Abstract
Background:
The digitalization of clinical research has increased reliance on electronic portals (e-portals), with significant implications for trial site operations. Our aim is to map the types and number of e-portals required for clinical trials on solid tumors conducted at the Niguarda Cancer Center.
Methods:
We performed an aggregated analysis of 65 interventional drug trials (phase I–III) initiated between August 2022 and March 2025. For each study, the number and type of e-portals required at the site were recorded and stratified by sponsor type. Analyses were conducted using R.
Results:
A total of 65 trials were included (57 industry-sponsored, 8 academic). The mean number of e-portals per study was 5.3, with 66.1% of trials requiring 5–7 portals. Industry-sponsored trials employed significantly more e-portals than academic ones (mean ± SD: 5.8 ± 1.7 vs. 1.13 ± 0.35; t(41)=22.10, p<0.0001). Electronic Data Capture (EDC) systems were universally implemented (100%). Additional portals for randomization (IXRS), central laboratories, imaging, and safety reporting were common in industry-sponsored trials but rarely used in academic studies. Patient-reported outcomes (PROs) were included in ~49% of industry and 88% of academic trials; 89% of PROs in industry studies were captured via ePRO portals, while academic trials mostly relied on paper forms or EDC integration.
Conclusions:
Industry-sponsored oncology trials impose a high digital workload on sites. Vendor streamlining, single sign-on solutions, open API standards, and shared ePRO infrastructures could improve efficiency, interoperability, and data quality.
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