All posts by Patty McAdams

Volume 4, May 2018


The Importance of Diversity in Clinical Research
Despite what is known about how certain groups of people may respond differently to disease; traditionally, the majority of cardiovascular clinical research study participants are white men. Increasing diversity in clinical research studies is a priority for the Food and Drug Administration and the ADAPTABLE team in making sure results provide evidence that is relevant and helpful to a wide range of people. Diversity in clinical research studies helps ensure that the results will have an impact on the people the study is intended to help.

VIEW NEWSLETTER FOR MAY 2018 (pdf)

 

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Volume 3, February 2018

Celebrating Your Heart and Heart-Health Awareness & American Heart Month.
Heart disease is the leading cause of death for American women and men, responsible for one in four deaths in the U.S. According to the Centers for Disease Control and Prevention, someone in the U.S. has a heart attack every 40 seconds, and every year 790,000 Americans have a heart attack. For 210,000 people this is their second heart attack. Unfortunately, once you have had a heart attack, your chance of having another one increases. The good news is that there are actions you can take to protect your heart.

VIEW NEWSLETTER FOR February 2018 (pdf)

 

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Volume 2, October 2017

Better health outcomes for all when patients partner with researchers.
This motto crafted by the Adaptors, ADAPTABLE’s patient partners, reflects how patient participation in research can help answer health questions that matter most to patients and their doctors. The Adaptors’ motto is part of the Hero’s Journey Art Project, a touring art exhibit developed by Eli Lilly to honor clinical trial participants and raise awareness of clinical research.

VIEW NEWSLETTER FOR October 2017 (pdf)

 

Volume 1: Welcome, June 2017

Thank you for your participation in the ADAPTABLE Study.

Your involvement in this research study will help us to answer a simple, but extremely important question—what is the best aspirin dose (81 mg or 325 mg) for patients with heart disease? In addition to answering the aspirin-dose question, ADAPTABLE is building a community where patients are partners throughout the research process.

 

VIEW NEWSLETTER FOR June 2017 (pdf)

When Patients Partner with Researchers: Desiree’s Perspective

In ADAPTABLE, patients are more than study participants, they are partners with researchers and clinicians to improve cardiovascular health for all patients and those who care for them. Adaptors are patient representatives who have been involved in ADAPTABLE from the beginning. The Adaptors team works alongside the study team, participating in team meetings and providing review and input to the protocol, consent form, study portal, and study materials.

We talked with one of the Adaptors, Desiree Davidson, who provided her perspective on the value patients bring to clinical research, the importance of patient-centered research, and the ADAPTABLE experience.

How can patients inform researchers in clinical trials?

Goodness, how did we do research before? After participating as an Adaptor in Adaptable, I wonder how research could be done any other way.  There are plenty of patients that do not feel comfortable relaying their concerns to their physician.  When we have a doctor’s appointment we are going to see a physician or a nurse, not a guy in a lab coat! We do not see our care providers as researchers and it feels like there has been a barrier between patients and researchers, that is concerning to me.  This model of patient-centered research is an opportunity to advance medicine, in my opinion.

What activity do you appreciate most from your work on the ADAPTABLE Study?

If are worried about talking to your doctor, you might feel it is easier to talk to a researcher. There is some fear once you get to a certain age, especially if you have been healthy all your life. The fear is related to not wanting to face the challenges of aging and being open to accepting what the physician may have to say. This comes back to education, you need to educate yourself about what can happen—to be able accept that somewhere along the line, you are fallible. For example, high blood pressure doesn’t hurt, it causes no pain. When I went to the doctor, the nurse told me my BP was high. I thought OK—the severity of having high BP for years is my responsibility to know. If I knew this back when I was 40, it would have made a difference to me, knowing what I know now, it matters! This is the kind of information you can get from a researcher. So now I have begun to educate myself. This role of clinician/ researcher is so important. A doctor may see 25 people a day, let’s say 18 of them have high blood pressure, and this conversation will not happen with the doctor. For the patient they think it is someone else who will have high BP, someone else will get diabetes. You do not think it will be you, maybe the doctor thinks this conversation has happened already. Ultimately the patient needs to have this conversation with their doctor, but the other hand, the patient needs to be willing to hear what the doctor tells them and take it upon themselves to get educated.

We have to learn to be comfortable asking questions, because an uncomfortable conversation today about a life-threatening condition, down the road in a certain context, is not really that uncomfortable.

What activities or hobbies do you enjoy outside of your clinical research activities?

I have always fallen into the role of teaching people. My first job was in a manufacturing company, my job was to explain insurance benefits to a labor force. This was something I fell into, and it was easy for me. This role as a patient leader feels natural to me. I was in personnel management for 37 years, and it was the easiest thing in the world to talk to people and teach them something new. I guess I have never had to work hard, this role is the easiest thing for me to do!

Importance of Diversity in Clinical Research

The main phases of a clinical research study include: 1) identification and recruitment of study participants, 2) data collection and monitoring, 3) analysis of study results, and 4) distribution of study findings. ADAPTABLE team members are currently focused on the first two phases. In this article, we explore why it is important that people of different ages, races, ethnic groups, and genders are included in clinical trials.

How Does Who you are Impact Your Risk for Disease?

Sex, age, race, and ethnicity all play an important role in how different diseases, medicines, and treatments affect people. For example, the American Heart Association (AHA) states that the prevalence of high blood pressure in African-Americans is the highest in the world. African-Americans are disproportionately affected by obesity and more likely to have diabetes than non-Hispanic whites. The Centers for Disease Control and Prevention (CDC) estimates that for American Indians/Alaska Natives and Asian Americans/Pacific Islanders, heart disease is second only to cancer. Heart disease affects women as much as men, but symptoms and the warning signs for women aren’t the same as in men.

Despite what is known about how certain groups of people may respond differently to disease; traditionally, the majority of cardiovascular clinical research study participants are white men. Increasing diversity in clinical research studies is a priority for the Food and Drug Administration and the ADAPTABLE team in making sure results provide evidence that is relevant and helpful to a wide range of people. Diversity in clinical research studies helps ensure that the results will have an impact on the people the study is intended to help.

How Can Researchers Work to Improve Diversity in Clinical Research?

So how do researchers work to ensure representation from a range of participants in clinical research studies? The short answer is education, trust, partnership, and access.

Providing Education: Too often people who choose not to participate in trials say that they lack information. Providing educational resources about clinical research—what it is, why it is important, and how to participate—is a good first step to filling this information gap and increasing participation of underrepresented groups. To be effective these resources must be written in plain language, culturally appropriate, and available in local languages.

Establishing and Building Trust in Communities: Lack of trust in clinical research by minority groups continues as a reason individuals decline participation in trials. PCORnet, the National Patient-Centered Clinical Research Network, is leading a shift in its approach to clinical research from the traditional sense of work that is done to the community to work that is done with the community. PCORnet has hosted events focused on fostering trust in clinical research and provides patients, caregivers, and others opportunities to partner with researchers to improve the clinical research process.

Involving patients as partners: By sharing their experiences on what it’s like to live with a disease, thoughts on treatments, and what research topics are most important, patients can make a significant impact on all aspects of clinical research, from the design of the study to the dissemination or sharing of the results.  In ADAPTABLE, a diverse group of patient partners called the Adaptors are integral team members who are passionate about representing and reflecting the best interests, concerns, and welfare of potential, current, and future clinical research participants.

ADAPTABLE team members frequently participate in community health fair events to provide information about clinical research, the ADAPTABLE study, and heart-health awareness. These events provide opportunities to engage with people, to make personal connections, and build trust with community members.

Jacqueline at a local health event talking about ADAPTABLE and heart health.

As a woman of color and a heart disease patient, Adaptor Jacqueline Alikhaani, is passionate about using her personal health experiences to not only heighten awareness of patient-centered research, but to enhance diversity in clinical trials. “One of the biggest advantages we have with ADAPTABLE is the diversity of the Adaptors team. We have women, men, and people from different races, ethnic, and socioeconomic backgrounds. We are bringing a wealth of experiences to help shape the design and direction of the study,” says Jacqueline. You can learn more about Jacqueline and how she serves as an architect of change in spreading the word about the role of patients in research and increasing minority participation in clinical research.

 Providing access to research: When designing a clinical trial, researchers plan to have study sites spread across the country and located in racially diverse communities to increase participation from everyone. ADAPTABLE enrolls participants from large health systems that are part of PCORnet’s Clinical Data Research Networks.

Want to learn more?

 If you are looking for general information about clinical research or resources about diversity in clinical research, check out the following resources:

Center for Information & Study on Clinical Research Participation

Minorities in Clinical Trials Fact Sheet

Engagement in Research