Advance care directives (ACDs) are instructions regarding what types of medical treatments a patient desires and/or who they would like to designate as a healthcare surrogate to make important healthcare decisions when the patient is mentally incapacitated. At end-of-life, when faced with poor prognosis for a meaningful health-related quality of life, most patients indicate their preference to abstain from aggressive, life-sustaining treatments. Patients whose wishes are left unsaid often receive burdensome life sustain therapy by default, prolonging patient suffering. The CoVID pandemic has strained our healthcare resources and raised the need for prioritization of life-sustaining therapy. This highlights the urgency of ACDs more than ever. Despite ACDs’ potential to provide patients with care that aligns with their values and preferences and reduce resource competition, there has been relatively little conversation regarding the overlap of ACDs and CoVID-19. There is low uptake among patients, lack of training for healthcare professionals, and inequitable adoption in vulnerable populations. However, solutions are forthcoming and may include electronic medical record completion, patient outreach efforts, healthcare worker programs to increase awareness of at-risk minority patients, and restructuring of incentives and reimbursement policies. This review carefully describes the above challenges and unique opportunities to address them in the CoVID-19 era. If solutions are leveraged appropriately, ACDs have the potential to address the described challenges and ethically resolve resource conflicts during the current crisis and beyond.

6519 Background: HRQoL data in cancer clinical trials can inform tolerability of new drugs, facilitate informed decision-making, and influence health care and policy decisions, but are frequently underreported. We reviewed all registration trials that informed Food and Drug Administration (FDA) approval between 2015-2020 for latency and quality of HRQoL reporting. Methods: HRQoL data for each clinical trial associated with FDA drug approval between 7/2015-5/2020 was collected retrospectively from multiple sources including the FDA and clinicaltrials.gov website, conference abstracts, and journal manuscripts. The aim of the study was to analyze the proportion of trials reporting HRQoL, quality of HRQoL data, latency between FDA approval and first reporting of HRQoL data, and association between changes in HRQOL and overall survival (OS) and progression-free survival (PFS) outcomes. Results: Of the 259 trials involving 245 drug approvals, majority involved solid tumors (61.4%), were phase III (59.1%), and led to approval based on a non-PFS/OS endpoint (52.9%). HRQoL was a pre-specified endpoint in 55.2% and reported in 49.8% trials. HRQoL data was published by the time of FDA approval in only 41.8% cases, 24.8% reported HRQoL data > 12 mo after approval. Further, among trials reporting HRQoL (n = 129), HRQoL data was first reported in the primary paper in only 34.1%, and either in an ancillary paper in 41.9% or an ancillary abstract in 24% trials. Of the 129 trials with HRQoL data, an improvement in HRQoL was seen in 44.2%, no significant change in 41.9%, mixed results in 11.6%, and worsening in 2.3% of trials. Overall, by the time of FDA approval, OS and PFS data were reported in 59% (152/259) and 65% (168/259) trials respectively with an OS benefit seen in 23.9% (62/259) trials, and PFS benefit in 38.6% (100/259) trials. Of the 84 trials that led to FDA approvals based solely on response rate, HRQoL was reported in only 23.8% (n = 24) with a HRQoL benefit seen in only 9.5% (n = 8) trials. Trials reporting either no significant impact on HRQoL or a mixed impact on HRQoL reported median OS benefit of 4.6 months and 4.2 months respectively. In trials reporting HRQoL data > 6 mo from FDA approval, OS benefit of < 3 mo was seen in 17.8% (8/45) trials. No significant time trends were noted during the study period. Conclusions: There was significant underreporting of HRQoL outcomes in trials ( < 50%) associated with FDA drug approvals between 2015-2020 with majority of trials reporting HRQoL data in an ancillary paper/abstract, and at a much later time than the FDA approval. While it is widely accepted that timely dissemination of HRQoL data from cancer drug trials are vital for clinical and regulatory decisions, no improvement in reporting rates were noted over past 5 years. Only 10% of drugs approved on the basis of response rates showed improvement in HRQoL in the registration trials.

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