Speaker
Description
Background:
Oncology trials remain the largest sector of global drug development. However, their complexity, resource demands, and modest success rates underscore the need for more efficient, patient-centred, and methodologically innovative designs.
Objective:
To provide a longitudinal assessment of interventional oncology trial characteristics and design trends from 2000 through 2025 using the Aggregate Analysis of ClinicalTrials.gov (AACT) database.
Methods:
Drug and biologic interventional oncology trials initiated between January 1, 2000, and September 30, 2025, were analysed using a static version of the AACT database. Key features including trial phase, design type, sponsor, primary endpoints, and cancer indication were summarised by initiation year and trial status.
Results:
Among 62,703 interventional oncology trials identified, most were single-arm (48%) and early phase (I–II, 78%), with non-industry sponsors (67%). The use of surrogate endpoints (e.g. PFS, ORR) rose more than four-fold from 2000 to 2024, while adoption of master protocols and adaptive designs increased modestly in the past decade. Completed trials showed shorter enrolment periods and durations over time, and result reporting improved, though timely disclosure (≤ 12 months) remained uncommon. Ongoing trials most frequently studied gastric, breast, leukaemia, non–small cell lung cancer, and non-Hodgkin lymphoma malignancies.
Conclusions:
Oncology clinical trial activity expanded substantially over the past 25 years, with incremental adoption of innovative designs and surrogate endpoints. Despite improved reporting, timeliness and integration of patient-reported outcomes remain limited. These findings highlight ongoing gaps between methodological advancement and implementation, reinforcing the need for a more efficient, transparent, and patient-focused oncology trial enterprise.
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