Abstract P4-18-02: Relationship between type of therapeutic intervention and funding source in randomized clinical trials (RCTs) in breast cancer

Abstract

Abstract Background: Pharmaceutical companies play an important role in new drug development and approval in an environment where performing RCTs has become increasingly costly and complex. However, myriad questions about the impact of clinical, surgical and radiotherapy interventions equally require adequate hypothesis testing in RCTs. A potential lack of funding for RCTs not directly related to new drug development might lead to important gaps in clinical knowledge. Methods: We searched PubMed for all RCTs published between 01/2009 and 12/2013 in breast cancer. All articles published in this period were manually screened for eligibility. We included only RCTs with clinical endpoints such as TTP, PFS, OS and response rate. Two investigators independently selected phase 2 and phase 3 RCTs with at least 50 patients published in English. We also searched National Cancer Institute (NCI) data for all active, therapeutic phase 3 trials that are currently enrolling patients (as of 05/05/2014). We classified eligible trials according to the type of intervention (drugs, radiotherapy or surgery) and the stated funding source (industry versus nonprofit). Results: We retrieved 1,676 PubMed studies of which 247 (15%) were eligible. 218 (88%) of the RCTs evaluated drugs, 14 (6%) radiotherapy and 15 (6%) surgery. 183/247 (74%) RCTs were funded entirely or partially by industry (pharmaceutical and device companies) and 64/247 (26%) by nonprofit organizations (government, academic centers or foundations). There was a significant association between source of funding and type of intervention: 183/218 RCTs (83%) evaluating drugs were funded by industry, in comparison to none of surgical and radiotherapy RCTs (P<0.0001). From the NCI data we retrieved 144 RCTs. 116 (81%) of the RCTs studies drugs, 20 (14%) radiotherapy and 7 (5%) surgery. 55/116 (47%) trials evaluating drugs were funded by industry in comparison to none of surgical and radiotherapy trials. Eighty eight trials were not funded by industry. Of those, 23(26%) were performed in China, 16(18%) in the USA, 10 (11%) in France, 7 (8%) in India, 6 (7%) in the UK and the remaining 26 studies were performed in 16 other countries Conclusions: The vast majority of RCTs in oncology relates to drug development and is being funded by industry, while 100% of RCTs evaluating surgical or radiotherapy related questions are not industry funded. This scenario seems not be changing over the last years given that the comparison between published trials and active trials shows the same scenario. Even though new drug development is of paramount importance, the extent to which clinically relevant issues are not being properly addressed by RCTs, at least in part due to lack of funding, should be considered and further evaluated. The oncologic community, as well as academic and nonprofit organizations, including governments, need to work together to forge new and alternative forms of research funding in order to allow us to answer critical clinical questions that we, as oncologists, face in our daily practice. Citation Format: Artur Katz, Fernando Santini, Fabio Y Moraes, Andrea K Shimada, Caroline Chaul, Manuel C Abraao, Everardo D Saad. Relationship between type of therapeutic intervention and funding source in randomized clinical trials (RCTs) in breast cancer [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P4-18-02.