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Parenteral and enteral nutrition support are key components of care for various medical and physiological conditions in infants, children, and adults. Nutrition support practices have advanced over time, driven by the goals of safe and sufficient delivery of needed nutrients and improved patient outcomes. These advances have been, and continue to be, dependent on research and development studies. Such studies address aspects of enteral and parenteral nutrition support: formulations, delivery devices, health outcomes, cost-effectiveness, and related metabolism. The studies are supported by public funding from the government and by private funding from foundations and from the nutrition support industry. To build public trust in nutrition support research findings, it is important to underscore ethical research conduct and reporting of results for all studies, including those with industry sponsors. In 2019, American Society for Parenteral and Enteral Nutrition's (ASPEN's) Board of Directors established a task force to ensure integrity in nutrition support research that is done as collaborative partnerships between the public (government and individuals) and private groups (foundations, academia, and industry). In this ASPEN Position Paper, the Task Force presents principles of ethical research to guide administrators, researchers, and funders. The Task Force identifies ways to curtail bias and to minimize actual or perceived conflict of interests, as related to funding sources and research conduct. Notably, this paper includes a Position Statement to describe the Task Force's guidance on Public-Private Partnerships for research and funding. This paper has been approved by the ASPEN Board of Directors.

Background and objectives This study was conducted to compare the safety and efficacy of intravenous epoetin alfa-epbx, an epoetin alfa biosimilar, to epoetin alfa in patients on hemodialysis with ESKD and anemia. Design, setting, participants, & measurements In this 24-week, multicenter, double-blind comparative efficacy and safety study, 612 patients on hemodialysis with ESKD and anemia who had stable hemoglobin and were receiving stable doses of intravenous epoetin alfa were randomized (1:1) to intravenous epoetin alfa or epoetin alfa-epbx. Dosing was adjusted according to the epoetin alfa prescribing information. The coprimary efficacy end points were the least squares mean difference between the two treatments in mean weekly hemoglobin level and mean weekly epoetin dose per kilogram of body weight during the last 4 weeks of treatment. Results The least squares mean difference between epoetin alfa-epbx and epoetin alfa in weekly hemoglobin was −0.12 g/dl and the 95% confidence interval (−0.25 to 0.01) was contained within the prespecified equivalence margin (−0.5 to 0.5 g/dl). The least squares mean difference between epoetin alfa-epbx and epoetin alfa in weekly epoetin dose per kilogram of body weight was 0.37 U/kg per week, and the 95% confidence interval (−10.40 to 11.13) was contained within the prespecified equivalence margin (−45 to 45 U/kg per week). Incidences of adverse events (77.1% versus 75.3%), serious adverse events (24.9% versus 27.0%), and deaths (n=5 versus 6) were similar between the epoetin alfa-epbx and epoetin alfa groups, respectively. Five patients tested positive for anti-recombinant human erythropoietin antibodies at baseline, and two additional patients (n=1 per group) developed anti-recombinant human erythropoietin antibodies while on study treatment. All patients tested negative for neutralizing antibodies, and no patient in either group experienced an event of pure red cell aplasia. Conclusions This 24-week, comparative, clinical trial in patients on hemodialysis with ESKD and anemia demonstrated there is no clinically meaningful difference in efficacy or safety between epoetin alfa-epbx and epoetin alfa.

Purpose The purpose of this study was to evaluate the pharmacodynamic (PD) and pharmacokinetic (PK) equivalences of multiple doses of the proposed biosimilar Epoetin Hospira to the reference product Epogen ⁎ ⁎Epogen ® (epoetin alfa; Amgen, Thousand Oaks, California)., when each is administered three times per week over 28 days to healthy male subjects Methods This single center, open-label, randomized, parallel group study was conducted in 129 healthy male subjects. Subjects were randomized to receive 100 U/kg Epoetin Hospira or 100 U/kg Epogen, each administered subcutaneously 3 times per week over 28 days. Blood was collected for determination of hemoglobin (Hb) concentrations for PD properties and for determination of epoetin concentrations for PK properties. The primary PD end point was the geometric mean ratio (GMR) of the 2 treatments for area under the effect curve for Hb from day 1 through 48 hours after the final dose of study drug administration on day 26, and the primary PK end point was the GMR of the 2 treatments for AUC 0–48 and C max for epoetin after the final dose of study drug on day 26. Findings The GMR (Epoetin Hospira/Epogen) for the area under the effect curve for Hb from day 1 through 48 hours after the final dose of study drug administration on day 26 was 1.006 with a 95% CI of 0.996 to 1.016, which was contained within the prespecified equivalence margin of 0.965 to 1.035. The GMRs (Epoetin Hospira/Epogen) for the epoetin-derived PK parameters were 0.974 for AUC 0–48 with a 90% CI of 0.896 to 1.059, and 0.938 for C max with a 90% CI of 0.839 to 1.049, with both 90% CIs contained within the prespecified equivalence margin of 0.80 to 1.25. The incidence (21.2% and 23.8% for Epoetin Hospira and Epogen, respectively) and severity of adverse events were similar between the 2 groups. One subject in each treatment group had a positive recombinant human erythropoietin antibody result by radioimmunoprecipitation assay before dosing and throughout study conduct with negative immunoglobulin M and neutralizing antibodies and with no evidence of clinical deterioration or of impact on PD, PK, or safety profile. Implications The results of this study established PD and PK equivalences of multiple subcutaneous doses of the proposed biosimilar Epoetin Hospira to the reference product Epogen in healthy male subjects, and supported the overall demonstration of biosimilarity of Epoetin Hospira and Epogen.

PURPOSE: To determine the effect of highly active antiretroviral therapy on cytomegalovirus (CMV) retinitis treated with ganciclovir implants. METHODS: A retrospective cohort study was performed of 15 patients with recurrent CMV retinitis treated with the ganciclovir implant and highly active antiretroviral therapy (cases) and 38 patients with recurrent retinitis treated with ganciclovir implants before availability of improved antiretroviral therapy (controls). Progression was defined as occurrence of new lesions in the treated eye or advancement of the retinitis border by more than 750 μm. RESULTS: Cases and controls were statistically similar in age, ethnicity, and duration of acquired immunodeficiency syndrome (AIDS). Controls had received intravenous ganciclovir for 9.5 ± 9.5 months vs 3.5 ± 4.6 months in cases ( P = .003). The mean (± SE) time to progression of retinitis after implantation of the device was 26.7 ± 2.4 months (95% confidence interval, 22.1 to 31.3) in the cases receiving highly active antiretroviral therapy vs 6.2 ± 0.9 months (95% confidence interval, 4.5 to 7.9) in the controls ( P = .001). Multivariate analysis, adjusted for preoperative variables, confirmed a significantly prolonged time to progression in patients receiving highly active antiretroviral therapy ( P = .0003). The odds ratio for progression in the cases vs controls was 0.034 (95% confidence interval, 0.003 to 0.350). Cases had higher CD4 + T-lymphocyte counts ( P = .004) and longer survival ( P CONCLUSION: Highly active antiretroviral therapy is associated with improved outcomes in patients with AIDS and recurrent CMV retinitis treated with the ganciclovir implant.