12125 Background: This pilot study describes the cancer-specific social risk factors (SRFs) of oncology patients on active treatment and the acceptability of using SRF screening to inform care and bolster support during cancer treatment. Methods: This is an ongoing cross-sectional survey of adult cancer patients on active treatment at two outpatient cancer centers in the University of Pennsylvania Health System. Since October 2019, 176 patients have completed our two-part, 19-item social risk screening tool (44% response rate; 49% age > 65yo; 45% female; 35% non-white). Survey questions were adapted from other social screening measures (e.g., AHC-HRSN tool, PRAPARE), then pre-tested and modified for our cancer-specific population. Part 1 of our tool covers 12 SRFs in four core domains: technology (e.g., internet accessibility challenges), environmental (e.g., housing instability), emotional (e.g., social isolation), and financial (e.g., ongoing financial toxicity). In part 2, seven acceptability questions cover patients’ perceived appropriateness of and comfort with screening, expectations of clinical staff to act on identified SRFs, prior SRF assistance received, interest in receiving SRF assistance (i.e., a proxy for patients’ most pressing unmet social needs), willingness to add SRF data to electronic health records (EHR), and comfort sharing findings with other clinicians (e.g., oncologists, primary care physicians, nurses). Results: We identified an average of 2.48 SRFs per patient. The five most commonly reported SRFs were ongoing financial toxicity (57%), internet accessibility challenges (46%), social isolation (40%), housing instability (34%), and insufficient internet for telemedicine (29%). The majority of patients thought that SRF screening was appropriate (56%) and many felt comfortable being screened (63%). Half of patients expected cancer center staff to connect them to social resources (50%), fewer wanted staff to just be aware of their SRFs (43%), and a minority did not want staff to know about their SRFs (7%). Many patients had received prior SRF assistance (49%) or were interested in receiving future help (51%). Most patients felt discomfort toward listing SRF results in their EHR (63%) and some felt uncomfortable giving other clinicians access to this data (38%). Conclusions: Our study shows that oncology patients contend with SRFs while undergoing treatment and find SRF screening acceptable. These findings support clinical implementation of a cancer-specific social screening tool into routine cancer care, but also bring attention to privacy preferences and limited acceptability of EHR documentation of SRFs. Cancer centers adopting this approach may gain insights into where interventions or resources could be targeted to meaningfully address SRFs, potentially improving clinical outcomes for vulnerable populations.
Abstract Background The US Food and Drug Administration (FDA) plays a critical role in bolstering public confidence in vaccines and the vaccine review process. An important tool for enhancing transparency and public trust is the FDA’s Vaccine and Biological Related Products Advisory Committee (VRBPAC), a group of external experts that advises on scientific issues related to the licensure of vaccines. Objective To analyze key features of VRBPAC meetings convened over 20 years; estimate the probability of advisory committee review of newly approved vaccines, focusing on vaccines targeting emerging diseases; and examine the speed of and variance in approval times as a function of VRBPAC review. Methods Cross-sectional study of VRBPAC meetings convened and new vaccine licensure applications approved between January 1, 2000, and December 31, 2019. We analyzed the frequency of VRBPAC meetings and sessions; the percentage of newly licensed vaccines reviewed by VRBPAC; and the number of days between the submission of the licensure application and the date of FDA approval. Results Between 2000 and 2019, VRBPAC convened for a mean of 4.1 sessions per year. One-quarter of sessions was devoted to the review of specific vaccine products. During the same period, 44 new vaccine licensures were approved, 20% of which were for vaccines targeting emerging diseases. Almost half (48%) of successful new vaccine applications were reviewed by VRBPAC (n=21), a rate lower than for therapeutic applications. Among new applications targeting emerging diseases, 29% of non-influenza vaccines were reviewed by VRBPAC. There was no difference in the median time to approval as a function of VRBPAC review (364 days with VRBAC review vs. 365 days with no review, p=0.870). Conclusion The FDA has convened VRBPAC for reviews of about half of its vaccine products, less frequently for vaccines against non-influenza emerging diseases. There is considerable scope for the FDA to increase VRBPAC engagement in the vaccine review process.
