MELODEM leadership response to the FDA accelerated approval of aducanumab to treat Alzheimer’s Disease
With the recent controversial FDA accelerated approval of the drug aducanumab to treat Alzheimer’s Disease, MELODEM leadership has been considering what they are able to do to address concerns over the safety and efficacy of this drug. Dr. Maria Glymour, a founding member of MELODEM and professor in the UCSF Department of Epidemiology and Biostatistics has created a designed proposal for the rollout of aducanumab to mirror a stepped wedge design. To read more on the concerns that the leadership team has regarding the accelerated approval of aducanumab, and on the design proposal, please view the document below.
Pragmatic Study Designs to Accelerate Aducanumab Evidence_Glymour