Clinical Research for People in Asian Communities

CISCRP is committed to providing clear, unbiased, and culturally appropriate educational materials to engage and inform communities that have not been well represented in clinical trials.

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We developed this brochure together with members of Asian communities, as well as subject matter experts who have experience working with these communities. This included receiving feedback from 500 members of the Asian community through an anonymous survey.

They all helped make sure the topics, language, images, and design are appropriate and engaging. We also received feedback on how effective our brochure was for raising awareness about the importance of Asian participation in clinical research.

This process allowed us to confirm that we are addressing the key concerns and barriers that prevent better diversity, equity, and inclusion in clinical research. This brochure was also reviewed by an Institutional Review Board (IRB), which is also known as an independent ethics committee. The IRB review ensures the brochure follows ethical guidelines for providing information about clinical research to patients and the public.

Topics include:

  • Why are Clinical Trials Important?
  • The Need for Diverse Participants in Clinical Trials
  • Why Asian Communities Have Not Been Represented in Clinical Trials?
  • How Asian Participants are Protected
  • Things to Consider Before Volunteering
  • Different Ways to Get Involved

How CISCRP Made Tools for Informed Decision Making

Guiding Informed Decisions

It’s an all too familiar story – a patient receives a new diagnosis of a rare disorder. But now, they are told that there is a clinical trial option available. However, their lack of knowledge about clinical trials concerns them. In another case, a pediatric patient receives a new diagnosis and is offered an opportunity to participate in a clinical trial. Similarly in this case, the parents or caregivers of this child are not familiar with clinical trials. An important decision needs to be made in both scenarios.

Unlike the scenarios described above, most Americans have never faced a personal decision about whether to participate in a clinical trial. Of those who are invited, less than half choose to participate. There can be many reasons for this; the choice to participate or not is deeply personal. It means thinking about things like finances, family, current and past social injustices, and values, among other things.

Well before the need arises to access trial treatments, people should learn about the clinical research process, how to partner with researchers generally, and what it means to participate in trials. Even after learning about trials by reading brochures, and watching videos for adults or children, the process of making a decision may remain unclear. Making this kind of “informed decision” — one that looks at a complex decision from all angles — is hard under the best circumstances. When the choice involves personal health, or the health of a loved one, it can feel overwhelming. So, the team at CISCRP has developed brochures to address questions about clinical research and help guide the decisions of potential clinical trial participants. More examples of stories and articles can be found here, here, here, here, and here.

Developing the Brochures

CISCRP’s Health Literacy Team thought a lot about what goes into the decision to take part in a clinical trial — and what tools can help make the decision process easier — when we developed 2 new educational brochures on the topic.

The first brochure, titled “Should I Participate in a Clinical Trial?”, is for people weighing the pros and cons of taking part in a clinical trial. It includes questions that people may want to consider asking themselves, a healthcare professional, and trusted family and friends before making a decision. The brochure also serves as a resource for healthcare providers, community and faith leaders, family members, and anyone else helping potential trial participants navigate this process.

The second brochure, titled “Should My Child Participate in a Clinical Trial?”, is designed to help parents and caregivers of children who have been asked to join a pediatric clinical trial. As we wrote in a recent blog post, children have different healthcare needs and rights than adults, including different rights to make medical decisions. Parents and caregivers are tasked with making big decisions (like ones about trial participation) on their child’s behalf. Sometimes, a child might agree to join a clinical trial, but a parent or caregiver is still undecided. This means having to consider multiple perspectives at once.

The Importance of Empowering Patients as Health Literacy Professionals

As health literacy professionals, our goal with both projects was to improve the ability of individuals to find, understand, and use information and services to make health-related decisions. We emphasize this point because all materials we create, including these brochures, are planned with care to be non-promotional and unbiased. The brochures share user-friendly information to help participants, potential participants, and the public make the decisions that are best for them, and that benefit everyone and help improve the research process.

In these brochures, we aimed to address the unanswered questions people may have: What does it mean to be in a clinical trial? What does it mean to “weigh risks and benefits”? And how can I make sense of all the information coming my way?

Providing cognitive tools and points to consider helps guide the decision-making process, making it a more empowering and less overwhelming process. Additionally, we worked with patients, advocates, and subject matter experts (SMEs), who reviewed and provided input on both brochures. This helped us ensure the appropriate information and tools were included.

Conclusion

Our hope with these educational brochures is to not only empower patients or caregivers to make informed decisions, but also encourage providers and study teams to start open conversations with potential participants to help make decisions. And, we welcome conversations about other tools and information that could help patients during the clinical research process. How else can we empower patients and the public to make more informed decisions and partner with the research community to improve clinical trials?

References:

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2784556

https://hints.cancer.gov/docs/Briefs/HINTS_Brief_48.pdf

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3565180/

https://www.sciencedirect.com/science/article/abs/pii/S0738399198000603

https://www.pharmacytimes.com/view/final-analysis-of-monarch-2-trial-results-confirms-overall-survival-endpoint

Improving Accessibility in Clinical Trials

In April 2022, FDA issued draft guidance for the clinical trials industry entitled, “Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials.” Over the years, FDA has issued numerous recommendations to improve the racial and ethnic diversity in clinical trials with the goal of ensuring that clinical trials are representative of and generalizable to the larger population. As a result, companies seeking marketing approval will be required to submit a diversity plan. To meet these requirements, companies will need to articulate their demographic goals for patients recruited, explain their rationale, and provide an action plan for how these goals will be accomplished.

Even though minorities make up nearly 40% of the population of the United States,
participants of color, women, LGBTQ+ individuals, and the elderly have been historically underrepresented in clinical research. While there is encouraging movement towards the democratization of clinical trials, relatively little attention has been paid to the need to make clinical trials more accessible. This is critically important for the nearly 60 million adults in the US living with one or more visual, auditory, cognitive, communicative, physical, or emotional limitations, many of whom are already part of the 40% referenced above.

Built environments, i.e., the material and cultural world that surrounds us, determines our ability to navigate the world, and, you guessed it, participate in clinical trials. If the design of a clinical trial does not consider how the built environment impacts potential participants, it effectively prematurely excludes potential participants. It also sends a clear message that this population is not considered an equally deserving benefactor of clinical research.

Some might suggest that improved accessibility of clinical trials is a luxury instead of a necessity. The reality is that any dataset that is not representative of a diverse population is not as scientifically accurate as it would be if it included the demographics excluded. A reasonable solution, then, starts with addressing very tangible barriers through purposefully designing inclusive trials and considering how every aspect of a trial impacts a participant.

Let’s look at a few concrete examples of how we inadvertently make clinical trials less accessible:

  •  Example A: A visually impaired adult is living in a mid-sized city with limited public transportation options. They’re unable to drive, and light rail and rideshare aren’t options. So, in order to participate in a study, they’ll need to ask a friend or loved one to take off work to drive them to and from their study visit.
  • Example B: A young adult with Duchenne Muscular Dystrophy, a condition characterized by progressive muscle degeneration and weakness, has expressed interest in participating in a clinical trial. To complete the informed consent, they’re asked to provide a wet ink signature.
  • Example C: A geriatric adult with multiple sclerosis is returning to their clinical trial site for a follow up visit. Though they’re able to drive, mobility is an issue and they’re often confined to a wheelchair. The parking lot at the trial site has relatively few handicapped spots and the doors to the building do not have a push-button access switch.

Though there have been recent developments with respect to bringing clinical trials to a participant’s home through home health visits and telemedicine, there’s still plenty of room for improvement. Here are some simple strategies we can employ to make clinical trials accessible to a wider population:

  • Strategy A: Talk with the patient population intended to benefit from a clinical trial. Get to understand their unmet needs, what impacts their quality of life, and their preferences. Be thoughtful when designing your clinical trial protocol. For example, don’t simply provide transportation to and from a clinical trial site for someone with vision or mobility challenges. Make sure they have support along their journey. This includes transportation from their home to the waiting room at the clinical trial site and back.
  • Strategy B: When asking patients to complete a task, be sure you understand what is and is not feasible. When requiring a wet ink signature, consider whether a patient is able to grip a pen. Do they have a printer, ink, and scanner at home to print, sign, and return? If not, are you asking someone to travel to a copy shop when the task could more easily be completed with the assistance of technology like electronic consent (eConsent)?
  • Strategy C: Have clinical research associates (CRAs) evaluate clinical trial site accessibility. Are there curb cut outs from the parking lot to the sidewalk? Is there a touch-free means of opening the door? Is the clinical trial site located in a three-story walk up?
  • Strategy D: Are all the visits required to be on-site? Is there flexibility in when and where participants can complete study activities in case they are in pain, do not have reliable support, or have an emergency that is unavoidable?
  • Strategy E: Have conversations with each participant prior to visits about any sensory or communication strategies that work best for them and their support system.

We can reduce barriers and burdens to participation through intentional consideration of the realities faced by patients, thereby making research accessible to a broader patient population. Not only does this contribute to more equitable science, it also benefits everyone, as it pushes the industry to make less assumptions about capabilities and provide more flexibility to potential participants as a whole.

Written by Richie Kahn, Co-Founder & Principal at Canary Advisors and Kristy Birchard, Director, Canary Advisors

Additional Resources:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-plans-improve-enrollment-participants-underrepresented-racial-and-ethnic-populations

https://www.nature.com/articles/d41586-023-00469-4

To search for medical conditions in a specific location, visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

Volunteer opportunities with CISCRP, visit our Volunteer page.

Clinical Research Participation for LGBTQ+ Communities

CISCRP is committed to providing clear, unbiased, and culturally appropriate educational materials to engage and inform communities that have not been well represented in clinical trials.

English
View Brochure | Print Friendly PDF

Purchase Single/Quantity Brochures at our Store

Visit Store

We developed this brochure together with members of the LGBTQ+ community, as well as subject matter experts who have experience working with these communities. This included receiving feedback from 500 members of the LGBTQ+ community through an anonymous survey.

They all helped make sure the topics, language, images, and design are appropriate and engaging. We also received feedback on how effective our brochure was for raising awareness about the importance of LGBTQ+ participation in clinical research.

This process allowed us to confirm that we are addressing the key concerns and barriers that prevent better diversity, equity, and inclusion in clinical research. This brochure was also reviewed by an Institutional Review Board (IRB), which is also known as an independent ethics committee. The IRB review ensures the brochure follows ethical guidelines for providing information about clinical research to patients and the public.

Topics include:

  • Why are Clinical Trials Important?
  • Why LGBTQ+ Volunteers are Needed
  • How LGBTQ+ Participants are Protected
  • Things to Consider Before Volunteering
  • Questions to Ask Before Participating in a Clinical Research Project
  • Learn More About Clinical Research

Medical Hero Spotlight: Katie Doble & Her Caregivers: Facing Ocular Melanoma

katie doble medical hero spotlight
Diagnosed with Ocular Melanoma

In 2013, Katie Doble visited her ophthalmologist after experiencing vision issues in her left eye. She was immediately referred to a retina specialist who diagnosed her with ocular melanoma. Thankfully, a full body scan revealed the cancer was nowhere else in her body. Katie underwent a week of radiation plaque therapy to treat the tumor inside her eyeball, which resulted in permanent loss of vision in that eye. During treatment, her doctors biopsied her cells and categorized her cancer as stage 1A, meaning she had less than a 2% chance of metastases. Still, it was recommended she have biannual liver ultrasounds and chest x-rays in case her cancer spread.

Two days before Thanksgiving the following year, at 32 years old, Katie’s ultrasound showed multiple tumors in her liver.

“On Thanksgiving morning, my dad flew to Denver so he could be with me the following day at the liver biopsy that would confirm my diagnosis. Nick, my boyfriend at the time, had been planning to propose to me that day and was warned by family members he might want to hold off because of my diagnosis,” Katie recalls. “I found out later that he told them my cancer changed nothing; I was still the girl he wanted to marry and support. I won the husband lottery.”

On Thanksgiving Day, Nick and Katie got engaged. The following day, a biopsy of her liver confirmed Katie’s ocular melanoma had metastasized. “This would have been a difficult diagnosis for anyone, but the news hit my family particularly hard because my mom passed away from pancreatic cancer when I was 15,” Katie says.

Starting Treatment: Clinical Trials

The oncologist who diagnosed Katie advised against clinical trials claiming they would be very expensive. The one treatment option available by the FDA would have bought Katie 16 months of life. 

“After meeting with that oncologist, my dad got on the phone with doctors across the country, looking for specialists,” Katie says. Her father, Dr. Jim Ortman, presented Katie’s case to the tumor board at his hospital and was referred by a doctor to Memorial Sloan Kettering Cancer Center in NYC, where a couple of clinical trials for ocular melanoma were taking place. In early 2015, Katie enrolled in her first clinical trial in New York for a medication called trametinib.

During her treatment, Katie’s family developed a schedule where they made sure someone was always with her for scans or appointments. “It was important to figure out how to support me without overburdening one member of the family,” Katie says. When able, Katie’s siblings attended appointments, as well as Nick and Dr. Ortman. In the five weeks she was required to stay in New York for treatment, she had nine visitors.

Six months after starting treatment, scans revealed growth and Katie was moved to the second arm of the trial, adding another drug. Additional growth in the following scan two months later eliminated Katie from the trial completely. However, the Doble family wasn’t discouraged.

“In 2014, I went from no tumors to 12 tumors in the span of six months. Taking trametinib didn’t shrink my tumors, but it did buy us more time,” Katie notes.

With cancer, it’s important as a patient and caregiver to develop a plan with your doctors for the next steps should your current treatment not be effective. While Katie was in New York, Dr. Ortman was working behind-the-scenes with her doctors to understand treatment options going forward.

After her first clinical trial, Katie was excited to get a break in treatment and worked to regain some of the 30 pounds she had lost. Shortly after returning to Denver, she enrolled in a second study at UCHealth in Colorado but was quickly removed from the trial when the side effects were too intense. It was determined the doctors would perform a targeted radioembolization on half of her liver, leaving the other half untreated as a baseline so they could see how future systemic treatments were working. A third clinical trial, also at UCHealth, was short-lived and the other half of Katie’s liver was embolized. The embolization stabilized Katie’s liver for 3.5 years.

In 2018, Katie’s treatment journey continued when she presented with stroke-like symptoms. Although never confirmed by biopsy, her doctors suspected a brain tumor. Katie underwent a Gamma Knife procedure, which was successful. Then, in 2020, Katie experienced a major recurrence with tumors in her liver.

Katie’s doctors recommended she start TIL therapy at UPMC in Pittsburgh. Although TIL therapy is seen by many as a relatively new treatment, it has been developed and improved over the last several decades. In fact, Dr. Ortman recalls that his late wife was slated to start what he believed to be an early version of TIL therapy before she passed away. Nearly 25 years later, the same treatment would save Katie’s life.

“For me, TIL therapy was incredibly effective. Within a year, nearly all my tumors had disappeared or shrunk besides one, which we jokingly named Uncle Fester as my doctor referred to it as the ‘festering problem,’” Katie recalls. In 2021, Katie had major surgery to remove ½ of her liver, including ‘Uncle Fester’. Upon waking, she was told she had No Evidence of Disease (NED).

Dr. Jim Ortman, Physician & Caregiver

Since the beginning, Katie’s father, Dr. Jim Ortman, and her husband, Nick Doble, have provided unique but equally important support. As an Internist, Dr. Ortman helped research treatment options and navigate the healthcare system. As her partner, Nick provided the emotional support and the day-to-day caregiving Katie needed during treatments.

“When Katie had her liver biopsy in Colorado, the pathologist and I looked at the black tissue and I could immediately tell it was melanoma; it was devastating,” Dr. Ortman recalls.

From her initial diagnosis, Katie’s father was doing extensive research to find the best specialists and treatment options for Katie. He advocated for her to begin participating in clinical trials and helped relay any symptoms or questions she had to her care team.

As Katie and her father navigated Western medicine for ocular melanoma together, Katie’s decision to seek out complementary treatments alongside the standard medications became a point of discussion between the two.

“I started seeing a nutritionist and taking supplements and my dad was skeptical of this type of medicine,” Katie remembers. Eventually, Dr. Ortman accompanied Katie to an appointment and the two had a positive conversation about the importance of nutrition when battling cancer. “As a cancer patient, you lose control over much of your life. My nutritionist really helped improve my relationship with food during this time. From experience, I know that chemotherapy hurts. Even if the supplements weren’t helping, they ultimately weren’t hurting me and gave me back some control over my life,” Katie says.

Nick Doble, Husband & Caregiver
Nick Doble had known of Katie’s cancer since they met in 2013. “When it metastasized to her liver, there was never a thought that we should reconsider our relationship,” Nick says. “All I knew was that I wanted to be with her and support her throughout her treatment.”

Nick admits to experiencing a learning curve when it came to understanding Katie’s diagnosis and treatment options, something most loved ones feel early on when emotions are high, and they are receiving an influx of new information. Growing up in the UK, Nick notes that he was much less familiar with clinical research and how to find a trial. “I was so grateful to Jim for the research he was doing and the knowledge he already has as someone in the medical field,” Nick remembers.

As her spouse and caregiver, Nick tried to keep Katie positive during her treatments and provide what she needed most on any given day, whether that was listening, giving her space, or providing a distraction (like the time he caved when she pulled the cancer card to get a dog). During TIL therapy, Katie and Nick branded themselves “the increDOBLES.”

“There were a lot of difficult discussions Nick and I were having that couples our age don’t have to think about, including end of life care and wills,” Katie says. Katie chose to appoint both Nick and Dr. Ortman as her power of attorney so the burden would not fall on one person alone.

As a caregiver, Nick advises others in positions like his to make sure to balance your own wellness and mental health to support your loved one. “For me, exercise has been a great outlet and form of self-care,” Nick says. “It’s so important to find support whether that’s by therapy or talking to others.”

Advocacy Work & Advice

Katie was a recipient of the 2017 Courage Award at the Melanoma Research Foundation’s Wings of Hope Gala where she had her first public speaking engagement discussing her cancer. The experience motivated Katie to share her story and begin participating in other advocacy projects. Dr. Ortman and Katie shared the father/daughter – doctor/patient perspective at the Colorado Cancer Coalition in 2019. In 2021, Katie received the Outliving It Award from First Descents, a non-profit that provides the healing power of adventures to young adults and caregivers facing cancer and MS.

“I know my cancer journey is a story of hope, which I’m grateful for, but it also comes with a lot of wisdom and knowledge I can share with others because of my dad,” Katie says. “Without him and Nick, I wouldn’t be here today.”

When it comes to sharing advice about getting involved in clinical trials and navigating treatment, Katie and Dr. Ortman have a wealth of information from their experiences.

“I believe in the importance of getting a second opinion and always having a Plan B when it comes to treatment,” Katie shares. “There is no room for ego from doctors when a patient is fighting for their life, it’s not personal. If it weren’t for the second opinion I got, I wouldn’t be here today.”

Dr. Ortman advises patients who may be interested in joining a clinical trial to speak with their care team or oncologist to see if they are eligible or if they have any recommendations.

Additional Resources:

https://www.ocularmelanoma.org/basics-of-om
https://futurehappyself.com/
https://melanoma.org/
https://clinicaltrials.gov/

To search for medical conditions in a specific location, visit our Search Clinical Trials page.

To stay informed about clinical trials, visit our Resources page.

For volunteer opportunities with CISCRP, visit our Volunteer page.

Written by Lindsey Elliott, Marketing & Communications Manager, CISCRP | lelliott@ciscrp.org