Critical path initiative should centre on biomarkers and trial data
The FDA's Critical Path Initiative, which aims to expedite the drug development process and bring more products to market faster, should focus on the development of biomarkers and the standardisation of clinical trial data-gathering, according to the FDA's Science Board.
The FDA's Critical Path Initiative, which aims to expedite the drug development process and bring more products to market faster, should focus on the development of biomarkers and the standardisation of clinical trial data-gathering, according to the FDA's Science Board.
The agency should pick activities that would have benefits across the whole system but that also would have a high probability of getting results in a relatively short period of time, said Kenneth Shine, executive vice chancellor for health affairs at the University of Texas and chairman of the Science Board.
The initiative, announced in March, aims to streamline the drug development process by better predicting failures early during clinical trials. This would be accomplished by developing new predictive models, clinical evaluation techniques and biomarkers for establishing safety and efficacy.
To date, the initiative has generated 120 comments to the FDA suggesting projects. The two most frequently raised issues involve developing more efficient clinical trials and creating new biomarker or surrogate endpoints for establishing effectiveness standards.