Faculty Opinions recommendation of US Food and Drug Administration Approval of Aducanumab-Is Amyloid Load a Valid Surrogate End Point for Alzheimer Disease Clinical Trials?

2021 ◽  
Author(s):  
J Wesson Ashford
Keyword(s):  
Clinical Trials ◽  
Alzheimer Disease ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
End Point ◽  
Amyloid Load

scholarly journals Accelerated Approval of Aducanumab: Where Do We Stand Now?

2021 ◽  
pp. 106002802110504
Author(s):  
Hedva Barenholtz Levy
Keyword(s):  
Alzheimer Disease ◽  
Drug Administration ◽  
Drug Company ◽  
Food And Drug Administration ◽  
Clinical Effectiveness ◽  
End Point ◽  
Informed Decisions ◽  
Accelerated Approval

Aducanumab was approved by the Food and Drug Administration (FDA) in June 2021 to treat Alzheimer disease (AD). Its path to approval has been highly scrutinized, with many experts arguing that the FDA’s decision was premature. Accelerated approval was based on a surrogate end point, with evidence to support clinical effectiveness pending a postapproval trial by the drug company sponsor Biogen. As a result, the role of aducanumab in treating AD remains uncertain. A summary of key areas of controversy to guide informed decisions about use of this drug is provided, along with a timeline describing preapproval and postapproval events.

Comments on the Draft Guidance on “Adaptive Design Clinical Trials for Drugs and Biologics” of the U.S. Food and Drug Administration

2010 ◽  
Vol 20 (6) ◽  
pp. 1125-1131 ◽  
Author(s):  
Werner Brannath ◽  
Hans Ulrich Burger ◽  
Ekkehard Glimm ◽  
Nigel Stallard ◽  
Marc Vandemeulebroecke ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Administration ◽  
Adaptive Design ◽  
Food And Drug Administration ◽  
Draft Guidance ◽  
The U.S

Participation of African American Persons in Clinical Trials Supporting U.S. Food and Drug Administration Approval of Cancer Drugs

2020 ◽  
Vol 173 (4) ◽  
pp. 320-322 ◽  
Author(s):  
Samer Al Hadidi ◽  
Martha Mims ◽  
Courtney Nicole Miller-Chism ◽  
Rammurti Kamble
Keyword(s):  
Clinical Trials ◽  
African American ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Cancer Drugs
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