< Terug naar vorige pagina

Publicatie

Real-world data in oncology: a questionnaire-based analysis of the academic research landscape examining the policies and experiences of the cancer cooperative groups

Tijdschriftbijdrage - Tijdschriftartikel

BACKGROUND: Real-world data (RWD) have quickly emerged as an important source of information to address uncertainties about new treatments, including novel anticancer therapies. Many stakeholders are using such data and the evidence derived therefrom to answer the questions that remain about the safety and effectiveness of antitumor medicines after their approval by regulators. Our objective was to investigate the academic RWD study landscape and explore to what extent RWD are being integrated into investigator-initiated clinical research. MATERIALS AND METHODS: We designed an online survey that was distributed between May and August 2022 to representatives of cancer cooperative groups active in Europe, North America, South America, Asia, and/or Oceania. RESULTS: In total, 125 cooperative groups operating in 58 different countries and conducting research across 13 distinct cancer domains participated in the survey. While most of the responders (67.2%) did not have a formal policy in place to gather and utilize RWD, a majority (68.0%) had carried out studies involving the analysis of such data before, both for exploratory and confirmatory purposes. The groups that were experienced in capturing and interpreting RWD had mainly worked with observational RWD that were not predominantly prospective or retrospective in nature and which originated from disease registries, electronic health records, and patient questionnaires. They perceived the low costs and the large scale of RWD research to be its most significant benefits, and viewed the accompanying methodological and operational challenges as its biggest constraints. However, they did not have a common understanding of what RWD were. Despite their experience with analyzing RWD, their research portfolio still primarily comprised traditional clinical trials; 62.5% of the groups that had never undertaken any RWD studies were nonetheless planning to initiate them in the future. CONCLUSIONS: Cancer cooperative groups are already incorporating RWD studies into their research agendas, but still lack knowledge and expertise in this regard, and do not agree on what RWD are. The conduct of conventional clinical trials continues to be their priority.
Tijdschrift: ESMO Open
ISSN: 2059-7029
Issue: 2
Volume: 8
Pagina's: 1 - 10
Jaar van publicatie:2023
Toegankelijkheid:Open