more time away from my other efforts.
Notwithstanding that, I do know that in the United States the application of the results of formal PRO assessments, long- and much- talked about, achieve only minor attention in policy-setting and in clinical decision-making. I remember about 5 years ago, being on a public Panel and being asked the first question. With significant timidity, I gave the answer per the above sentence. I thought that the patient advocates, one biopharma rep, and the one government policy person on the Panel would shower me with disdain. Interestingly, I had broken the ice and spoken the truth. My colleagues on the Panel actually responded in general agreement with me. I had made it okay to come out from behind the curtain of political correctness that we see so often on such Panels.
PROs are important. But where do they fall in the cascade of issues and wants of the patient? To my mind, patients always see themselves in the upper decile for survival. Patients certainly want to understand the probabilities and degree of pain and discomfort certain Adverse Effects of selected drugs/biologics and other treatments can bestow. As above, the identification of and definition of such outcomes and others (QOL and its component parts) are all relevant. But to date, regulators, payers/MCOs and clinicians in the US generally focus on traditional explanations of risk/benefit in terms of safety and efficacy in their policy setting and decision-making. A 2019 study (Toumi et al, Recent Results Cancer Research) supports this statement.
The allotment of valuable and limited resources such as time and money requires the hierarchical prioritization of which outcomes to evaluate in a rigorous, scientific manner.
The effort in Europe to achieve more directive, clarifying standardization for PROs is important. It will be interesting to review again in 5-10 years to see where we are with the assessments and application of PROs in decision-making in the US.

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