Sponsorship of oncology clinical trials in the United States according to age of eligibility
- The analysis focuses on the sponsorship of interventional oncology trials for patients under 18 in the U.S.
- There are fewer industry-sponsored trials for pediatric oncology compared to adult trials and other pediatric disciplines.
- Industry-sponsored trials tend to be phase III, enroll more patients, and complete faster.
- Legislation like the RACE for Children Act may boost industry involvement in pediatric oncology.
- Historical data indicates a rise in industry sponsorship for adult cancer trials, suggesting a potential increase for pediatric trials, especially with new molecularly targeted agents.
- Limitations of the study include the inability to distinguish between sponsors and funders and the lack of global data.
- Future research should focus on global trends and more detailed age-specific analyses.
- The study underscores the evolving landscape of pediatric oncology trial sponsorship and the need for ongoing evaluation as drug development and regulations change,
The sponsor of a clinical trial is the single entity responsible for the overall conduct and oversight of the trial. Sponsors play a critical role in the design and reporting of clinical trials, with most trials sponsored by the pharmaceutical industry, government agencies, or academic institutions. Trial sponsorship has been shown to be associated with a number of factors, including likelihood of completion and publication of trial results.
Prior studies have investigated the impact of clinical trial sponsorship on trial characteristics. These analyses suggest that elements of trial design, such as randomization, blinding, and use of data monitoring committees (DMCs), are influenced by sponsor type. For example, reported use of DMCs was less common in industry-sponsored vs NIH-sponsored trials, likely due to NIH mandates for DMCs for government-funded trials. Several studies have also suggested that trial outcomes are associated with sponsorship status. Industry-led trials are more likely to have positive trial outcomes compared to NIH or academic-led trials, with one analysis reporting that industry sponsorship was also associated with decreased reporting of results. There have been more recent studies investigating temporal trends in trial sponsorship within the United States. In an analysis of trials registered on ClinicalTrials.gov, one group reported a decrease in trials sponsored or funded by the NIH from 2006 to 2014...
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