(269) Integration of Basket/Umbrella Real-world Observational Studies (BUROS) into International Epidemiological Consortia to Inform Cancer Clinical Course and Disease Epidemiology

Publication Number: 929

Background: The Princess Margaret Cancer Centre (Canada) has led and participated in studies for several malignancies as part of international US NCI-funded cancer disease consortia including ILCCO (International Lung Cancer Consortium), VOYAGER (Human Papillomavirus, Oral & Oropharyngeal Cancer, Genomics, and Survival), and BEACON (Barrett's and Esophageal Adenocarcinoma Consortium). The use of BUROS (Basket/Umbrella Real-world Observational Study) ambispective (i.e., retrospective and prospective) design allows for the integration of data collected by the BUROS into international cancer epidemiology consortia.

Objectives: To assess the benefits and impact of using the BUROS platform on the research outputs of national and international cancer consortia.

Methods: We qualitatively evaluated the potential benefits of using the BUROS design and quantitatively analyzed the research output for these studies to assess the impact on different disease sites, data sources, and different types of outcomes.

Results: The Princess Margaret (PM) METAL (Molecular Epidemiology of Thoracic Lesions) BUROS has led to 94 lung, 36 gastro-esophageal, 5 mesothelioma, and 3 thymoma publications since 2006 inception; PM THANKS (Toronto Head And Neck Study) has generated 31 publications on oropharyngeal/oral cavity and other anatomic subsites since 2007. Further our PM BUROS data has been incorporated into several Cancer Epidemiology networks/consortia, resulting in involvement in 47 ILCCO, 7 VOYAGER, and 21 BEACON publications. These consortia were initially designed for disease epidemiology studies, but there has been a concerted effort to expand the scope to evaluate disease clinical courses. When collaborating within consortia, METAL BUROS and THANKS BUROS data were efficiently incorporated in a timely manner, because BUROS has the capability across many disease sites and subsites of having common study objectives, design, and data elements, which significantly improves the efficiency of establishing academic data transfer agreements and data harmonization across studies by the METAL and THANKS BUROS.

Conclusions: BUROS is an innovative study design that can contribute significantly to disease epidemiology and clinical course studies developed within international epidemiological consortia.