Recent years have seen growing support for making data more readily accessible, with the International Committee of Medical Journal Editors (ICMJE) data sharing requirement coming into force. The benefits for authors and researchers in sharing their data is beginning to be realised. However, challenges in accessing data and factors limiting data sharing have also been recognised.
In a recent opinion piece for STAT, Prof Ross and colleagues share their first-hand experience of data sharing with the Yale Open Data Access (YODA) Project. The YODA Project, which is co-directed by Ross, was launched in 2011 and partnered with Johnson & Johnson in 2014. It facilitates access to data via a controlled-access model that requires investigators wishing to use data to submit proposals to the YODA team for approval. Data are predominantly from non-Phase I clinical trials that have been completed for at least 18 months and around 95% of the trials available are sponsored by Johnson & Johnson. At the time that the article was published:
- Data were available from 350 trials – this has since grown to 389 trials.
- 117 requests for data access had been granted (using an average of three trials each).
- 26 manuscripts reporting data obtained from the YODA Project had been published in peer-reviewed journals.
The authors point out that data from over 75% of listed trials had been shared with and used by external investigators, far outstripping the 15% reported for other data sharing platforms.
Data from over 75% of listed trials had been shared with and used by external investigators, far outstripping the 15% reported for other data sharing platforms.
So, what has made the YODA Project so successful? The authors highlight the transparency of the controlled-access model, which makes information like clinical trial metadata publicly accessible, ensuring that investigators are aware of the available data. In fact, transparency and responsible practices are promoted throughout the process, with data sharing requests, reviews and results all made publicly available. The authors also note that while data had to initially be retroactively prepared for dissemination, Johnson & Johnson now begin all new trials with data sharing requirements in mind. Importantly, concerns surrounding the risk of breaching patient privacy, inappropriate use of data for commercial purposes, or publication of spurious safety findings, have so far been unwarranted.
The authors acknowledge the early challenges faced by the Project – particularly when preparing data from older trials. Subsequently, however, they have found that a lack of expertise among those requesting data has posed the most significant obstacle to the completion of analyses. The YODA Project is currently funded by the companies who use the platform, such as Johnson & Johnson. Looking to the future, the authors note the need to develop sustainable funding models to ensure that as data sharing increases, the costs can still be covered.