Should You Consider a Clinical Trial?
ARE YOU OR A LOVED ONE INTERESTED IN PARTICIPATING IN A CLINICAL TRIAL?
Please discuss this with your doctor and visit the website alzheimers.gov for ideas. AFA also offers links to clinical trials at alzfdn.org/clinical-research-trials.
When AFA hits the road for its Educating America Tour, questions from audience members routinely come up about clinical trials. In response, Charles J. Fuschillo, Jr., AFA president and CEO, devoted one of AFA’s Fireside Chats to the topic, talking with Madhav Thambisetty, M.D., Ph.D., senior clinical investigator and chief, Clinical and Translational Neuroscience Section, National Institute on Aging, in a session called “Dementia Diagnosis Roadmap: Pipeline, Trials & Research—What’s It All About?”
“There’s always a fear that’s associated with clinical trials,” Fuschillo said. “It’s a term that many people have heard, but they’re not fully aware of what exactly it means.”
Thambisetty explained the term and how to counter the fear.
“Clinical trials are research studies that help us understand whether a new treatment or a diagnostic test is effective and safe in people. Oftentimes they are the main methods through which scientists, doctors like myself, assess whether they are more effective than existing treatments and diagnostic tests.
“Education is the key to increasing awareness of clinical trials in general and specifically in regard to fear being a barrier to participation. It’s a legitimate concern, one that has also emerged out of historical mistakes that were made in the era when clinical trials were not regulated, and we didn’t have the guardrails to ensure participant safety.”
However, he said strict rules now govern how trials are conducted. All must be approved by a committee of the Institutional Review Board, which is made up of doctors, scientists and sometimes members of the public.
“Today, every clinical investigator in the United States is monitored and follows a careful study plan, often called protocols, that lay out in extraordinary detail what researchers plan to do as part of the trial.”
Another safeguard is the informed consent, Thambisetty said.
“An informed consent has details about the study, what it’s goals are, how long it will last, what procedures the participants will undergo and whom to contact in case there are unexpected problems that develop.”
He recommended the following steps for those interested in participating in a clinical trial:
• Understand what the trial is aiming to do.
• Study the information about the procedures involved.
• Find out the time commitment required.
This information is available in the informed consent brochure, he said.
“The one thing I encourage my patients to do is ask questions. Get a good idea of what the potential side effects might be and understand what you might get out of the trial.”
The AFA Fireside Chat is an educational and informational web series open to family caregivers, professionals, clinicians and anyone else who wants to learn about Alzheimer’s and related dementias. Each episode features a topical discussion with experts from the fields of medicine, research and dementia care. Go to alzfdn.org/firesidechat to view the 2024 schedule and past episodes.
