The need for even further progress with clinical trial data sharing efforts: patients are waiting

Abstract

The Johnson & Johnson vision for data sharing We believe in responsible sharing of clinical trial data that advances science and respects individual participants, who give their time and even take risks to contribute to medicine. In keeping with that belief, our company, Johnson & Johnson (NJ, USA), has established a data sharing agreement with the Yale Open Data Access Project, an independent academic institution, to review and decide, based on scientific merit, whether requests for access to our clinical trial data, for both pharmaceutical and medical device products, will be fulfilled [1]. Sharing clinical trial data has the potential to improve public health by providing a better understanding of physiology and pathophysiology, as well as both the benefits and risks of all types of treatments, including medicines and devices. Importantly, it also enables a powerful approach to address important questions that could not be addressed within individual studies by using either a combined analysis or metaanalysis, enabling a far deeper understanding of diseases, subgroups of patients who might respond differently and strengthening the evidence base for future studies, treatment guidelines, r egulatory, payer and medical decisions [2]. Recently, the Institute of Medicine released a comprehensive report, which offers recommendations for responsible data sharing and a vision of an ecosystem in which clinical trial data from all sources are more broadly accessible to the research community [3]. We support the Institute of Medicine’s recommendations and agree on the need to move forward, through multistakeholder groups, some of which are already working on various aspects of data transparency and approaches to harmonization, including the multiregional clinical trial forum [4] and TransCelerate [5]. We agree that the greatest value from data sharing efforts will only be realized if data sharing is agreed and embraced broadly. This will require all stakeholders who conduct clinical trials of all types and of all interventions to participate in data sharing, as well as an effort towards more common data collection tools and standards. Of course, all efforts have to be aimed at maintaining the highest possible scientific principles.