Statement by FDA Commissioner on new strategies to modernise clinical trials to advance precision medicine, patient protections and more efficient product development


14 March 2019 - Modernizing clinical trials is an agency wide priority. 

As more diseases are being redefined based on genomic subtype, researchers have more novel targets and more opportunities to precisely modulate or even repair the basic biological drivers of illness. Precision guided medicines can demonstrate strong efficacy signals in early clinical trials, including in trials where small groups of patients are selected based on biomarkers or other criteria suggesting they’re likely to benefit. 

These trials can potentially allow earlier regulatory assessment of benefit and risk. When the agency can make a positive approval decision, patients can gain earlier access to important new therapeutic options. 

To take advantage of these innovations, the agency is also seeking new ways to modernise its approaches to accommodate these novel opportunities.

Read FDA statement

Michael Wonder

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Michael Wonder