Impact of broadening trial eligibility criteria on the inclusion of patients infected with HIV in cancer clinical trials.

Abstract

1548 Background: In October 2017, an ASCO, Friends of Cancer Research (FoCR), and US FDA (ASCO/FoCR/FDA) task force recommended that common eligibility criteria be modified to make trials more inclusive. We examined whether patterns of HIV-related eligibility criteria changed over time in relation to these recommendations. Methods: Trial eligibility criteria were abstracted from ClinicalTrials.gov for any phase, US-based clinical treatment trials for patients with cancer from 2010-2024. Trials were classified as not excluding, conditionally excluding (ie, excluding under specific circumstances such as unstable or untreated cases), or completely excluding patients with HIV. Eligibility criteria were classified using OpenAI language models with prompt refinement and independent validation. Interrupted time series analyses were used to determine whether the recommendations in 2017 were associated with changes in HIV criteria. We also examined whether eligibility-criteria changes varied by phase and lead sponsor (federal vs. industry). Results: We evaluated 20,751 trials, mostly phase I-II (80.3%), with 7.8% federally and 40.6% industry funded, including breast (19.1%), lung (11.0%), prostate (16.2%), and colorectal (14.1%) cancers. The AI classification achieved 97% accuracy on the development sample and 94% on an independent validation sample. Overall, patients with HIV were wholly excluded in 28.9%, conditionally excluded in 26.1%, and not excluded in 45.0% of trials. The guidance was associated with an increase in conditional exclusion (13.1% to 29.1%; p<.001) and no exclusion (24.1% to 28.9%; p=.002), and a decrease in wholly exclusion (62.8% to 42.0%; p<.001). Similar shift patterns were observed across trials with different main funding sources (federal vs industry) and phases (I–II vs III) (Table). Conclusions: Following the ASCO/FoCR/FDA task force recommendations, HIV exclusion criteria shifted predominantly from complete exclusion to conditional exclusion, indicating progress toward more inclusive clinical trial designs. Acknowledgement: We thank Dr. Roy Burstein, PhD, at the Institute for Disease Modeling, Gates Foundation, for his invaluable advice. HIV exclusion criteria before and after the guidance. Nov 2017- Dec 2025 Jan 2010-Oct 2017, No. (%) Without guidance (%) With guidance (% ) p All C 4175 (48.1) 62.8 42.0 <.001 Cond 1905 (22.0) 13.1 29.1 <.001 N 2597 (30.0) 24.1 28.9 <.001 Federal led C 342 (41.5) 41.4 22.3 <.001 Cond 299 (36.2) 36.2 57.2 <.001 N 184 (22.3) 22.3 20.5 0.40 Industry led C 1589 (48.7) 61.1 40.2 <.001 Cond 532 (16.3) 12.6 25.5 <.001 N 1141 (34.9) 26.3 32.6 <.001 Phase 1-2 C 3742 (53.8) 69.3 46.6 <.001 Cond 1622 (23.4) 13.4 30.1 <.001 N 1581 (22.8) 17.3 22.5 <.001 Phase 3 C 958 (46.3) 52.0 29.1 <.001 Cond 442 (21.4) 10.2 26.2 <.001 N 666 (32.2) 37.8 44.7 0.10 C/Cond/N: completely/conditionally/not excluded.