A retrospective look: Industry partnership and transparency in phase III randomized clinical trials of breast cancer targeted therapies across two decades.

Abstract

580 Background: To unveil industry involvement with respect to sponsorship, authorship, and demographic shifts in the trends of randomized clinical trials for breast cancer targeted therapies over the past two decades. Methods: All randomized phase III clinical trials focusing on targeted therapies for breast cancer were systematically identified from clinicaltrials.gov and reviewed using peer-reviewed publications. Trials that focused solely on chemotherapy and hormonal therapy were excluded. SAS Enterprise Guide v7.1 was used to analyze trial characteristics, authorship, and demographic details with Chi-square and Fisher’s exact tests. Results: From 2005-2023, 998 breast cancer treatment clinical trials were identified; 110 trials were included in the final analysis. Overall, 8.2% were limited to the U.S. and Canada while 67.3% were carried out internationally. 34.5% were led by cooperative (Co-op) groups vs 65.5% by pharmaceutical industries. 19.1% of trials were published in the New England Journal of Medicine (NEJM); all NEJM published trials reported positive results and 76.2% of were industry led. In contrast, of the 4.5% of trials featured in The Lancet, only 60% showed positive findings and 60% had major industry sponsorship. The most common industry partnerships were with Roche (27.3%), Novartis (12.7%), and Pfizer (7.3%) while the most common leading Co-op group was the National Cancer Institute (7.3%). To evaluate trends, trials were split into 3 time periods based on publication dates: 2005-2011, 2012-2017, and 2018-2023. The number of trial publications increased from 13 to 43 to 54. Of the 70% of trials that reported race/ethnicity data, the proportion of White patients decreased (84.5%, 78.8%, 79.3%; p<0.001) and the proportion of Asian patients increased (8.9%, 18.4%, 16.7%; p<0.001). However, enrollment of Black (6.6%, 2.8%, 4.0%; p<0.001) and Hispanic (7.0%, 2.8%, 5.0%; p<0.001) patients remained low. There were no statistically significant changes in international participation (46.2%, 69.8%, 70.4%; p=0.22), the proportion of exclusively industry-led (46.2%, 74.4%, 63.0%; p=0.15) or Co-op group-designed trials (61.5%, 35.7%, 26.4%; p=0.10). Industry-involved data collection increased from 23.1% to 64.2% to 73.6% (p=0.01) while industry sponsored data analysis (38.5%, 61.9%, 66.0%; p=0.49) and manuscript drafting (38.5%, 66.7%, 71.7%; p=0.09) did not significantly change. Conclusions: Over time, there was a notable rise in the number of phase III clinical trials for breast cancer targeted therapies. More than 70% of these trials now engage in international collaboration. Despite this progress, there remains an underrepresentation of Black and Hispanic participants in trial enrollment. Today, nearly 70% of trials have major industry sponsorship in study design, data analysis, and manuscript preparation.