AWARE for All Fall Updates

Written by: Hope Ventricelli | hventricelli@ciscrp.org

At the beginning of 2020, the CISCRP Events team had their work cut out. We had to adapt our live educational event (AWARE for All) model to a completely virtual program while remaining accessible to the patient and public communities. And, we had to do so while affording CISCRP the opportunity to engage the public in a new and meaningful way.

AWARE for All-Southwest will be a live webinar stream via the virtual platform on October 21. With it, we aim to continue spreading awareness about the essential role that trial participants play in clinical research and how the research community can engage them as partners in the clinical research process.

Unlike our previous AWARE webinars, AWARE for All-Southwest will be condensed to just one hour and focus heavily on the panel discussion—a favorite segment among audience members. This discussion between trial participants, researchers, and industry stakeholders will give attendees a well-rounded view of the clinical trials process from varying perspectives.

Diversity and inclusion is at the heart of all the AWARE For All events. The importance of representation in healthcare is pivotal to comprehensive treatments, and the need is often misunderstood by the public.

“People can experience differences in response to a treatment as well as different side effects,” explains Dr. Lok, who participated in the recent Midwest panel. “This is why clinical trials need people from all communities representing all stages of a disease to find an effective treatment.”

As part of these efforts, CISCRP collaborated with trial volunteers and researchers to share their unique experiences with clinical research to help the audience better understand the importance of participation. As Desiree De-Luca-Johnson, a Breast Cancer Trial patient, shared at a recent event, “I felt safer in a clinical trial because I had a better relationship with my research oncologist and oncology nurse in Boston. I was able to feel safe for a year—it gave me some time to breathe and research my options.”

At the end of this summer, the events team was hoping to be in person for the final program of the season. CISCRP selected Atlanta for our first face-to-face event since 2019 due to the robust clinical research community, demographic diversity, and already established connection with the city. However, due to the Delta variant and public safety concerns, we have decided to remain virtual and proceed with an Atlanta-based event. Keeping virtual fatigue in mind we look forward to developing a fresh take on the webinar for  AWARE for All – Atlanta with local involvement and an exciting new agenda.

This flagship CISCRP initiative is a longstanding, internationally recognized program with a goal to address health disparities and low levels of clinical research literacy. Since 2003, CISCRP has been developing elements of the AWARE for All program to keep up with current health concerns and community needs while maintaining the need for diversity in research. Be sure to follow us for the latest updates on both programs and local opportunities to be involved.

To learn more about supporting as a sponsor, participating as a speaker or exhibitor, please email Hope Ventricelli, Manager of Events and Community Engagement, at hventricelli@ciscp.org.

 

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CISCRP’s Newly Launched Educational Brochure Initiative

Written by: Makenzie Michel | mmichel@ciscrp.org

At CISCRP’s Health Communications Services team, we develop educational materials to engage and empower patients and the public, including communities that are typically underrepresented in clinical trials. As an independent, non-profit organization, our unbiased deliverables are non-promotional. We offer many of these materials (which can be found in our online Education Center) free of charge to the public and patients.

Our materials are written in easy-to-understand language—sometimes referred to as “lay” or “plain” language—to ensure that we are communicating complex issues in simple terms. We also write our content to be engaging and culturally appropriate, and to address the key concerns of the audiences we hope to reach. Using strategic graphic design, we reinforce key messages through careful use of layout, colors, icons, images, charts, and other graphics.

Since being founded in 2003, we have developed brochures and other materials about the critical role of clinical research and trial participants in public health. One of our long-standing goals has been to reach communities that have been underrepresented in clinical trials. During our brochure reevaluation this year, we have collaborated with key stakeholders and community members to get significant input from these people we hope to reach. With the increased awareness and greater emphasis on social and health equity, we are focusing on connecting with underrepresented communities to make sure we appropriately address the concerns and barriers they face.

We are continuously partnering with medical writers, subject matter experts, and community members. We believe that this method of co-development will allow for the most educational and highest quality content. An editorial panel of patients, public, and professional representatives reviews each deliverable and provides their feedback before we finalize any publication. Additionally, we utilize Feedback Forums to acquire more detailed information about certain topics. In these forums, we speak directly with members of the communities we hope to reach and/or those who have expertise in communicating and working with those communities. They help to ensure the materials are effective, easy-to-understand, unbiased, and culturally appropriate. As always, all CISCRP educational materials are reviewed and approved by an IRB (Institutional Review Board), and are available in multiple languages.

Research professionals, sponsors, and other members of the clinical research community are able to license and co-brand these updated materials. Our brochures can be used by research centers, academic institutions, pharmaceutical companies, health care professionals, and advocacy groups to provide education about clinical research and clinical trial participation.

Keep an eye out for upcoming newly launched educational brochures!  

Visit CISCRP’s Education Center for more information about the newest brochures, to learn about the topics we are working on, and to share ideas that help close other gaps in clinical research.

As we continue to update our portfolio of educational materials, please reach out to Joan Chambers at jchambers@ciscrp.org to discuss purchasing and licensing opportunities. You can also visit CISCRP’s online store to purchase these deliverables.

 

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Medical Hero Spotlight: Rev. Donna J. Matlach & Eosinophilic Asthma

“My sister Roseanne and and I love the movie, ‘The Wizard of Oz’. I told Roseanne I felt like I was going to see the Wizard. There was so much that happened before I got to see her, just like a lot happened to Dorothy in the movie, recounts Reverend Donna J. Matlach, about meeting Dr. Sally Wenzel of the University of Pittsburg Medical Center to consult about Donna’s severe eosinophilic asthma. My granddaughter, Phoebe, even said ‘Nana is going to see the wizard!'” Donna’s medical journey has been arduous and at times, terrifying, (Donna has had severe eosinophilic asthma for more than a decade) but her upbeat nature shines through during our conversation about her experience with clinical research participation.

“It can’t be controlled with the typical medications that are used with other types of asthma. It’s another level of asthma – it goes up in levels. Mine is severe, which is the highest level. It took many years to figure out why it couldn’t be controlled,” explains Donna. “I was in and out of the hospital, 3 to 4 times a year, and in the doctor’s office 3 to 4 times per month. I was on mass quantities of corticosteroids taken orally and by inhalation.” The steroids impacted her overall health, including weight gain and brittle bones leading to several fractures.

The severity of her symptoms sapped Donna of her physical strength, but not her inner fortitude. Taking matters decidedly into her own hands, Donna went on a cross-country journey in order to find medical advice and effective treatment. Conducting a lot of research on her own, Donna visited 28 doctors, the majority being pulmonary specialists, in 12 hospitals, nationwide. In a frustrating turn of events, they all provided different diagnoses and advice. To make matters worse, the nebulizer and cortiscosteroid medications Donna was taking were not adequately controlling her illness.

“My asthma was so misdiagnosed that at one point, doctors from a major medical facility told me I should see a psychiatrist. I was on a nebulizer every hour to stop the coughing and wheezing,” says Donna. “I’ve had over 600 allergy tests. I’m not allergic to anything.” Donna continued on her quest for relief from her symptoms. Donna consulted with a physician in Colorado who recommended she meet with Dr. Wenzel.

“Dr. Wenzel is the guru. She founded the University of Pittsburgh Asthma Institute,” says Donna.

During one of her many visits to Pittsburghwith Dr Wenzel, Donna had video assisted thoracic surgery to take biopsies and view her lungs with a camera. “I woke up with a tube in my chest to prevent my lungs from collapsing. The pain was so bad I ended up having a full-blown asthma attack, even with the pain medication pump. I’ve had a lot of surgeries in my life, including two C-Sections, and this was the worst!” says Donna.

Donna has had two 6-hour surgeries on her sinuses in the past several years. Both times, her sinuses were evaluated to be 98% blocked. “I had no taste or smell for 3 years because the sinuses and asthma were impacting each other. Everything is connected,” says Donna. When Donna arrived for the first surgery, she was told her lungs were too weak to undergo the procedure. Dr. Wenzel was concerned she would not survive the anesthesia. When Donna was able to have the first sinus surgery, several months later, Dr. Wenzel advised Donna that the positive results she was experiencing would last about three years.

“Wouldn’t you know it, it was just about 3 years to the month and I needed to have another surgery. Dr. Wenzel was right – that’s why I call her The Wizard,” says Donna. The second sinus surgery removed a bone from the left and right side of Donna’s frontal sinuses.

Dr. Wenzel advised Donna to investigate participating in clinical research to find other ways to manage her asthma. Dr. Wenzel assisted her with this process, but Donna was told she was not sick enough to participate in the first clinical trial to which she applied. This was perplexing to Donna because, she recounts that “I have been catching pneumonia twice year!”.

Dr. Wenzel located another clinical trial and Donna qualified as a participant. The clinical trial site was in California.

“I flew from my home in Arizona to California, once a month, at my own cost, for three years. I ended up being a poster child for the sponsoring company. I now speak at lectures for them about my experience, in New York City and other places,” says Donna.

The medication she received in the clinical trial in California was not immediately effective. “It took about 6 months to get into your system. At first it was an IV medication, and then it became an injectable,” says Donna. “My asthma is like a firecracker. It will either fizzle out or it will explode.” A couple of years later, that treatment stopped working.

During this time, Donna’s health was also being monitored in her then-home-state of Arizona. “I was at the Mayo Clinic in Scottsdale, waiting for a lung function test, and while I was there, I had a severe asthma attack. It came out of the clear blue sky. I ended up in the ER. God put me in a place where I could be helped and I wasn’t alone. I’ve had three near fatal episodes because of the asthma,” Donna recalls.

After the clinical trial that Donna participated in, Dr. Wenzel prescribed a biologic that had recently come to market. “It took 4 months for it to start working and I took it for a year. But I was still back and forth with ER visits that always turned into a hospital stay, unfortunately,” says Donna.

During her hospital stays, Donna continued to work on her studies towards her Masters of Divinity. Even though she was very ill, Donna says that “God told me… You’re not done.” She subsequently studied several more years and received her Doctorate in Ministry and Master’s in life coaching.

Dr. Wenzel then prescribed a third biologic medication, which was not part of a clinical trial.

“I go to Pittsburgh twice a year to see Dr. Wenzel and we’ve become close friends. I love her. My heart told me, when I met her, that this was going to be the best doctor I could possibly see,” says Donna, smiling.

Donna’s family was supportive of her decision to join a clinical trial. She looked for patient advocacy organizations for severe asthma, and there were none established at that time. In response, Donna co-founded the Severe Asthma Foundation with Dr. Wenzel and Brenda, another severe asthma patient of Dr Wenzel’s.  Donna served as president until they were subsequently invited to merge with the Allergy and Asthma Network where Donna serves on the Board of Directors as an asthma advocate.

Donna has experienced, first-hand, the serious impacts of severe asthma. “It’s not just physical. It effects your emotional well-being. It effects your family, your day-to-day life, your finances. No one ever asked me about those things, in doctor’s appointments – not until I met Dr. Wenzel,” says Donna.

When asked if she would recommend clinical research participation to others, Donna enthusiastically responds “Absolutely. It can be life saving. Why would you not? You could have side effects, but for me, how could it be any worse, since I was having near fatal episodes? You have to keep searching. Clinical trials can be the answer. Why would you not want to try it? This is why I am a patient advocate. I love sharing information about clinical trials with people. That’s why I went into the ministry. I know God has a purpose for my life to reach out to people with similar physical issues as a friend, minister, and counselor. ”

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.

 

AWARE for All – Midwest Event Overview

On July 22nd, attendees logged on to view the AWARE for All – Midwest virtual event. The third event in a sequence of five running throughout 2021, AWARE for All – Midwest aimed to break down the clinical trial process, share a variety of perspectives from trial participants and healthcare professionals, and answer common questions and misconceptions many have about clinical trials.

The event started with an overview presentation about how clinical trials work and the important role trial participants play in the process. The presentation was led by Steve Satek, Founder & President at Great Lakes Clinical Trials, who explained the importance of informed consent, how to decide if a clinical trial is right for you, and why clinical research is so important to the advancement of medicine.

As Steve noted, “It could have been five, ten, or even twenty years ago that people chose to participate in clinical trials that paved the way for the medication you take today.”

The next segment of the webinar featured a panel discussion, led by a group of clinical trial participants and healthcare professionals who shared their stories and perspectives. Among the clinical trial participants were Nia Grant, a Type 1 Diabetes trial participant, Lynne Jordan, a talented performer and COVID-19 vaccine trial participant, and Dorie Rivera, a mother, caregiver, and rare disease advocate.

There are many different reasons someone might choose to join a clinical trial. For Nia, participating in clinical research gave her a chance to represent her community and ensure diverse populations were included. Nia said, “Representation in research is important. If there are no trial participants who look like me, how can a doctor be sure a treatment is effective?”

For Lynne, joining a clinical trial gave her the chance to be a part of the effort to tackle the COVID-19 public health crisis, making a difference for her community and around the world. As Lynne recalled, “As a member of a community disproportionately affected by COVID-19, I wanted to be a part of the solution to this crisis.”

For Dorie, enrolling her daughter in a clinical trial gave her access to new treatments and gave her family the hope they needed. After being referred by other parents, Dorie decided to give the trial a try, stating “It was either joining a trial or facing complete hopelessness.”

The AWARE – Midwest panel discussion also featured several healthcare professionals who shared their experiences, including Dr. Anna Lok, Holly Milaeger, MPH, and Dr. Manish Jain. Together, the panelists tackled issues related to clinical trials such as the importance of diversity, how barriers to participation can be overcome, and the best ways to educate and inform about clinical trials, starting at a community level.

After the webinar concluded, viewers were able to navigate to the Informational Exhibit Center, a virtual exhibit hall that offers resources and information from over 40 health and wellness organizations in the Midwest region and across the country. A quick ‘click’ connects visitors with local advocacy organizations like Latino Union of Chicago, Indigenous Peoples Task Force, and The Chrysalis Initiative. The Informational Exhibit Center also features a Health and Wellness Pavilion where visitors can watch health exercises and tips, and a theater with short educational videos about clinical trials.

If you missed the AWARE for All – Midwest event or would like to tune in again, the recorded webinar and Informational Exhibit Center remain accessible here.

View more 2021 AWARE for All events here.

Women in Clinical Trials

From “The Gift of Participation” by Ken Getz, Founder & Board Chair, CISCRP

Gender mix in clinical trials, overall, appears to be relatively balanced. Research conducted by the Center for the Study of Drug Development at the Tufts University School of Medicine found that, in clinical trials conducted in support of drugs submitted to the FDA, 52% of all patients who participated were men and 48% were women.

There is no question, however, that protocol designs have historically addressed disease as it manifests in adult males. Beginning in the early 1990s, public pressures fueled stricter government requirements for the presentation of data by gender in market applications to the FDA and valid analysis by gender at the NIH. In 2000, the FDA further specified that a clinical trial excluding persons having reproductive potential could be placed “on hold,” preventing further product development. This requirement helped ensure that women of childbearing potential were included in studies.

Pharmaceutical and biotechnology companies have also sought ways to increase the market potential for new and existing drugs by gathering clinical data to make specific claims about drug safety and effectiveness among women. As a result, clinical trials are increasingly being designed to assess the safety and efficacy of gender-specific medical treatment, and medical treatments are being “personalized” for gender differences in response.

Many diseases behave differently in women than in men. Risk factors, symptoms, the clinical course, and response to treatment can all be gender-specific. Among a long list of differences, men and women vary by:

  • body size, composition, and metabolism
  • the ways their bodies change during the aging process, e.g., puberty and midlife
  • endogenous hormones
  • exogenous hormones

Due to these differences and to other factors researchers have discovered that:

  • Lung cancer kills more women than any other cancer.
  • Alzheimer’s disease is twice as prevalent in women.
  • Men and women experience pain differently.
  • Women are two to three times more likely to experience depression, due to less serotonin uptake in the brain.
  • About 75% of autoimmune diseases occur in women, most frequently during childbearing years.
  • Urinary incontinence and dysfunction are more common in women and often have an entirely different cause than the same conditions in men.
  • Cardiovascular disease kills approximately 250,000 more women each year than all forms of cancer combined, accounting for 58% of all deaths. Within a year of the first myocardial infarction, 44% of women die, compared to 27% of men. Hormone-replacement therapy does not prevent heart disease, as was previously assumed.
  • The initial HIV viral load may be significantly lower in women, who represent an estimated 30% of new infections, but both sexes develop AIDS at the same rate

Although the FDA recommended in 1993 that clinical studies include enough women to understand the unique ways in which their bodies respond to drugs, women are still underrepresented in small, phase I trials. And when eligibility is restricted by age, older women are disproportionately excluded from studies of diseases that are more common in women at older ages. Although regulations prohibit the explicit exclusion of women of childbearing potential, the possibility of becoming pregnant can result in women in their childbearing years not being included in studies.

Generally, a woman capable of conceiving a child won’t be considered for a clinical trial unless she’s not pregnant and agrees to use birth control. Some studies require that women of childbearing age use two forms of contraception to participate in a study. Pharmaceutical companies don’t want their drugs tested among women who are—or might get—pregnant, mostly because the risk of exposure or a lawsuit by the mother is too high. Even in normal pregnancies, 1% to 2% end with an abnormal birth. Many parents are quick to blame poor birth outcomes on drugs. Some doctors erroneously believe that certain drugs cause fetal abnormalities. But genes and chromosomes are the primary culprits, according to Marilynn C. Frederiksen, M.D., associate professor of obstetrics and gynecology at Northwestern University Medical School.

“All of this presents a major barrier to clinical trial participation by women who don’t want, can’t afford, or are religiously opposed to contraception,” says Frederiksen.

Things aren’t bound to change unless the NIH comes up with the funds to conduct special dosing studies in pregnant women. And that probably won’t happen quickly or easily.

The NIH has an Office of Research on Women’s Health to help strengthen policies requiring inclusion of women in clinical research and to help translate new knowledge into clinical practice, but it doesn’t have any institutes that devote research dollars specifically to female health issues. As a direct result of the 1993 NIH Revitalization Act, NIH-sponsored clinical research now routinely includes sufficient numbers of non-pregnant women. In 2001, additional protections were given to pregnant women (as well as human fetuses and neonates) that spell out the conditions under which they can be involved in federally funded research— if earlier studies provide data on the potential risks, for example, and the risk to the fetus is caused solely by interventions that could directly benefit either the women or the fetus. Participation of women in NIH-funded studies, overall, is proportional to the percentage of women in the general population when sex-specific studies are excluded.

The participation of women in clinical trials is essential. The exclusion of women from early-phase studies, in particular, delays the discovery of sex-specific dosing requirements and the identification of gender-specific side effects, limiting the identification of drugs that are useful just for women. The problem is compounded by the fact that animal studies, when scientists learn about many of a drug’s potential adverse reactions, also tend to exclude females. Limiting studies to a single gender requires fewer study subjects (animal or human) and, thus, shorter and less costly studies.

There are many hopeful signs of change. Pharmaceutical companies are devoting a tremendous amount of money to trials focusing on diseases and conditions that only affect women.

For more information on clinical trials and making informed decisions about volunteering for clinical research, read “The Gift of Participation” by Ken Getz, Founder and Board Chair, CISCRP.

You can find the book here.

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.

Clinical Trials: Improving Patient & Physician Education

CISCRP Perceptions & Insight Study Data Cited in Clinical Leader

A large and diverse pool of clinical trial participants scales the successful development of medications, therapies and treatments. Making trustworthy information about clinical research readily available to the public and physicians can serve to reduce mistrust of clinical studies. Clinical Leader addresses this topic in an article titled “3 Key Ways to Improve Patient & Physician Education on Clinical Trials”, citing data from CISCRP’s Perceptions & Insights Study. You can learn more about clinical research here.

CISCRP & Partners’ PLSP on Breast Cancer Study Published in Future Oncology

CISCRP (Center for Information and Study on Clinical Research Participation) and Oxford PharmaGenesis worked together with Daiichi Sankyo, AstraZeneca and Dr. Shanu Modi of Memorial Sloan Kettering Cancer Center in New York to write a plain language summary publication (PLSP) of the results of the DESTINY-Breast01 clinical study.

The participants in the study received a treatment called trastuzumab deruxtecan, also known as T-DXd. T-DXd consists of a chemotherapy drug linked to a manmade antibody. The antibody in T-DXd is a protein that specifically targets and attaches to the HER2 protein on tumor cells.

The PLSP was recently published in Future Oncology with the title “Trastuzumab Deruxtecan in Previously Treated HER2-Positive Metastatic Breast Cancer: Plain Language Summary of the DESTINY-Breast01 Study”. View the article here.

Why Clinical Trials Are Conducted

From “The Gift of Participation” by Ken Getz, Founder & Board Chair, CISCRP

Close up of African American physician listening to heart and lungs of patient

People want and expect their doctors to use treatments that work well and to stop using those that do not. Long ago, trial and error was the primary way that physicians and medical care providers learned how to recognize treatment alternatives. Later, through rigorous approaches that use clinical trials, physicians and researchers were able to gather far more meaningful information about diseases and how best to treat them.

For thousands of years, healers, shamans, and medical care providers have been administering treatments and remedies. One of the earliest known medical treatments dates back more than 3,500 years to ancient Egypt. Some ancient remedies, such as those used for simple fractures and minor injuries, are effective even today. However, many ancient medical treatments did not work and were actually harmful and even fatal. Two hundred years ago, cutting open a vein to drain a pint or more of blood and giving toxic substances to force vomiting or diarrhea were common remedies. And only a century ago, along with mention of some useful drugs such as aspirin and digitalis, the Merck Manual— one of the most respected sources for information on medical treatments then as well as now mentioned cocaine as a treatment for alcoholism; arsenic and tobacco smoke as treatments for asthma; and sulfuric acid nasal spray as a treatment for the common cold. Today these approaches are known to be very dangerous.

There are many reasons that doctors recommended ineffective and harmful treatments and that people accepted them. In many cases there were no alternatives. Doctors and patients usually prefer doing something to doing nothing. Patients also find comfort in sharing their problems and ailments with an authority figure. And doctors feel compelled to provide attention, support, and reassurance.

The primary reason doctors recommended ineffective and harmful treatments is that doctors couldn’t tell what worked from what didn’t. Doctors relied on cause-and-effect to identify potential treatments. For example, if an ill person’s fever broke after the doctor drained a pint of blood or after the shaman chanted a certain spell, then people naturally assumed those actions must have been what caused the fever to break. To the person desperately seeking relief, getting better was all the proof necessary. Unfortunately, these apparent causal relationships observed in early medicine were rarely correct. Still, they were enough to promulgate centuries of ineffective remedies. Of course, people had to be getting better in order to reassure doctors that a given treatment was working. Indeed, this is exactly what often happens. People do get better spontaneously. Sick people often get well on their own—and despite their doctor’s care—when the body heals itself or the disease runs its course. Colds are gone in a week; stomach flu passes within hours; migraine headaches typically last a day or two; and food poisoning symptoms may end in 12 hours. Many people even recover from life-threatening disorders, such as a heart attack or pneumonia, without treatment. Symptoms of chronic diseases (such as asthma or sickle-cell disease) come and go. Many treatments may seem to be effective if given enough time. And any treatment given near the time of spontaneous recovery may seem dramatically effective.

Belief in the power of a treatment or remedy is often enough to make people feel better. Belief cannot cause an underlying disorder—such as a broken bone, heart disease, or diabetes—to disappear. But people who believe they are receiving a strong, effective treatment very often feel better. Pain, nausea, fatigue, and many other symptoms can diminish. This happens even when the drug contains no active ingredients and can be of no possible benefit, such as a sugar pill or an inactive substance called a placebo. An ineffective (or even harmful) treatment prescribed by a confident doctor to a trusting, hopeful person often results in remarkable improvement of symptoms. This improvement is termed the placebo effect. People may see an actual (not simply misperceived) benefit from a treatment that has no real effect on the disease itself.

Some people argue that the only matter of importance is whether a treatment or remedy makes people feel better. Whether it works or not is of little consequence. This argument may be reasonable when the symptom is the problem, such as in many day-to-day aches and pains, or in illnesses such as colds, which always go away on their own. In such cases, doctors do sometimes prescribe treatments for their placebo effect. However, in any dangerous or potentially serious disorder, or when the treatment itself may cause side effects, it is critically important for doctors not to miss an opportunity to prescribe a treatment that really does work.

For more information on clinical trials and making informed decisions about volunteering for clinical research, read “The Gift of Participation” by Ken Getz, Founder and Board Chair, CISCRP.

You can find the book here.

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.

Medical Hero Spotlight: Desiree De Luca-Johnson & Breast Cancer

“I am a lawyer, my husband is a pathologist, and I had no idea that there were hospitals that just treated cancer,” says Desiree De Luca-Johnson, an attorney, breast cancer survivor and patient advocate. At the age of 40, just when she was ready to go back to work after staying home with her young children, Desiree was diagnosed with breast cancer. Desiree’s road to being a clinical trial participant is reflective of her legal training. “I made a plan. I had a white board. I decided that if ‘A’ happens, then we would move on to ‘B’. I’m passionate about clinical trials.”

Desiree was diagnosed while living in a military community in Virginia, and her husband was deployed. “I was exhausted, and literally crawling upstairs to put my kids to bed,” Desiree recalls. Her oncologist at the time was a military physician and the treatment plan recommended for Desiree was conservative in nature. She was not told about clinical research as a healthcare option.

“I got 200 pages of where I could get free makeup and wigs, and not one page on clinical trials,” says Desiree. “I discovered that oncologists have different attitudes about treating cancer and I wish someone had told me about this. My oncologist was not aggressive about different treatment options.” Desiree recalls she was willing to deal with a higher level of side effects when her doctor told her she had an 80%/20% chance of survival.

“I was suicidal because of the anxiety. I found out (in addition to the breast cancer), I had a benign brain tumor,” says Desiree.

When she posed a question about clinical trials, Desiree’s doctor told her she was not sick enough to be in a clinical trial.

Desiree’s background as an attorney had honed her research and investigative skills. She decided to take definitive action.

“I made lists of cancer hospitals. I investigated their websites. I learned about ClinicalTrials.gov, which is a hard website to navigate. My husband was opposed to me doing a clinical trial, so I was doing this research all alone. But it was keeping me alive,” says Desiree. (Desiree’s husband ultimately embraced her decision to participate in clinical trials). “After 40 or 50 hours of work, I found BreastCancerTrials.org, where I found 6 clinical trials I might be eligible for. We have a saying in the law. When you’re repeating your results, you have done your research. I was ready to apply to clinical trials,” says Desiree.

Her oncologist in Virginia was not supportive of Desiree’s decision, and voiced a level of concern about clinical trial participation. Undeterred, Desiree pursued clinical research options and other avenues for her health and wellness.

“The most important thing about choosing to enroll in a clinical trial, for me, were childcare and the affiliated travel costs,” says Desiree. “I became my own doctor, in a sense. I read that doing yoga was good when you have cancer, so I did yoga. I read that exercise was good, so I hired a health coach,” says Desiree.

And, she participated in clinical trials. “I did an early-stage trial,” says Desiree. “The big barrier, again, was childcare. The navy has a program so my husband didn’t have to deploy during my treatment, so he could take care of our children.”

Desiree’s sister, who lives in Boston, recommended looking at Massachusetts General Hospital for relevant clinical trials to join. Desiree enrolled in a one-year treatment clinical trial. At the end of this clinical study, it was deemed a negative trial, meaning that the results demonstrated that the new treatment was inferior to standard treatment. (1) Overall, the experience was still a positive one for Desiree.

“I felt safer in a clinical trial because I had a better relationship with my research oncologist and oncology nurse in Boston. We were all up to date on the same research,” says Desiree. “I was grateful to be at a top research hospital. I was able to feel safe for a year – it gave me some time to breathe and research my options.”

“Through my clinical trial participation, I got access to other treatments for other conditions, such as bone density, and I was able to access other clinical trials,” says Desiree. Her research oncologist became her primary oncologist.

“Now I am in a trial to monitor for re-occurrence and I can make an action plan for quality of life,” says Desiree.

“Before participating in clinical research, every single day my first thought was, how will I know if my cancer has returned? Now I wake up and feel free,” says Desiree.

Desiree and her children have relocated to her home state of Vermont, in order to be closer to Massachusetts General Hospital, the clinical trial and family. “The relationships really matter,” says Desiree.

Desirae’s clinical research journey has brought her full circle, professionally. She currently works full-time at BreastCancerTrials.org as Outreach and Operations Manager.

Desiree advises people considering clinical research that, “When it comes to your oncologist, it’s a fiduciary relationship. It was my job to know the consequences of the decisions I was making to help them reach their goals. You have to be your own best advocate. No one is going to care as much about your life as you do.”

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.

Sources:

  1. https://www.rxlist.com/negative_clinical_trial/definition.htm)

Pros & Cons of DCTs & Virtual Clinical Trials

From "The Gift of Participation" by Ken Getz, Founder & Board Chair, CISCRP

They are known by different names: DCTs (decentralized clinical trials), remote, direct-to-patient, virtual, digital, site-less or simply patient centric clinical trials. All of these approaches share the common goal of making it easier to participate in research by reducing—or eliminating altogether—the number of study visits patients must make to conventional investigative sites or labs and allowing for more flexibility in carrying out study-related activities. Many of these approaches use smartphones, mobile devices, and wearable sensors to collect and evaluate patient data during the study.

Study volunteers often need to travel long distances to medical facilities, many need to stay overnight in a hotel, and take time off work to participate in a conventional clinical trial. Research from CISCRP shows that about one-fifth of study volunteers find clinical trial participation stressful and report the investigative site location and time-consuming study visits are among the least-liked aspects of the experience. Half of volunteers also feel that participation causes disruption to their daily routine. New, more convenient approaches are especially valuable for patients who may be too sick to travel or for those who rely on caregivers for support. Study volunteers who find it difficult to fit additional medical appointments into an already busy schedule or those who live far from the investigative site and wouldn’t otherwise be able to participate in the trial also benefit.

Not every clinical trial currently offers study volunteers an in-home or remote option, and it will take quite some time for a large number of trials to be done this way, but use of these approaches is expected to increase as pharmaceutical and biotechnology companies invest more widely in efforts to improve the clinical trial experience for patients. Research sponsors and regulators are working on initiatives that better take patient needs into account and could eventually allow patients to participate in clinical research wherever and whenever they want, whether it be their own primary-care doctor’s office, home, workplace, school, or anywhere else.

You shouldn’t feel forced to participate in a remote or at home study if you live near an investigative site and would prefer to have a face-to-face relationship with the study staff.

Pros:

  • You won’t need to travel and make frequent visits to an investigative site.
  • You’ll spend less time in a medical office.
  • You can participate in telemedicine visits at a time convenient for you, perhaps in the evening or on weekends.
  • You can contact someone on the research team 24 hours a day.
  • You may feel empowered by being able to participate whenever it is convenient to do so.

Cons:

  • You won’t have the same number of face-to-face interactions with study staff.
  • If you have a technical problem, you have to reach someone on your own to resolve the issue.
  • You’ll need to make sure you’re home to sign for clinical trial-related deliveries.
  • You may be asked to take your own vital signs or perform tests several times a day.
  • You may need to travel to a lab or medical facility for lab work or exams.
  • You may be asked to collect samples and arrange for them to be picked up.
  • You’ll likely need to send back all of the loaned devices and monitors at the end of the trial.
  • Not all wearable technologies have been validated, so you may need to repeat tests or travel to the research center for a special assessment.

When deciding whether a home-based or remote clinical trial is right for you, after you’ve learned as much as you can about the study visits and what activities you’ll need to perform on your own, discuss the pros and cons with your family, friends and primary care physician. It’s best to ask for input from people you know and trust and to involve your support network in your decision-making process.

For more information on decentralized clinical trials and making informed decisions about volunteering for clinical research, read “The Gift of Participation” by Ken Getz, Founder and Board Chair, CISCRP.

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