OBJECTIVES: The role of real-world data (RWD) in the development of antineoplastic treatments has been increasing over time. Many stakeholders now rely on RWD and the evidence derived therefrom to inform and support their decision-making with respect to anticancer therapies, including regulators and payers. However, the current RWD research landscape in oncology remains ill-characterized. The aim of this study is to gain insight into the experience that cancer cooperative groups have with working with RWD.

METHODS: We launched an online survey that was disseminated to cancer cooperative groups globally.

RESULTS: So far, 80 groups active across 51 different countries and 13 distinct cancer domains have provided responses to the survey. Although a large majority (74%) of the participating organizations indicated that they had experience with collecting and analyzing RWD, most (63%) did not have any formal policies in this regard. When RWD were used by the groups, these data were usually observational in nature, had often been extracted from patient registries or electronic health records, and were mainly intended to address questions relating to an antitumor intervention’s (comparative) effectiveness or its target population. Some of the responding organizations claimed to have undertaken pragmatic trials or studies employing the trials-within-cohorts design before (20% and 25%, respectively). Participants mostly viewed RWD as data generated in a non-interventional/non-controlled setting. The scale of RWD was seen as the most important benefit of such data, whereas the operational challenges of managing RWD were perceived as particularly difficult to overcome. Only a minority (16%) of the groups conducted more studies involving the collection and analysis of RWD than traditional clinical trials.

CONCLUSIONS: Cancer cooperative groups are already harnessing RWD to tackle research questions, but clinical trials continue to be their core focus. They have generally not yet carried out any studies that can produce interventional RWD.