Applied Clinical Trials Online

June 7, 2016

By Bruce Bloom

The case for supporting off-label use or commercialization in drugs for “unsolved” diseases.

There are over 7,000 “unsolved” diseases for which patients have no universally successful treatment. There are also thousands of generic drugs that can be repurposed to help these patients. Built on knowledge from scientific discoveries, anecdotal evidence, and/or bioinformatics, generic drug repurposing research can often lead to quick and affordable development of “new” medical solutions. Once a generic drug repurposing opportunity has been identified, a key issue is whether the clinical trial validation should focus on supporting a path to commercialization or to physician off-label use. The direction of focus depends on the entity supporting the clinical trial development.


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