Document Type

Article

Publication Date

6-2014

ISSN

0026-5535

Publisher

University of Minnesota Law School

Language

en-US

Abstract

We are pleased to have this opportunity to respond to Jonathan Darrow's article, Crowdsourcing Clinical Trials (CCT).' We seek to highlight its important contributions and to commence debate over some of its arguments. In particular, we qualify the ethical arguments that characterize early clinical use of drugs as if they were research, and suggest instead that, in either domain, the ethical (and legal) analysis should remain focused on whether all material information is provided so patients may make informed decisions. We also highlight the limits of what can be gleaned from the observational data collection efforts envisioned by CCT.

Ultimately, we exploit the core insights of CCT to expand the potential use of crowdsourcing from observational studies to truly randomized interventional trials. Randomized experiments allow causal inference because they assign subjects to a treatment and control group, and collect data from each. Furthermore, we draw attention to the fact that much of public health is driven not by pharmaceuticals, but by lifestyle factors. We suggest that CCT's envisioned platform for crowdsourcing also has great potential to engage the public in producing new and trustworthy knowledge in the domains of diet, exercise, nutritional supplements, and integrative medicine, which are primary drivers of health outcomes and spending.

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