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July 14, 2021
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
Updated: MELODEM statement on aducanumab
In response to the recent controversial FDA accelerated approval of aducanumab to treat Alzheimer's Disease, MELODEM leadership created a statement addressing the need for treatment rollout that is structured to deliver clear and timely evidence on efficacy. This is an updated version of that statement (the former version in past post has been taken down). To read the statement, please view the document below.
MELODEM statement on aducanumab
In response to the recent controversial FDA accelerated approval of aducanumab to treat Alzheimer's Disease, MELODEM leadership has created a statement addressing the need for treatment rollout that is structured to deliver clear and timely evidence on efficacy. To read the statement, please view the document below.
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