Data in the Cloud

by Julie Fine, BS, Legal Specialist, Worldwide Research and Development, Pfizer Inc., La Jolla, California

While the 2013 Advancing Ethical Research (AER) Conference has drawn to a close, PRIM&R is pleased to continue sharing reflections from members of the PRIM&R Blog Squad to provide our readers with an inside peek of the conference.

During the 2013 Advancing Ethical Research (AER) Conference, I attended two panels that challenged conventional wisdom about transparency, control, and crowdsourcing of research data. The first, Panel VII: Data Sharing on Steroids: Demands for Transparency of Subject-Level Research Data, touched on the increasing demand for transparency in clinical research on a broad scale, and included representatives from an institutional oversight organization and a pharmaceutical company, and a patient advocate, who shared their insights into data transparency.

The demand for public access to aggregate research results has lead biotech companies and the European Medicines Agency (EMA) to rethink the way in which data can (and should) be shared. Greater openness could generate opportunities to reassess research results and perhaps expand the utility of secondary analysis. It is important, however, that the process of gaining access to the data also be transparent.

The initiatives of the EMA and other biotechnology companies highlight the merits of legitimate, purposeful data sharing. That is to say, if a qualified researcher with a well-defined research proposal has no significant conflicts of interests and possesses the requisite skills to conduct the proposed analyses of the data, the sharing of research results can be highly beneficial. Still, such transparency does raise concerns, several of which were discussed by the panelists. For example, scientific inquiry and the public good may not be well served if uncontrolled open sharing leads to misuse or junk science.

The second, Panel VIII: Taking Control: Ethical Challenges for Participant-Centered and Participant-Led Research, examined instances in which participants become the driving force behind the initiation of, and at times actually take an active role in the conduct of, research projects. With the help of social media and other digital technologies, online communities can engage in projects with their own data outside of standard regulation-controlled research. Though crowd-sourced data and self-policed affinity groups may be a novel approach with certain advantages, it’s difficult at this stage to envision an FDA-approved drug entering the market from this model. What do you think?

Please note that the views presented here are Julie’s own and do not reflect the positions or policies of Pfizer, Inc.