On March 30-31st, 2015 over 70 committed international stakeholders joined together at the Harvard Faculty Club to discuss solutions to Clinical Trial Data Sharing.
Prior to the conference, Deloitte partnered with the MRCT Center to identify common principles, views on data sharing, and methods for sharing of participant level clinical trial data across a cross-section of those anticipated to attend the conference.
Interviews conducted with 21 individuals from industry, foundations, and academia identified common principles for sharing of participant level clinical trial data. Interviewees supported the sharing of data to advance science and improve public health if the following were given:
- Protecting patient rights and privacy
- Ensuring responsible conduct of research and good stewardship of data
- Maintaining incentives for those who generate data to conduct new research
The survey also showed that 100% of respondents supported the value of data sharing and the aggregation of data, but specifics of what data to share varied from making all data available to making data available on request after internal review for legal and competitive risk. A central system that allows for interoperability was widely considered to be the preferred option, however, many challenges needed to be addressed, including:
- Use of common data standard
- Resources to anonymize data
- Data repository for academics
- User friendly system
- Ability to combine data easily
- Common criteria or common review board
- Governance of the central system
Moreover, to improve transparency, interviewees plan to or are currently publishing metrics of data requests and track reasons for denial. Data from respondents show that 93% of data requests have been approved, though the time for approval varied widely. Reasons for denying a request for data include: proposal lacks clear scientific merit, data requested is not appropriate for the study proposal, Data Use Agreement was not signed, out of scope for informed consent, etc. To achieve a shared vision for an interoperable system, key process points should be harmonized such as proposal review, uploading data, system framework, and end of study requirements. The full results may be accessed here.