Abstract P4-20-01: Implications of financial modeling in breast cancer clinical research from 1990 to 2010

Abstract

Abstract SUMMARY: Over the past two decades significant progress has been made in breast cancer treatment resulting in a substantial improvement in patients' outcome. But we have to think about who promotes all this research and the consequences of the type of fundingThis project aims to evaluate the implication of finance in clinical research and the variance according to the type of funding. OBJETIVES: To evaluate the financial evolvement of breast cancer clinical trials in the past two decades, regarding the phase of development design of the studies, the collaboration between Academy (Acad) and Industry (Ind), the sample size, the study results and the statistical analyses conducted. METHODS: A systematic review was performed using MEDLINE to identify breast cancer randomized clinical trials published between January1990 and December2010. Studies that involved chemotherapy, endocrine and/or targeted therapies, wherethe primary endpoint was considered adequate to support a drug approval in oncology according to the FDA and EMA (U.S. Food and Drug Administration and European Medicines Agency, respectively), were included. RESULTS:Data were evaluated 2,211 and 472 met selection criteria comprised in the methodology During the first decade the Acad was the main breast cancer research promoter being replaced by the Inv. throughout the second decade (p <0.0001). Thirty nine percent of the studies evaluated were phase III (39% Acad, 61% Ind), 15% were phase II (30% Acad, 70% Ind) and the remaining 47% were not classified by authors (65% Acad 35% Ind). As for the primary endpoint, 25% of the phase III trials evaluated progression free survival, 15% overall response rate, 1% time to progression and only 5% examined overall survival. Sixty five percent of the trials were national (60% Acad 40% Ind) and 35% international (25% Acad 75% Ind). Single-center studies accounted for 11% of the trial (65% Acad 35% Ind). Most of the national trials were developed by the US. Fifty four percent of the studies were conducted by research groups (67% supported by Ind. and 33% Acad.). The Ind sponsored 26% of the studies in the first decade and 50% during the second. The median number of patients enrolled by research groups was 892 in contrast with 409 included by other organizations. The primary endpoint was achieved in 19% of the Acad trials and 21% of the Ind trials. Only 53% of the studies declared intention to treat based analysis in their statistical workout. RESULTS ACADEMY(%)INDUSTRY (%)PPROMOTION OF THE STUDY1990-2000121(26)68(14)0,0001 2001-2010105(22)178(38)0,0001STUDY DESIGNUNICENTRIC TRIALS34(7)18(4)0,007 MULTICENTRIC TRIALS191(40)228(48) NATIONAL TRIALS183(39)122(26)0,0001 INTERNATIONAL TRIALS42(9)124(26) COOPERATIVE GROUP95(20)160(34) NOT COOPERATIVE GROUP130(28)86(18) STATISTICAL ANALYSISINTENT OF TREAT86(18)163(35) NOT DECLARATED140(30)83(18) CONCLUSIONS:There is a significant tendency towards the promotion of research by the pharmaceutical industries during the last two decades, leading a change in the clinical trials design and the endpoints. Citation Format: Jerez Y, Lopez-Tarruella S, Marquez-Rodas I, Perez S, Ocaña A, Echavarria I, Lobo M, Gallego I, Torres G, Ortega L, Garcia G, Palomero I, Gonzalez Del Val R, Massarrah T, Esteban M, Del Monte-Millan M, Martin M. Implications of financial modeling in breast cancer clinical research from 1990 to 2010 [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P4-20-01.