Summary: Media coverage of the FDA-approved Alzheimer’s drug aducanumab made the public less willing to volunteer in Alzheimer’s pharmaceutical trials.
Source: UC Irvine
When the U.S. Food and Drug Administration gave controversial accelerated approval to the first Alzheimer’s drug in nearly 20 years, it had a surprising impact on attitudes about research into the disease.
A survey by University of California, Irvine neuroscientists has found news coverage of the FDA’s decision made the public less willing to volunteer for Alzheimer’s pharmaceutical trials.
The study was conducted by the UCI Institute for Memory Impairments and Neurological Disorders, known as UCI MIND. It appears in the Journal of Alzheimer’s Disease.
The UCI team performed the survey in tandem with the FDA’s spring 2021 consideration of aducanumab. The monoclonal antibody reduces brain plaques, an Alzheimer’s hallmark, in people with the condition.
A panel of outside experts advised the FDA against approval, saying aducanumab’s ability to decrease plaques hadn’t shown an impact on the disease’s clinical progression. The agency’s controversial go-ahead and further disaccord over the drug’s labeling and price captured widespread media attention.
The UCI MIND researchers conducted their study among people aged 50 to 79 who had expressed willingness to take part in drug research. Two weeks before the FDA’s decision, UCI MIND asked respondents if they would be interested in enrolling in a hypothetical four-year study of a plaque-reducing monoclonal antibody and a plaque-preventing drug known as a BACE inhibitor. Eight days after the FDA gave aducanumab the green light, UCI MIND sent survey participants a similar questionnaire with a new section about the monoclonal antibody and its approval.
“We found those who had heard about the FDA decision before our follow up became less willing to take part in a drug trial,” said neurobiology & behavior graduate student Marina Ritchie, corresponding author of the paper.
“The people who learned about it from our materials demonstrated absolutely no change in their willingness.”
UCI MIND Director Joshua Grill added: “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. We believe it could be evidence of the powerful influence of media coverage of science.”
The survey’s findings may offer important insights for Alzheimer’s disease researchers. “Alzheimer’s is the most important medical condition society faces and we need an army of citizen volunteers to participate in drug trials,” said Grill, a professor of neurobiology & behavior and psychiatry & human behavior.
“Anything that diminishes credibility in scientific research impedes our progress. Media coverage has the potential to influence people’s choices. That can hold us back or push us forward.”
The findings also show researchers need to be aware of sample bias. It occurs when people with certain characteristics participate in a study at a higher rate than others without those traits or if some research population segments are not fairly represented.
“It’s crucial for trial participants to reflect the scope of people affected by the disease,” Ritchie said. “One thing we don’t know is whether the impact of media attention may be more or less important for particular groups, especially groups underrepresented in research.”
The UCI MIND team plans to conduct further research into the issue, with emphasis on learning how to better ensure diverse populations are part of Alzheimer’s clinical trials. “We need to understand what barriers to trust may exist and overcome them so our research is inclusive and applicable to everyone,” Grill said.
Funding: Funding for the project was provided by the UCI Alzheimer’s Disease Research Center.
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Author: Tom Vasich Source: UC Irvine Contact: Tom Vasich – UC Irvine Image: The image is in the public domain
Effect of Aducanumab Approval on Willingness to Participate in Preclinical Alzheimer’s Disease Trials
Background: Clinical trials now test promising therapies in the preclinical stages of Alzheimer’s disease (AD). Participant willingness to enroll in different types of preclinical AD trials is understudied and whether the FDA approval of aducanumab affected these attitudes is unknown.
Objective: To evaluate preferences toward three preclinical AD trial scenarios and whether the FDA approval of aducanumab changed willingness to participate among potential trial participants.
Methods: Through an electronic survey, we asked enrollees in a recruitment registry age 50-79 to rate their willingness (using a 6-point Likert scale) to enroll in three hypothetical preclinical AD trial scenarios: an in-clinic infused monoclonal antibody intervention, a home-infused monoclonal antibody intervention, and an oral BACE inhibitor intervention. We administered the survey before and after the FDA approval of aducanumab. We used a generalized estimating equation model to assess group differences in preference for the trial scenarios. We used a paired t-test to determine if willingness to participate (using total willingness across three scenarios as the outcome) changed after the FDA decision.
Results: At baseline, the mean participant willingness was highest in the in-clinic infusion scenario. There was no significant change in willingness to participate, overall, after the FDA decision. Participants who were independently aware of the FDA’s decision (prior to the second survey) demonstrated reduced willingness to participate; participants unaware of the FDA decision demonstrated no change.
Conclusion: Willingness to participate in preclinical AD trials may have been negatively affected by the FDA’s decision to approve aducanumab among those aware of the decision.