rwaitman
commented
8 years ago Hi Jason, We have a working group focused on data sharing and some pragmatics for the network from a structural perspective.
The topic of sharing results had been brought up by Chris.
There are many factors here at play between open science relative patient privacy/engagement, stakeholder engagement and support, the needs of a sponsor, the needs of an investigator.
It would be helpful for you to share your draft along with some more detail on the envisioned size and budget of the pilot and which portions of the data sharing landscape it seeks to probe. We can then sequence it for the data sharing working group and the committee to discuss,
Russ
I hope this finds you well. By way of introduction, I’m Jason Gerson, a Senior Program Officer in the Methods Program at PCORI. One of my roles is to help lead PCORI’s efforts concerning open science. As a funder of clinical trials and observational studies with a commitment to data transparency and data sharing, PCORI has developed a draft policy on Open Science and Data Sharing. As a next step, we are planning a pilot exercise in order to refine the operational and technical aspects of the draft policy. The Pilot Project we are envisioning will greatly assist PCORI staff in our efforts to more widely implement data sharing for the studies we fund. It will provide critical information about the feasibility of a data sharing requirement and the organizational resources needed to support this requirement. More broadly, our intent is to persuade our Research Awardees of the scientific benefits of data sharing, and to make clear to the public that such efforts are in keeping with PCORI’s mission to rigorously build the evidence base of clinical practice. We have been recruiting a number of awardees from across the portfolio to participate in the pilot. Those that participate in the pilot will engage with a few data repositories, with the goal of having their study data and data documentation (study protocol, meta-data, analytic code) deposited in one of these repositories.
It’s always been our intent to include a PCORnet study in this open science pilot. To that end (and with Rachael’s blessing), I spoke with Chris and Jason (Block), who are leading the pediatric obesity/antibiotic study. It became very clear in that conversation that there are many regulatory requirements that constrain PCORnet from participating in data sharing in the same way as PCORI’s non-PCORnet studies. Chris shared the DSA and an example of the Study Designation Approval Letter to help me better understand these requirements. That said, Chris and Jason see an opportunity to pursue some form of data sharing in PCORnet (for example, the sharing of aggregate query results that could be deposited into a data repository at a certain point in time). To that end, they suggested that I explore this further with the PCORnet Data Committee.
I understand from Maryan and Nicole that the Committee is meeting next Thursday, 7/14, at 4-5PM eastern. Perhaps it’s premature to put this on the agenda for discussion next week. However, if there’s time on the agenda perhaps I can introduce myself and the pilot to the Committee and tee up some issues for future discussion.
I’m happy to respond to any questions or comments you have.
All the best, Jason
Jason Gerson, PhD Senior Program Officer, CER Methods Patient-Centered Outcomes Research Institute (PCORI) 1828 L Street, NW 9th Floor, Washington, DC 20036 O 202.627.1878 | M 202.740.2046| F 202.355.9558 jgerson@pcori.org | www.pcori.org | @PCORI