The Impact of Financial Support on the Development of Clinical Research in Multiple Myeloma: An in-Depth Analysis (1980-2024)

Introduction:

The incidence of multiple myeloma (MM) in the US has increased by over 40% since 1990. However, the 5-year survival rate has more than doubled in the past decade, largely attributed to significant advances in clinical research. Funding is a pivotal driver of these medical advancements. Presently, there is a dearth of comprehensive analyses on the origins and impact of funding in MM research. As such, the primary aim of this study is to identify the primary funding source of MM clinical trials, analyze funding trends over time.

Method:

We searched all registered interventional clinical trials on ClinicalTrials.gov in the United States from January 1980 to February 2024. Initially, we started with a total of 1,696 clinical trials related to MM. After excluding trials that involved cancers other than MM, observational studies, and phase 4 clinical trials, our query resulted in 1186 clinical trials. We categorized the included trials into five groups based on their sponsorship sources: industry-sponsored, academic institution-sponsored, National Institutes of Health (NIH)-sponsored, mixed funding (industry and NIH or academic institutions), and network-sponsored (including community-based organizations). The chi-square test was used to compare the total number of trials between groups over time.

Result:

Our analysis reveals trials were categorized: 480 (40%) trials were funded by industry,442 (37%) trials by academic institutions, 148 (12%) trials by NIH, 85 (7%) trials mixed funding, and 30 (3%) trials by network funding. Trials studying MM were reached between 2017-2020 with 230 (13.5%) trials, industry-sponsored being in the lead 122 (53%). The data indicates that phase 2 trials were the most common, accounting for 505 (42%) trials, with non-industry sponsorship for 247 (49%) p-value 0.0001. In contrast, phase 3 trials were the least frequent, comprising only 125 (11%) trials, with industry sponsoring 77 (62%) trials p-value 0.0001

The trials conducted between 1993 and 2024 included a total of 109,487 patients. Out of these, 71,496 (65%) were industry-sponsored, 20,113 (18%) academic-sponsored, 8,481 (8%) were part of NIH-sponsored trials, 8,186 (7%) were enrolled through network funding, and 4,143 (4%) were part of Mixed funding. The largest patient enrollment, 25,422 (23%), occurred between 2021 and 2024. Since 2001, the industrial sector has consistently led patient enrollment, while network funding has increased enrollment since 2013.

Upon analysis of the trial statuses, it was determined that 560 trials (47%) have been successfully completed, 180 trials (15%) are actively recruiting, 206 trials (17%) have been terminated, and 172 trials (15%) are active but not recruiting. Notably, the primary reason for termination was adverse events, and no significant correlation (p-value=0.44) was found between the type of funding and the likelihood of termination. It is noteworthy that a majority of approximately 40% of completed studies were industrial sponsored (p-value= 0.0068), with 38% of these trials in phase 1 and 29% phase 2; notably, 77% of phase 1 trials were completed between 2005 - 2016. Regarding academic sponsored trials 37% of completed trials were of this category, with phase 2 comprising 52%.

Conclusion:

Industry sponsorship serves as a prominent funding source for MM clinical trials. This discernible trend can be attributed to the pharmaceutical industry’s dominance in the production and progression of treatments, both of which are of paramount importance for managing and improving MM treatment outcomes