A multi-stakeholder effort is necessary to create the culture, infrastructure and policies needed to further responsible data-sharing for clinical trials, an Institute of Medicine report finds.
Clinical trials generate vast amounts of data, but much of that information is never published or made available to other researchers. At the same time, protecting the privacy of study participants remains a pressing concern, according to the report.
The authors of the report say that sharing data is in the public interest, and offer a framework for data-sharing based on input gathered from researchers, clinical trial sponsors, patients, advocacy groups, other stakeholders and the public.
Beyond protecting patient privacy, there should be several goals when it comes to data sharing, the authors write. These goals include reducing the risk of invalid analyses or misuse, avoiding undue burdens on data users and harm to investigators and enhancing public trust in clinical trial data-sharing.
Among the challenges to achieving these goals, according to the report, are:
- Infrastructure: Storage and management capabilities are inadequate for the amount of data produced
- Technology: Data sharing platforms are not consistently discoverable, searchable or interoperable
- Workforce: Organization's don't have the staff to adequately manage the operational and technical aspects of data-sharing
When it comes to who should shoulder the costs of data sharing, the authors of the IOM report conclude that because shared data benefits all involved, including the public, insurers, healthcare providers and researchers, all should help pay for it.
There are many ways that the healthcare industry is taking advantage of data sharing, showing the importance of the practice.
More than 70 major research and healthcare organizations from 41 countries are collaborating on a framework for sharing genomic data worldwide. This effort focuses on breaking down silos of information at each institution, aggregating data in massive databases to develop new treatments for genetic diseases. And the European Union also has made a major investment into research involving crowdsourcing on rare diseases.
To learn more:
- read the report