Evaluating the comparative effectiveness of clinical trial participation on hospital outcomes among cancer patients: A trend analysis.

e23178Background: Research, therapy, strategy, and technological progress depend on participation in trials. Numerous randomized controlled trials encounter difficulties in achieving their sample size objectives within the designated timeframe. In these cases, it remains uncertain if outcomes such as the burden of illness (BOI) and clinical outcomes—healthcare-associated complications (HACs, including infectious complications and septicemias)—differed among cancer patients enrolled in clinical trials throughout their hospitalizations. Methods: Our objective was to examine the effects of involvement in clinical trials on patients with solid cancers or lymphomas. This research employed the 2016-2021 United States National Inpatient Sample (NIS) database. The exposure involved clinical trials participation (CTP), whereas the primary outcomes encompassed in-hospital mortality, healthcare-associated complications such as septicemias (HACs), length of hospital stays (LOS), and total hospital expenses. Propensity score (PS)--Weighting, matching, and stratification--were computed, and the PS score were adjusted in the multivariable regression analysis, and further estimated time points of significant change in outcomes through Joinpoint regression in R. Results: We examined (2019) 354, 760 lymphoma patients among them there were 3960 clinical trial participants. In the matched outcomes in 2019, (792 patients), the mortality and HAC were lower among clinical trial participants, but not the cost of care and LOS. In the PS-adjusted analysis, lymphoma patients enrolled in CTP was associated with lower HAC including infectious disease and septicemia (aOR:0.64, 95%CI:0.49-0.81), and mortality (aOR:0.56, 95%CI: 0.42-0.76), and further, CTP was associated with higher LOS (Coeff:1.36; 95% CI:1.23–1.51), and higher cost (Coeff:1.13; 95% CI:1.12–1.14), Furthermore, when compared to Whites, Blacks were associated with lower cost (Coeff: 0.64, 95%CI: 0.48-0.86), and compared to 75-100th percentile neighborhoods, 25-50th percentile (Coeff: 0.76, 95%CI: 0.58-0.99), and 50-75th percentile (95%CI: 0.59-0.98) lower cost. We further examined 1, 045, 335 metastatic cancer patients among them there were 5569 CTPs, and matched outcomes (1142 patients) were comparable to the lymphomas. Joint point analysis of the healthcare associated complications; mortality model projection remained steady from 2016-2021. Conclusions: This study revealed an overall steady trend in the incidence of healthcare associated complications, mortality, between 2016 and 2021. Given the HHS action plan aimed at decreasing health disparities based on race and ethnicity the shifting demographics of the United States, it is imperative that CTP to evaluate the effectiveness of emerging new modalities of treatments, and continually monitor the patient outcomes.