In a bid to solicit input on how to responsibly share data from clinical trials, the Institute of Medicine has released a "discussion framework" and key questions to be addressed.
Clinical trials on drugs, medical devices and procedures generate vast amounts of data that might be shared to glean new insights and a sounder basis for clinical care. Yet the question remains how to share such data more broadly while still protecting the privacy of study participants.
The IOM is seeking input on this issue from researchers, clinical trial sponsors, patients, advocacy groups, other stakeholders and the public, according to an announcement. Such policies already are in the works in Europe.
The framework presents preliminary guiding principles, including respecting the individual trial participants, maximizing benefits to them and to society while minimizing harm, increasing public trust in clinical trials, and sharing data in a manner that enhances fairness. It also addresses what data might be shared, who provides or receives shared data, and whether access to data will be controlled.
The key questions include:
- What measures should be taken to minimize the privacy and confidentiality risks to trial participants?
- How can clinical trial data be shared in a global context?
- What might be the advantages and disadvantages to various stakeholders of sharing different types of datasets at different points in time after completion of a clinical trial?
Comments may be submitted at public workshops to be held Feb. 3-4 and May 5 in Washington, D.C., or through the project website. The IOM's data-sharing committee plans to release its final report in late 2014.
More than 70 major research and healthcare organizations from 41 countries are collaborating on a a framework for sharing genomic data worldwide. The aim is to break down silos of information at each institution, aggregating data in massive databases to develop new treatments for genetic diseases.
The European Union also has made a major investment into research involving crowdsourcing on rare diseases.
In the U.S., the Patient-Centered Outcomes Research Institute (PCORI) in December approved $93.5 million to fund a "network of networks" to provide access to a large amount of diverse data for comparative effectiveness research.