Improving Access to & Experiences of Transgender & Non-Binary Patients in Clinical Research

Rosamund Round, Vice President, Patient Innovation Center & Decentralized Trials, Parexel International, Liam Paschall, Global Training Business Partner, Parexel International and Dr. Sebastian Barr, PhD, Licensed Psychologist & Consultant, discuss the barriers that transgender and non-binary individuals face to medical care and ways to scale access to clinical research participation.

Related Articles:
Working Towards A More Inclusive Environment: Transgender & Non-Binary Participants in Clinical Research
Improving Access to & Experiences of Transgender & Non-Binary Patients in Clinical Research

About the Panelists

Rosamund Round, Vice President, Patient Innovation Center & Decentralized Trials, Parexel International

Click Photo to Read Bio

Liam Paschall, Global Training Business Partner, Parexel International

Click Photo to Read Bio

Dr. Sebastian Barr, PhD, Licensed Psychologist & Consultant

Click Photo to Read Bio

Understanding DCTs: Decentralized Clinical Trials

Authored by: Melissa E. Daley, Communications & Marketing Manager, CISCRP

The advent of the COVID-19 pandemic has scaled public interest in clinical research, and has increased the implementation of DCTs, decentralized clinical trials. SMEs from Curebase, a software and services provider specializing in DCTs, shared what DCTs are, how they work and differ from the traditional model of clinical conduct, and the importance of diverse participation in a 15-minute Flash Webinar. Arsheen Ali, Clinical Project Manager, began by outlining the conventional approach to clinical trials.

“Traditionally, clinical research activity occurs in person, at a designated physical location, which is generally referred to as a research site,” explains Arsheen. “A doctor, called a PI or Physician Investigator, along with other clinical research staff including nurses and clinical research coordinators, facilitate participant care and the collection of data around the clinical study so that the data can be analyzed.” Participating in a clinical study introduces many moving parts for patients and caregivers, including issues around travel to and from the study center, taking time off from work, coordinating childcare and other personal impacts.

To gain better understanding of how DCTs provide an added level of convenience for participants, Myra Lane, Lead Virtual Research Coordinator shared that 

“Decentralized clinical trials help promote a more patient-centric approach, addressing participants needs that go unmet in traditional clinical trial models. DCTs typically incorporate the use of technology and digital tools that give the participant convenient options to provide information that’s needed for the trial, to interact with research staff, and to complete study activities.” The use of technology allows participants to complete part of, or in some cases, all the study activities remotely.

If there are parts of the study that cannot be completed remotely, an alternative location can be selected. This may include the participant’s home, workplace or their own doctor’s office. One example is when a mobile phlebotomist is sent to where a patient lives to conduct a blood draw.

“A decentralized clinical trial does not necessarily mean that a participant will never interact in person with a member of the research staff,” adds Adam Samson, Senior Director of Clinical Operations and Customer Success. Decentralized clinical trials can use a combination of approaches to coordinate patient care and study conduct. As in telemedicine, different communication forms are employed including phone calls, video calls and text messaging.

DCTs greatly scale the convenience factor for participants and caregivers. Traditional clinical trials often required long distance travel to the closest research site, hotel stays and time off from work. Removing geographic barriers and eliminating time constraints means that a greater diversity of patients are able to participate. For study data to represent a universal population, diverse participation is essential.  DCTs are paving the way to opening clinical trials to populations that historically faced barriers to participation, including minorities and residents of rural communities.

“The term decentralized clinical trials does not refer to just one thing. It might be that everything is done from the participant’s home, or it could be that the participant chooses to go in for certain things. When it comes to the use of technology, it’s important for participants to understand what the details are around the devices and technology, in order to decide whether it’s something they’d be comfortable with,” says Adam.

Patients’ bodies react differently to medications based on characteristics including age, gender, race and ethnicity. By reducing burdens to participating in a clinical trial, DCTs increase access to clinical research to a diverse pool of participants. In turn, the length of time it takes to develop new treatments and therapies can be decreased.

“Participating remotely is just as important as participating in person,” says Arsheen. “Your participation makes a really big difference in moving science forward.”

Learn more about DCTs by accessing the webinar recording here. View CISCRP’s library of webinars and podcasts 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.

Spring 2021

Spring 2021 Campaign

Visit our Library
of Clinical Research Educational Resources.

FAQ About Clinical Research

View Educational Videos

Expanded versions below.

View & Download Our Latest Campaign here.

Spanish Version: View & Download here.

View Content by Clicking on each Newspaper Title

A Very Special 'Thank You' to the Supporting Organizations

Merck

BMS

Lilly

AstraZeneca

Oxford PharmaGenesis

Biogen

Pfizer

SubjectWell

Allergy & Asthma Network

Amicus Therapeutics

Praxis

Thank You to Praxis

CISCRP would like to recognize and extend a ‘Thank You’ to Praxis for donating their pro-bono graphic design services to create the full page advertisement. View the advertisement here by clicking on the star.

 

To participate in this or another upcoming media campaign to continue to build education and awareness about clinical research, please contact Matt Steele at msteele@ciscrp.org.

 

Key Insights Into Clinical Research Perceptions Among Parents and Children

Written by: Shalome Sine
Project Manager
CISCRP Research Services

The findings of a recent pediatric survey illustrate perceptions and insights on what matters most to patients and their parents. It also offers ways to best support and inform prospective pediatric volunteers and their guardians before, during, and after the clinical research process.

During the month of April 2020, the Center for Information and Study on Clinical Research Participation (CISCRP) conducted an online United States-based survey among 500 parents and their children. The goal of this survey was to gain insight into general perceptions of pediatric trials, preferred channels of communication, key information parents and their children would want about pediatric clinical trials, as well as past or current experiences participating in pediatric clinical trials.

Awareness & Understanding
Parents generally self-report high levels of understanding about clinical research, and generally high willingness to have their child participate in a clinical research study. Awareness, understanding, and willingness to have their child participate was greatest among parents whose children have previously participated in clinical research.

Among children, levels of awareness of clinical research vary by a child’s age, as older children were more likely to have heard of clinical research compared to younger children. Overall, few reported that they understood clinical research “very well.” Though many were not sure whether they would want to participate, 50 percent reported that they would be willing. The top motivation to participate was altruistic, as children wanted to advance science through their participation.

Participation Experiences
During participation, parents reported highly burdensome experiences and high levels of disruption to their daily routine. Top burdens included traveling to the study clinic and having their child complete lab work like blood draws and urine tests. However, the majority of parents said that they received updates or study results once their child finished participation.

Results also indicate that children generally received adequate information about their participation. Ninety-two percent remembered getting information about the clinical trial before they joined, and 85 percent found this information “kind of” or “very easy” to understand. Despite these expectation-set-ting measures, children reported some study requirements as difficult to complete, most notably taking the study medication and undergoing blood draws. However, though children report burdensome study experiences, most indicate that the study exceeded their expectations, and that they would be willing to participate again.
Doctors are Key

A consistent theme throughout the survey findings was the critically important role that healthcare professionals play along the journey toward participation. For example, parents discuss clinical research with their child’s doctors often and cite their child’s doctors as the top way they learn about participation opportunities. Children would also most prefer to learn about clinical research through their doctor. Doctor recommendations were ultimately the top reason that parents decided to have their child participate. 

Article from 2020 Clinical Trials Supplement, USA Today. View Supplement Here >

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

Written by Melissa E. Daley, Communications & Marketing Manager| mdaley@ciscrp.org

“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 Pittsburgh with 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.

Letter From the Editor

Written by: Scott Finger | sfinger@ciscrp.org

Dear readers,

If you have been following CISCRP and our newsletter, you know about some of the exciting and innovative changes we have made over the last year and a half. While we understand it can be tiring to hear so much about the pandemic and the “new normal,” we can’t overstate how important it is to continually address disparities in health care and clinical research. In this issue, we cover some of the changes we have been making and what you can expect from us in the coming months.

One of CISCRP’s biggest initiatives has been to address the inequity of participation in clinical trials. In other words, we want to turn underrepresented communities into represented communities. Our Health Literacy team is collaborating with members of these communities to learn how we and clinical trial professionals can bridge the gap. We will add this knowledge to our library of educational brochures, so stay tuned for the finalized publications. Also in this issue, we discuss how our AWARE for All live educational series focuses on diversity and inclusion. Our next event is happening October 21, and our final AWARE event of the year will be held on November 18.

Our efforts would not be possible without our Research Services team having important conversations with the community. The results of our Perceptions & Insights Study, conducted every two years, will be available this fall! Read here for a sneak peek of some of the key findings, including responses from members of ethnically and racially underrepresented communities.

In our Supporter Spotlight article, Luther T. Clark, MD, Deputy Chief Patient Officer of Merck, explains some of the other issues surrounding healthcare disparity. These issues include the pandemic, social and economic factors, and certain groups’ lack of access to technology (known as the “digital divide”). With in-person interactions becoming rarer, it is important now more than ever to help communities without the proper resources.

CISCRP is also taking steps to make research results more accessible. The results of clinical trials and other scientific studies are incredibly complex, and there is a large demand for plain language information. In response, we have partnered with sponsors and other experts to create “plain language summaries of publications” (PLSPs), which turn hard-to-understand articles into easy-to-understand summaries. This new offering expands our plain language portfolio to include not only trial results summaries, but all types of scientific and medical articles.

It takes a community to make change, and that is absolutely true when it comes to clinical research. In this issue, we highlight the efforts and the experience of CISCRP’s own Phyllis Kaplan in our ongoing Medical Hero Spotlight series. Read here to learn more about Phyllis’ journey from patient and advocate to clinical research participant to Senior Manager of Events & Community Engagement at CISCRP.

While the clinical research community has become more aware of the disparity in representation, clinical trials are still not as diverse as they should be. We still have much work to do to address the knowledge gaps that exist within the general public. Whether you are a health professional or member of the community trying to do your part, we encourage you to learn as much as you can about clinical trials and the important issues we need to address. As a team, we can make a difference to ensure that all voices are heard, and that research accounts for people of all backgrounds.

Take care, and stay safe,
Scott Finger
Editor, Health Literacy

 

Go Back to the Newsletter >

Medical Hero Spotlight: Phyllis Kaplan & Type 1 Diabetes

Written by: Melissa E. Daley, Communications & Marketing Manager, CISCRP

Phyllis has a vague recollection of waking up in a hospital with tubes attached to her body, and a distinct memory of saying, “Take the tubes out!” At the age of two, she was diagnosed with type 1 diabetes, an autoimmune disease, typically diagnosed in childhood, but can manifest at any age. Diabetes has led Phyllis on a path from patient to advocate to clinical research participant.

“I have been an advocate since I was 12 years old. It started in junior high school, in a gym class when the teacher made me take off my medical alert bracelet, due to a ‘no jewelry in gym class’ rule,” says Phyllis. When she went to retrieve the medical bracelet from the gym locker after class, she discovered it had been stolen. This incident spurred Phyllis to write a letter to the town superintendent of schools, demanding its replacement and a change in the rule to allow medical-related items to be worn. By the time the letter had been delivered, the bracelet had been anonymously returned to the school’s lost & found box. Phyllis was allowed to wear the bracelet moving forward.

The most important thing to understand about type 1 diabetes, says Phyllis, is, “The patient or caregiver has to make so many decisions about the disease, every day with no break. With diabetes, every day is different.”

Type 1 diabetes develops quickly. The body’s immune system attacks and destroys beta cells in the pancreas that create insulin. The body cannot produce insulin without these beta cells. Insulin is a peptide hormone that helps your body metabolize fats, proteins and carbohydrates through glucose (a type of sugar) that is released into the bloodstream when you eat food. The glucose is then absorbed from the blood in the liver, fat and skeletal muscle cells. Type 2 diabetes develops more slowly, over time. The body produces insulin, but cannot use it effectively.

Decisions about how much medication to take are based on many variables including food, exercise, change in weather, change in personal schedule, and stress.

“That’s why education is so important,” says Phyllis. “If I am going to exercise, I have to plan ahead, at least a couple of hours before, as exercise impacts blood sugar. There are so many hidden things to know about diabetes that impact your decisions.”

 

Phyllis has participated in four clinical trials: two for rescue medications for severe hypoglycemia and one for a medical device.

 

“As a longtime advocate, I felt that participating in a clinical trial was the ultimate form of advocacy,” Phyllis explains.

“The trials were very different from each other,” says Phyllis. “Two of the three were very easy. One involved two full days in clinic, and that was really hard, with nine hours of ongoing blood tests. Those were physically difficult days, but worth it. The other two clinical trials were less invasive.”

When considering the two-day, in-clinic trial, Phyllis and her husband reviewed the protocol together. “I wouldn’t participate without consulting him,” says Phyllis. He accompanied her to the two in-clinic days, to be with her during the nine hours of ongoing tests and to lend additional support.

When asked if she faced any concerns from family or friends about her clinical research participation, Phyllis says, “No, quite the opposite. People were really interested in the ‘why’ of what I was doing and what the outcomes were.” Phyllis didn’t seek any advice from patient advocacy organizations, because of her own experience as an advocate. She is a brand ambassador with Medtronic Diabetes to share her experience with their medical device, and also volunteers with JDRF (Juvenile Diabetes Research Foundation) and ADA (American Diabetes Association).

 

Phyllis advises individuals considering clinical research participation to “Ask all the questions you have when meeting with the nurse/study lead. No question is too silly.

Read the protocol and informed consent, which can be confusing. Use a highlighter to mark items in the protocol or use Post-its to make notes. Keep asking questions throughout the course of the study. At times the research staff may not always be patient-centric, and if you’re not getting the answers to your questions, ask to speak with someone else on the study team. Be your own best advocate and keep pushing. Researchers are not always prepared to answer patients’ questions. If something doesn’t sit well with you, voice it.”

Her experience as a clinical trial participant has strengthened Phyllis’ commitment in sharing information about the importance of clinical trials to everyone. Phyllis is adamant and passionate about participating in clinical research again if the opportunity presents itself, reiterating,

 

“Absolutely. Without clinical trials, new treatments can’t happen, and without clinical trial participants, clinical trials can’t happen.”

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.

 

Go Back to the Newsletter >

Why Clinical Trial Diversity Is Key To Increasing Access To Routine Care And Innovative Treatment Options

By: Luther T. Clark, MD, Deputy Chief Patient Officer, Merck

The COVID-19 pandemic has shone a light on longstanding health care disparities and amplified the importance of clinical trial diversity, especially participation of those patients and communities disproportionately impacted by the disease being studied. Since clinical trials function as the gatekeeper to bringing new medicines safely to patients and communities, it has become increasingly important that diverse communities be represented in our research efforts.

Clinical trial participation provides access to possible new and innovative treatment options for patients, an especially important benefit for those who have conditions with limited treatment options – such as some forms of advanced cancer.  It is important to note that, while not all clinical trial participants will receive the investigational treatment being evaluated in the clinical trial, all patients receive high quality standard-of-care, which is the standard treatment that is used for the health condition.

During the COVID-19 pandemic many patients have delayed or avoided routine medical care for underlying conditions – a hidden harm that has further amplified its already enormous health toll. While pandemic associated medical care delays and avoidance may be understandable, safely returning to essential care is imperative for improving patient outcomes and reducing disparities as well as increasing patient access and ability to participate in clinical research. 

Pandemic Associated Medical Care Delays and Avoidance
During the COVID-19 pandemic, delays and/or avoidance of medical care for both routine and serious conditions have been widely reported. According to one recent analysis (1) an estimated 41% of adults in the U.S. delayed or avoided medical care because of concerns about COVID-19 – including both routine care (31.5%) and urgent or emergency care (12.0%).  Avoidance of urgent or emergency care was more prevalent among individuals with underlying medical conditions, Black adults, Hispanic adults, young adults, persons with disabilities and unpaid adult caregivers. When patients delay or avoid medical care, they increase both their morbidity and mortality risks. For example, 

  • Vaccines play an important role in helping to protect people from preventable diseases, but data show concerning decreases in vaccination rates since the onset of the COVID-19 pandemic. A recent international poll revealed that 73% experienced disruptions in vaccine demand.
  • Similarly, while routine cancer screenings have contributed to important cancer survival gains, screening rates have dropped during the pandemic. In the U.S. alone, approximately 285,000 breast cancer screenings, 95,000 colon cancer screenings and 40,000 cervical exams were missed between March 15 and June 16, 2020.

Cancer is a particularly powerful example of how longstanding inequities in care coupled with the pandemic’s impact on reduced access/utilization of routine health care can converge and create an even more devastating impact on patients, families and communities. Cancer incidence is known to be disproportionately higher in under-represented minorities compared to other groups, and access — to timely diagnosis, quality care and to clinical trials of promising therapies — is suboptimal among people of color. Furthermore, cancer and its treatment predispose to many other health outcome disparities, as demonstrated by the disproportionate impact of COVID-19 on morbidity and mortality rates among people with cancer.   

Social Determinants of Health (SDOH)
Social and economic factors, referred to as social determinants of health (i.e., education, economic stability, neighborhood, health and health care access, social and community context) not only contribute to healthcare disparities but may also negatively impact the decision and the ability of patients to participate in clinical research (2-4).  By recognizing and understanding the SDOH, we can help accelerate return to medical care, overcome barriers to minority participation in research, and ultimately improve patient outcomes. Effective and meaningful community engagement, collaborations, and partnerships are critically important for addressing all of the SDOH, and especially helpful for increasing awareness, education and building trust.

Bridging the Digital Divide
Digital technologies have many potential benefits for improving healthcare, including the potential to improve healthcare quality, patient safety and reduce disparities (5).  However, inequities in access to virtual technologies do exist and may lead to or exacerbate disparities. Often referred to as the “digital divide”, there is a considerable difference between those patients/communities that have access to digital technologies and the ability to understand and use them effectively (digital literacy) and those who do not.  For example, access and utilization of digital health care technologies are known to be significantly lower among older Black and Hispanic patients than their white or Asian counterparts.  In addition to differences in access and digital literacy, structural inequities (i.e., lack of broadband internet availability) impact disproportionately some groups and communities – racial and ethnic minorities, rural communities and individuals of lower socioeconomic status (6). Without recognition and action, the digital divide will only widen.

Summary and Conclusions
It is important for the medical and public health community, policymakers, employers and health advocates around the world to come together to encourage people within our communities to get the care they need.

  • As we join the multi-sector effort to combat COVID-19, we must also focus on helping people in our communities get the routine care they need to protect their long-term health.
  • It’s vital to support individuals and patients in returning to care because delays or cancellations are associated with significant health risks.
  • While the COVID-19 pandemic has caused unprecedented disruption to the healthcare system, it has also led us to identify opportunities to strengthen it for the future. We are committed to working with stakeholders to enact solutions that will improve patient care and help protect public health over the long term.

 

This article was also featured in our Patient Diversity Campaign. See Campaign Here.

Go Back to the Newsletter >

References:

  1. Czeisler MÉ, Marynak K, Clarke KE, et al. Delay or Avoidance of Medical Care Because of COVID-19–Related Concerns — United States, June 2020. MMWR Morb Mortal Wkly Rep 2020;69:1250–1257. DOI: http://dx. doi.org/10.15585/mmwr.mm6936a4
  2. Clark LT, Watkins L, Pina IL, Elmer M, Akinboboye O, Gorham M, Jamerson B, McCullough C, Pierre C, Polis AB, Puckrein G, Regnante JM. Increasing Diversity in Clinical Trials: Overcoming Critical Barriers. Curr Probl Cardiol 2019; 44:148-172
  3. Asare M, Flannery M, Kamen C. Social Determinants of Health: A Framework for Studying Cancer Health Disparities and Minority Participation in Research. Oncol Nurs Forum. 2017 January 02; 44(1): 20–23.  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5583708/pdf/nihms893015.pdf
  4. Weinstein JN, Geller A, Negussie Y, Baciu A. Communities in Action: Pathways to Health Equity. Report of the National Academies of Sciences Engineering Medicine (2017). https://www.ncbi.nlm.nih.gov/books/NBK425848/pdf/Book-shelf_NBK425848.pdf
  5. Lopez L, Green AR, Tan-McGrory A, King R, Betancourt JR. Bridging the digital divide in health care: the role of health information technology in addressing racial and ethnic disparities. Jt Comm J Qual Patient Saf 2011 Oct;37(10):437-45. doi: 10.1016/s1553-7250(11)37055-9.
  6. Campos-Castillo C, Anthony D. Racial and ethnic differences in self-reported telehealth use during the COVID-19 pandemic: a secondary analysis of a US survey of internet users from late March. Journal of the American Medical Informatics Association, 28(1), 2021, 119–125. doi: 10.1093/jamia/ocaa221

Results From The 2021 CISCRP Perceptions & Insights Study Coming Soon

By: Jessica Cronin | jcronin@ciscrp.org

CISCRP is excited to announce that the full results of the 2021 global Perceptions & Insights Study will be available this fall! This latest study contains insights from nearly 12,000 individuals around the world on various aspects of clinical research — including the impact of the COVID-19 pandemic on awareness and perceptions, as well as thoughts on and experiences with clinical trials that require fewer visits (decentralized trials). These results uncover significant new findings on patient engagement preferences and ways to increase access, particularly among underrepresented communities.  

Our 2021 study captured the experiences of over 5,500 trial participants across diverse therapeutic areas, which was nearly 2,000 more participants than in previous years!  

Key findings from the 2021 Perceptions & Insights Study include:

  • Most respondents (75%) noted that the COVID-19 pandemic increased their overall awareness of clinical research, particularly among those from ethnically and racially underrepresented communities.
  • Individuals from ethnically and racially underrepresented communities were significantly more likely to cite that knowing pharmaceutical companies employed diverse staff would help to increase their trust in pharmaceutical companies.
  • While most (82%) said that they were willing to participate in clinical research, about one third of individuals (36%) cited being more willing to participate as a result of the COVID-19 pandemic.
  • Of those who participated in a clinical trial during the pandemic, top changes reported included a shift from in-person visits to virtual clinic visits (over the telephone or computer), and an increase in the use of telemedicine and home trial drug delivery. Only 20% reported that their clinical trial was temporarily stopped. Consistent with prior studies, most clinical trial participants (92%) noted that their trial met or exceeded their expectations, with a significant percentage (95%) willing to participate in another trial in the future — a strong indicator of overall satisfaction.

Since 2013, CISCRP has conducted the Perceptions & Insights Study every other year to monitor trends and identify opportunities to better inform and engage the public and patients as partners in the clinical research enterprise.

To review these findings and more from the 2021 Perceptions & Insights Study, CISCRP will be hosting a webinar in October, as well as posting reports on the CISCRP website. If you would like to register for the webinar – please go to here.

 

Go Back to the Newsletter >

PLSP: The Results Of The DESTINY-Breast Cancer01 Clinical Trial Published In Future Oncology

Written by: Joan Chambers | jchambers@ciscrp.org

CISCRP and Oxford PharmaGenesis collaborated with Daiichi Sankyo, AstraZeneca, and Dr. Shanu Modi of the Memorial Sloan Kettering Cancer Center in New York to write a plain language summary publication (PLSP) of the results of the DESTINY-Breast01 clinical trial.

The demand from the public, patient, and health care communities for plain language information on results of clinical trials is extremely high. For more than ten years, CISCRP has been translating scientific clinical trial results information into plain, easy-to-understand language for patients and the public around the world to be communicated in print and digital formats.

This PLSP provides important information about HER2-positive breast cancer to patients, their family members or caregivers, and patient advocates. In a simple format, the PLSP highlights and addresses: what HER2 positive breast cancer is, why the clinical trial was conducted, the most common adverse events, and the overall trial results.

Over 253 women aged 18 and older participated in the trial. This PLSP answers the main questions researchers had in the DESTINY-Breast01 trial:

  • Did the participants’ tumors shrink or disappear after receiving the T-DXd treatment?
  • For how long did the participants’ tumors shrink or disappear before growing again?
  • For how long did the participants live with their cancer before it got worse?
  • What were the most common adverse events during treatment with T-DXd?

The PLSP team worked to ensure the PLSP was easy to read by adding creative visuals, tables, and answers to key questions about the DESTINY-Breast01 clinical trial. The PLSP was reviewed by an editorial panel of patients, patient advocates, members of the public, and healthcare professionals to evaluate and confirm that a “patient-first” approach was taken. The panel reviewed the writing, design, and layout to help patients, family members, and caregivers understand the trial results.

Read the full published PLSP on Future Oncology here.

CISCRP collaborates with industry organizations to create documents from scientific manuscripts that are accessible for patients, patient advocacy groups, and the public. Visit Health Communication Services for more information. 

Go Back to the Newsletter >