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This Reverend Wants To Change How You View Clinical Trials: "We're Not Going To Have Another Tuskegee"
Rev. Anthony Evans of the NBCI Reaching Black people on major issues starts with going where they are. Historically, Black churches have been a resource and refuge in their communities, and they're helping to build trust with clinical trials.
The National Black Church Initiative (NBCI), a coalition of 150,000 churches, has been the driving force behind the National Clinical Trial Strategic Plan to educate and inform Black Americans about clinical trials. Their efforts have helped to educate over 52,000 Black congregants, making it the most successful mission to close the clinical trial racial gap.
That success is in major part due to trust and cultural competency. "We're proud to be working to educate and provide informed consent," Rev. Anthony Evans, the President of the NBCI explains to BlackDoctor.Org. There is also a level of protection since they vet the clinical trials before putting them before congregations. "I tell them that you have to verify through us that you're going to provide critical education, and you can't do that without going through the American Clinical Health Disparities Commission."
NBCI's partnership with the American Clinical Health Disparities Commission (ACHDC) is aimed at a continued effort to combat health disparities including social determinants of health. ACHDC is made up of Black physicians, clinicians, and church leaders who are working to improve Black participation and clinical trials.
The commission's 42 physicians provide technical and scientific protocol as well as guidance, Evans says. This will inform the National Clinical Trial Strategic Plan. "I can't do anything until I pass the nature of whatever clinical trial they are doing through the commission, and the commission will authorize me to implement that program in our community saying that this is a reputable program."
The partnership's major goal is to close the health gap with Black Americans. While NBCI has struggled to be heard by Congress and elected officials, the hope is that their efforts allow them to have meaningful connections with the NIH and other bodies that could lead a large effort to slow down Black mortality. According to Evans, "We are working with a couple of continuous education firms to offer a course of how to deal with Black American patients. Non-Black researchers know nothing about African American traditions, so we are creating this course to make sure that they know about us and respect our culture."
"The reason why we are so formal is that these are lessons learned from Tuskegee," Evans added. "We're not going to have another Tuskegee on our watch." The Tuskegee Study of Untreated Syphilis stripped Black men infected with syphilis of informed consent and withheld medication. This led to lifelong health problems for participants and their families.
That is why engaging organizations like the CDC and NIH are important. Evans hopes that within the next few years, over 750,000 congregants will be introduced to clinical trials. Without the Black church, which is a soft place for many in the community to land, Black people may steer clear of trials and studies. "We can't do this alone, especially since we're late," Evans concludes."This should have been done 20 years ago, 30 years ago, but it is what it is, and that's where we are."
Clinical Trials: A Guide
It's when a team of scientists and doctors tries a new medical treatment, drug, device, or method on a group of people to test how well it works. The purpose of a clinical trial is to find a new and improved way to treat, prevent, or diagnose different types of illness.
In many cases the trial might be for something that is not yet available to the general population of people with an illness. Special allowances are made so doctors can learn more about how well a new approach works. They test the results against the best available current treatments with the goal of finding something better.
This could be especially useful if you have a serious illness and have run out of effective standard treatments.
Scientists first test these new treatments with laboratory experiments. Next, they try them on laboratory animals. Only when they deem them safe and useful enough in these early stages does a clinical trial start on people -- first in small groups and then in larger ones.
Clinical trials help doctors discover the answers to these questions:
There are several stages, or "phases," of a clinical trial. Each new phase builds on information from previous stages.
You might qualify for a certain phase of a trial because of the state of your health or the seriousness of your particular illness. People who take part usually do it in phase III or IV of the trial.
Almost all treatments carry some risk. The amount will depend on the type of treatment and on your general health.
In general, scientists don't know as much about how clinical trial treatments affect your body. So there may be more risk of unknown side effects than with already established treatments.
The doctors and nurses doing the trial will explain the treatment to you, including its possible benefits and risks, and then ask you to sign a release form that gives your consent to take part. This is your "informed consent."
Keep in mind that your signature does not bind you to the study. You can decide to leave the trial at any time and for any reason.
In addition, the informed consent process is ongoing. After you agree to a clinical trial, your medical team should continue to update you with any new information about your treatment that might affect your willingness to stay in the trial.
A trial is typically for a certain condition, and each phase might require a different level of symptoms. If you fit the guidelines for a trial, you may be able to participate. Sometimes you might need certain tests to confirm that you're a good candidate.
Your personal information is confidential and not attached to your name in the study.
If you are thinking about taking part in a clinical trial, find out as much as possible about the study before you decide to join. Here are some important questions to ask:
Clinical Trials Sparking Hope For Alzheimer's Patients: 'Holding My Own'
A nationwide clinical trial is testing whether an existing drug could benefit patients with Alzheimer's disease, in hopes of making symptom-improving medication more accessible for people experiencing mild cognitive impairment.
Patients participating will be helping to determine the potential benefits of taking a drug called benfotiamine— which researchers believe may delay or slow the progression of symptoms of early Alzheimer's disease.
Researchers say this treatment could be especially beneficial because the drug is converted by the body into Vitamin B1, or thiamine. That could lead to a better safety profile, be more cost-effective and be more accessible than other Alzheimer's medications, according to the researchers.
The nationwide clinical trial, called BenfoTeam, is being locally administered by MedVadis, a partner of Boston Advanced Medicine based in Waltham.
Dr. David DiBenedetto is the practice's director of research and is a principal investigator in the study.
A new study is tying high doses of common ADHD treatments like Adderall to increased risk of manic or psychotic episodes.
"If patients are having problems managing their activities of daily life — whether it's, again, keeping appointments, performing simple tasks or remaining independent — if we see improvements in those domains, it would mean something significant with this medication," DiBenedetto said.
Alzheimer's can have wide-ranging symptoms including memory loss, problems concentrating and thinking, even changes in mood and personality, according to Mayo Clinic. Over six million people 65 and over have the disease in the United States. In its advanced stages, Alzheimer's can cause complications that lead to death, including dehydration and infection.
At this time, there is no cure for Alzheimer's.
Patients in this study would have early forms of the disease, meaning their symptoms would mainly be limited to mild difficulties during everyday memory recalls and other tasks. Participants will either be given the benfotiamine or a placebo pill and will be followed for 18 months.
"The research is being done to determine the exact benefits of this drug," DiBenedetto said. "Hopefully it's not just slowing down the cognitive decline, but also reversing or improving cognitive function."
DiBenedetto said small studies have suggested that benfotiamine can improve cognitive function in Alzheimer's patients. The BenfoTeam trial is much larger, involving over 400 patients at 50 sites across the United States.
"I've done research for many, many years — this population of patients is the most altruistic and the most wonderful patient to work with," DiBenedetto said of Alzheimer's patients. "When they come in here, most times they're looking for a solution for the grandkids or for the people in our community."
That's the case for Tim Muther of Holliston. Now in his late 70s, he is living with Alzheimer's and is participating in a clinical trial in hopes of helping to contribute to the search for a cure.
It's an emotional topic for Muther. On top of living with the condition himself, he watched his father and mother-in-law decline from the illness.
He first began noticing his own cognitive decline while living in Florida, before moving back to Massachusetts to be closer to family.
"Forgetting things, you know, things that I either should have done or, you know, or things that I felt that I should know that answer," he said. "They just weren't there."
Muther was prescribed a medication by his doctor, and is also participating in a clinical trial separate from the BenfoTeam trial.
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"I'm hoping that by me participating and maybe I'll give some hope to others," he said. "I can feel some benefits from what I've been doing... I am holding my own."
One of Muther's children, Wendy Saracino, said it's been hard to watch her parents manage the condition.
"We have regular sort of family Zoom meetings and talk about how it impacts us, how it's impacting our parents, what we can do," Saracino said, who helps her father to participate in his clinical trial. "It actually is helping me be a better, I think, a better daughter, a better caregiver, doing my job here better because I feel like I'm making a difference."
With so much research into Alzheimer's, DiBenedetto said there's been no better time to have hope than now, and showed his gratitude to people like Muther for the critical role they play in medical breakthroughs.
"Everything that's come out in the market is because of people like Tim participating in trials," he said. "So I hope that people will well consider participating in research trials that can actually end this disease."
Currently, there are three FDA-approved drugs to treat symptoms related to mild to moderate Alzheimer's. Since last summer, the FDA has also approved two other Alzheimer's drugs that have been shown to modestly slow a decline in memory and thinking.
The BenfoTeam trial is still seeking study participants. More information is available here.
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