Study Explores Impact of FDA Approval of Aducanumab on Trial Participation

Individuals who were independently aware of the FDA decision demonstrated reduced willingness to participate
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TUESDAY, Dec. 6, 2022 (HealthDay News) -- The U.S. Food and Drug Administration decision to approve aducanumab may have negatively impacted willingness to participate in preclinical Alzheimer disease (AD) trials, according to a study published online Nov. 22 in the Journal of Alzheimer's Disease.

Marina Ritchie, from the University of California Irvine Institute for Memory Impairments and Neurological Disorders, and colleagues surveyed enrollees aged 50 to 79 years to rate their willingness to enroll in three hypothetical AD trial scenarios: an in-clinic infused monoclonal antibody intervention, a home-infused monoclonal antibody intervention, and an oral β-site amyloid precursor protein cleaving enzyme inhibitor intervention. The survey was administered before and after aducanumab approval by the FDA.

The researchers found that the mean participant willingness was highest in the in-clinic infusion scenario at baseline. After the FDA decision, there was no significant change in willingness to participate overall. However, participants who were independently aware of the FDA decision prior to the second survey were less willing to participate; no change was seen for participants unaware of the FDA decision.

"This is surprising, because it goes against some of our previous data showing people are generally more willing to take part in studies involving approved drugs compared to investigational ones," a coauthor said in a statement. "We believe it could be evidence of the powerful influence of media coverage of science."

Abstract/Full Text (subscription or payment may be required)

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