March 11, 2020

'I was just devastated': What it's like for patients when a drug trial suddenly ends

Daily Briefing

    When a drug trial is cancelled, the news often crushes participants—especially if they hear the information from the media before researchers get a chance to contact them. With a focus on Alzheimer's drug trial cancellations, a new editorial in JAMA Neurology outlines how researchers can better navigate these situations, Paula Span writes for the New York Times.

    New case studies: Keep Alzheimer's patients safe at home and in the community

    'It's akin to a trauma': What it's like to learn your trial is cancelled

    On March 21, 2019, Biogen and Eisai announced that a "futility analysis" of the companies' Alzheimer's drug aducanumab showed it was not effective and that the trial would be discontinued. Biogen and Eisai later announced that a new analysis found that high doses of aducanumab seemed to slow Alzheimer's, and the companies said they would resume a new, open-label trial this month.

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    But for the more than 3,200 people in the original trial the news was a disappointing blow—and many learned about the trial's end from third-party sources.

    Researchers at the Penn Memory Center in Philadelphia, where John Poritsky—a  61-year-old patient with early-onset Alzheimer's disease—was participating in the trial, had wanted to give the trial participants the bad news, but they didn't have the chance to reach patients before the news started circulating, Span reports.

    As a result, Poritsky heard the news of the cancellation not from the researchers overseeing the trial, but from a friend via text message.

    "I was just devastated," Poritsky said of learning the news.

    Jason Karlawish, a geriatrician and co-director of Penn Memory who co-authored the editorial, said, "It's akin to a trauma, the news that's devastating and the surprising, out-of-the-blue way you learn it."

    Phil Gutis, a former Times reporter who was participating in the aducanumab trial, said the news "was a kick in the stomach." Gutis said he had learned about the end of the trial through a text from a friend. "There should be a better way," he said.

    Why researchers aren't able to deliver the news

    According to Span, many Alzheimer's drug trials are conducted by publicly held drug companies, which are subject to Securities and Exchange Commission (SEC) regulations that forbid companies from informing patients or investigators about the end of a drug trial before informing shareholders. To meet those requirements, companies typically issue press releases early in the morning to announce a trial's end, Span reports.

    In the past, drug companies were able to issue the press release and have time to contact patients before the news was printed in the papers, Span reports. But in the age of social media and a 24-hour news cycle, patients today often learn the news from Facebook announcements or calls from family and friends.

    Emily Largent, a bioethicist and researcher at Penn Memory who co-authored the editorial, said, "[T]his has become fast-moving news in a way it wasn't before."

    How the process could improve, according to a JAMA editorial

    In the JAMA Neurology editorial, Karlawish and Largent wrote that there are steps researchers can take to improve communication with patients in the event a drug trial is cancelled.

    For instance, Karlawish and Largent recommend researchers inform patients that there is a chance the trial can be suddenly halted during the informed consent process.

    In addition, Karlawish and Largent note patients could choose to subscribe to the drug company's news releases so that they would receive any cancellation announcement.

    Karlawish and Largent also say companies should follow up with participants to share both positive and negative results from the study and connect participants with support groups or counseling.

    For instance, in 2018 the Toronto Memory Center in Canada hosted a lunch for patients who participated in a trial that was discontinued and presented the results "to show them what their efforts had led to," Sharon Cohen, a neurologist and principal investigator at the Toronto Memory Program, said.

    She told the participants they were "medical heroes, taking risks to benefit themselves and others," and last year, the center gave several trial participants citizen-scientist awards (Span, New York Times, 3/3).

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