Authors:
Stefano Stabile, Sara Mariano, […], and Salvatore Siena +8 (View all authors)
Abstract
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.
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.
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.
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.
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.
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.
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.