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Standardize PROs, Says FDA Draft Guidance
In carpentry, it is best to measure twice and cut once. In cancer clinical trials, it is best to measure patient-reported outcomes uniformly, according to a new draft guidance from the FDA.
In carpentry, it is best to measure twice and cut once. In cancer clinical trials, it is best to measure patient-reported outcomes (PROs) uniformly, according to a new draft guidance from the FDA.
“Heterogeneity of PRO measurement has lessened the “regulatory utility” of PRO data, says the guidance, which was issued in June. The document recommended sticking to five core PROs: disease-related symptoms, symptomatic adverse events, overall side effect summary measures, physical function and role function. Disease-related symptoms include pain, anorexia and fatigue. Neuropathy is an example of a symptomatic adverse event.
The overall adverse event measure can help investigators assess the tolerability of a medication and adjusts for some patients emphasizing certain adverse events more than others, the guidance says. Measuring “role function” is assessing the effect a treatment has on a patient’s ability to work and carry out daily activities.
None of this is uncharted territory, and the guidance points to existing scales and instruments for measuring the core PROs. The guidance also has some suggestions for how often patients should be asked to supply PROs and mentions taking into account the “response burden to patients.” The guidance says baseline assessments should be done to establish a reference point for change and that assessments ought to be done more often during the first few treatment cycles.
Bridging the Diversity Gap in Rare Disease Clinical Trials with Harsha Rajasimha of IndoUSrare
November 8th 2023Briana Contreras, an editor with Managed Healthcare Executive, spoke with Harsha Rajasimha, MD, founder and executive chairman of IndoUSrare, in this month's episode of Tuning in to the C-Suite podcast. The conversation was about how the disparity in diversity and ethnicity in rare disease clinical trials in the U.S. has led to gaps in understanding diseases and conditions, jeopardizing universal health, and increasing the economic burden of healthcare.
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Study Raises Concerns Over Insurance Barriers to HIV Prevention Medications
November 29th 2023Despite its efficacy, PrEP remains underutilized compared to the need for it. High costs are among the barriers to PrEP use, along with limited knowledge among clinicians, lack of health insurance, stigma, and underestimation of personal HIV risk.
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Managing Editor of Managed Healthcare Executive, Peter Wehrwein, had a discussion with William Shrank, M.D., a venture partner with Andreessen Horowitz, a venture capital firm in Menlo Park, California, about how artificial intelligence's role is improving healthcare, where we are today with value-based care and the ongoing efforts of reducing waste in the healthcare space for this episode of the "What's on Your Mind" podcast series.
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