Open science: The open clinical trials data journey

Abstract

Open data sharing and access has the potential to promote transparency and reproducibility in research, contribute to education and training, and prompt innovative secondary research. Yet, there are many reasons why researchers don’t share their data. These include, among others, time and resource constraints, patient data privacy issues, lack of access to appropriate funding, insufficient recognition of the data originators’ contribution, and the concern that commercial or academic competitors may benefit from analyses based on shared data. Nevertheless, there is a positive interest within and across the research and patient communities to create shared data resources. In this perspective, we will try to highlight the spectrum of “openness” and “data access” that exists at present and highlight the strengths and weakness of current data access platforms, present current examples of data sharing platforms, and propose guidelines to revise current data sharing practices going forward.

The Net Benefit of a treatment should take the correlation between benefits and harms into account

“…3,[17][18][19]31,32 There has been a recent push to making data from randomized trials available for further analyses, so there is good hope that in the future, benefit/harm analyses will be possible that are at once mathematically correct and patient-relevant. [33][34][35] Table 1. Fictitious trial: probabilities of response and toxicity by randomized treatment group, assuming no toxicity in the control arm (N/A, not applicable).…”

Discoverability of information on clinical trial data-sharing platforms

“…Also, four of the seven platforms allowed users to download all available datasets onto personal devices, whereas three platforms only allowed users to access datasets in platform-specific online environments. Requiring researchers to submit separate data requests and limiting data access to platform-specific environments may reflect platforms' and researchers' fears of violating patient privacy, as these measures would allow for greater control and security of data; however, these additional hurdles may discourage researchers from reusing a dataset [ 25 ]. While information on whether users may download datasets onto personal devices was readily available on each of the platforms' websites, information on whether datasets could be requested on a batch level was more difficult to find.…”

Infectious diseases epidemiology, quantitative methodology, and clinical research in the midst of the COVID-19 pandemic: Perspective from a European country

“…As far as clinical research is concerned, there has been a remarkable push towards sharing of individual patient data for a number of years, both from publicly-funded trials but also from the pharmaceutical industry [103]. The goal is to share individual patient data from all completed trials within reasonable time after their completion so as to allow for further analyses of these patient data, as well as to help the design of other trials.…”