Today, The New York Times reported on the experience of some participants in the recent Alzheimer’s aducanumab trial. The volunteers, who took part in the study at the University of Pennsylvania, learned of the study’s closure only after it was reported in the news. Reporter Paula Span writes:
This drug study, a Phase 3 trial, had allowed [the participant] to think not only that he might benefit personally, but that he could help advance science. “I thought, I can be part of something that can cure or arrest this illness,” he said. When the plug was suddenly pulled, “I was just devastated.”
As the article notes, trials sponsored by publicly held pharmaceutical companies are obligated to follow federal Securities and Exchange Commission (SEC) regulations for disclosing information with potential to move financial markets. This complicates the process of notifying patients or investigators before notifying shareholders “with distressing frequency.” The Times adds:
The [University of Pennsylvania] researchers wanted to be the ones to break the bad news to the 18 participants they had recruited. “When this effort you contributed months and years to is ending, that’s something you want to hear from people you trust,” said Emily Largent, a bioethicist and researcher there.
Our Foundation is taking multiple approaches to increase the flow of volunteers into clinical trials — a critical need if we are to accelerate the development of better treatments and cures. For brain diseases like Parkinson’s and Alzheimer’s, participation in trials frequently can require a serious commitment of time, energy and a fair dose of courage to endure occasional discomfort. This is true partnership with the medical research enterprise, and trial sponsors should do everything possible to recognize it as such. We are heartened by Dr. Largent’s recent opinion piece published by the medical journal JAMA Neurology, suggesting an opportunity to work within SEC regulations while respecting volunteers:
[…] Participants may be given the choice to receive any press release issued by the pharmaceutical company about trial closure at the time it is issued on the condition that further, personal communication with the study site will follow. While notifying participants via a press release is impersonal and not on its own sufficient […] it would address participants’ concerns that they are often the last ones to learn that a trial has been stopped early.
Every study brings us closer to cures. Even those that do not reach completion or that find a drug did not work help pivot resources to the next great idea with potential to reach the finish line. Learn more about how you can help bring new treatments closer to market.