EVALUATION OF CURRENT DATA SOURCES IN EUROPE FOR THE CONDUCT OF REAL-WORLD STUDIES ON LUNG AND RENAL CELL CARCINOMA- A SYSTEMATIC LITERATURE REVIEW
Author(s)
Gridchyna I1, Manley Daumont M2, Yousif A1, Hirji I2, Lees M2, Salvo F3, Moride Y1
1Faculty of Pharmacy, Université de Montréal, Montreal, QC, Canada, 2Global Health Economics and Outcomes Research - Europe, Bristol-Myers Squibb, Rueil-Malmaison, France, 3Bordeaux University, CHU Bordeaux, Bordeaux, France
BACKGROUND: Real-world data are required to fully assess the value of treatments in clinical practice. Given the importance of having all available data to make this assessment, while ensuring efficiencies in preventing duplication of data collection, the absence of a central repository of longitudinal data sources on cancer patients in Europe remains a challenge. OBJECTIVES: i)Identify and characterize existing traditional and non-traditional data sources on lung cancer and renal cell carcinoma (RCC) patients in Europe; ii)Determine the utility of each identified data source for real-world research. METHODS: A systematic literature search was conducted using MEDLINE and Embase(01/01/06-20/12/13). MeSH and Emtree terms included the following concepts: lung cancer (small-cell and non-small-cell), RCC, real-world data (registry, cohort, etc), and European countries. Clinical trials, case reports, case series, literature reviews were excluded. Identified abstracts were screened and reviewed based on relevance to key concepts. For each data source, utility was assessed using the following variables: country, setting, type (e.g. registry, EMR, etc.), clinical and baseline characteristics, tumor, biomarkers, test results, treatments, clinical and patient reported outcomes, resource utilization. RESULTS: The search yielded 2,478 abstracts for lung cancer and 698 for RCC. Following screening, 192(7.7%) and 102 (14.6%) were retained respectively. Data sources for lung cancer were equally distributed between general cancer and tumor specific registries. Most originated from the UK (33.3%) or France (13.8%). RCC data sources were primarily tumor specific and local with population size ranging from 56-1800. Data sources originated from Italy (22.5%), France, UK, and Germany (each 16.7%). Gap analyses with respect to the availability of specific data elements and utility for outcomes research will be presented. CONCLUSIONS: Data sources on cancer are highly fragmented in Europe, especially for RCC, emphasizing the need for database mapping. Completeness and consistency of the data elements needed to support technology assessments are variable.
Conference/Value in Health Info
2014-05, ISPOR 2014, Palais des Congres de Montreal
Value in Health, Vol. 17, No. 3 (May 2014)
Code
PRM44
Topic
Real World Data & Information Systems
Topic Subcategory
Reproducibility & Replicability
Disease
Oncology