Re-framing clinical trials needed

Bonnie Feldman drbonnie360@gmail.com

Abstract

Improving the diagnosis and treatment of autoimmune diseases (and other complex chronic diseases) is a major unmet medical need that calls for a re-framing of clinical trials using new digital tools and big data. 

New techniques, such as immune repertoire sequencing, phenotype/genotype, microbiome and other -omics and biometric data offer new ways of understanding the delicate dance of the immune system and how it goes awry in autoimmune diseases. Advances in the collection, storage, manipulation and analysis of large data sets are fundamental to this understanding. 

Yet, the clinical trial process has not yet made much use of these new sources of data. Furthermore, digital advances: mobile, social, apps, APIs, cloud, are only beginning to be applied to make clinical trials faster, cheaper, and more informative. How can we re-imagine clinical trials, asking new and better questions, using iterative thinking, to help those with autoimmune disease? How can we rally patient communities to encourage data donation to a central autoimmune registry?

Case studies may include, MMRF, Genetic Alliance, Open Medicine Institute, Clinipace, Cliniops, Transparency Life Science, ePatientfinder and others

 

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