Clinical Trial Data: What Are The Benefits And Risks?
By Megan Williams, contributing writer
Summar The Institute of Medicine of the National Academies (IOM) has released a paper on the benefits and risks of sharing research generated data.
At present, much of the data from clinical trials is not published or shared with other researchers, meaning many opportunities for advancement and discovery are lost, as well as resources being wasted duplicating trial efforts. While sharing this information could provide multiple benefits, there are of course, risks associated with it.
To address the issue, the IOM pulled together a committee to create “guiding principles and a practical framework” to be used in sharing clinical trial data responsibly. The report, Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk, outlines those principles.
Guiding Principles
The IOM committee came up with the following four principles to guide the responsible exchange of clinical trial data:
- maximize benefits while minimizing risk
- respect individual participants whose data is being exchanged
- increase public trust in trials and sharing of trial data
- share data in a fair manner
The report acknowledges the importance of stakeholder investment in order to reach goals that the guidelines point to. “Collaboration among a broad set of stakeholders is needed to create a culture in which responsible data sharing is incentivized and best practices are disseminated widely. To foster such a culture, including strategies to develop infrastructure, oversight, and sustainability, the IOM report details specific actions for funders and sponsors of clinical trials; disease advocacy organizations; regulatory and research oversight agencies; research ethics committees or institutional review boards; investigators; research institutions and universities; academic journals; and membership and professional societies.”
The Importance Of Timing
Different types of data — individual participant data, metadata, and summary-level data — all carry their own particular risks and benefits in the exchange process. Because of this and their inherent relationship, timing is an issue. The IOM committee also came up with three goals that have to be balanced around timing:
- Allowing clinical trialists to publish results before secondary investigators are given access.
- Allowing secondary investigators access to unpublished trial data after a “fair period” to reproduce the findings that have been published.
- Protecting sponsors’ commercial interests in obtaining regulatory approval for a product so financial rewards can be received.
Risks, overall, the report states, can be managed by controlling which parties have access, and under what circumstances they do. The committee also believes that “open, public access” to trial data is appropriate for sharing trial results.
The Importance Of Tech
The report lists barriers to sharing data, all of which are directly related to the technology and include:
- Infrastructure: Current platforms used to store and manage trial data are insufficient.
- Technology: Data sharing platforms are not interoperable, neither are they consistently discoverable or searchable.
- Workforce: The workforce needed to manage the operational and technical aspects of data sharing are not currently available
- Sustainability: Costs are not equitably distributed across generators and users.