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clinical trials industry oncology pediatric sponsorship

Sponsorship of oncology clinical trials in the United States according to age of eligibility


Summary

  • The sponsorship mix of trials relevant to young people with cancer has not been well-documented, which may impact policies and regulations in pediatric cancer drug development.
  • An analysis of interventional trials in the U.S. from 2007 to 2018 was conducted using the ClinicalTrials.gov registry, focusing on age of eligibility and sponsorship type (industry vs non-industry).
  • For oncology trials involving patients ≥18 years, 33% were industry-sponsored, while 67% were non-industry-sponsored. For trials including patients <18 years, 16.6% were industry-sponsored, and 83.4% were non-industry-sponsored (P < .001).
  • Only 5.2% of industry-sponsored oncology trials included patients <18 years, compared to 15.5% in non-oncology disciplines (P < .001).
  • There has been a statistically significant increase in industry sponsorship of oncology trials including patients <18 years over time (P < .001).
  • Trial characteristics vary significantly depending on the type of sponsor, regardless of the age of eligibility.
  • Interventional oncology trials for patients <18 years are less likely to be industry-sponsored compared to those for patients ≥18 years, and industry-sponsored trials tend to have different characteristics, such as duration and enrollment numbers.

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.

Data on sponsorship of pediatric clinical trials are sparse. In one analysis, 6.7% of trials either sponsored or funded by the NIH were exclusively focused on pediatric populations, with another 7% of trials open to adults and children. In another analysis of pediatric interventional clinical trials across disciplines, 32.3% were industry‐sponsored, 7.8% were government‐sponsored, and 59.9% were sponsored by academic institutions or other organizations. Little work has investigated sponsorship status specifically in trials relevant to children with cancer. In this context, we sought to examine the distribution of sponsor types for oncology trials relevant to young people. We compared trial sponsorship according to age of eligibility for oncology trials and for trials in other disciplines. We examined whether sponsorship is associated with differences in trial characteristics (eg phase, duration, enrollment). Understanding the current landscape of sponsorship of trials relevant to young people with cancer may have important implications for advocacy and policy efforts to accelerate cancer drug development for this population.

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clinical trials, industry, oncology, pediatric, sponsorship