The legislation positively affects the field in the following ways:
• The FDA may now consider real-world evidence, allowing study data evidence of, as opposed to requiring full clinical trial records.
• The FDA and stakeholders must collaborate on standards development.
• Sources such as patient registries, EHRs and other collected data outside of the clinical trial process will likely play a role in the risk-benefit assessment.
“The 21st Century Cures Act speaks very loudly for patients with unmet clinical needs who have little or no other available treatment options,” said Steven A. Brody, MD, PhD, StemGenex chief scientific officer. “Patients’ voices were heard and taken seriously.”
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