Clinical Research Participation Roadmap

How do you get started on the road to clinical research participation? Our fun and informative interactive infographic paves the way with a Clinical Research Participation Basics Roadmap.

Download it here.

Medical Hero Spotlight: Jillian McNulty, Cystic Fibrosis Advocate

Born with cystic fibrosis, Jillian McNulty has spent her entire life fighting to stay healthy.

It was only during a clinical trial, when she tried a new medicine called Orkambi, that she met with success. Since then, she’s been fighting for other cystic fibrosis (CF) patients to have access to the drug too.

One of four children, McNulty’s oldest brother had cystic fibrosis and died when he was five-and-a-half. Her prognosis wasn’t good either. When she was born, doctors told her parents she wouldn’t live past her fifth birthday. She’s now 43 and jokes that she has geriatric CF, and is grateful to be alive.

Last hope
Over the years, McNulty has suffered from recurring pneumonia, and sometimes spent 8-9 months out of the year in the hospital.

“I didn’t have a great quality of life,” she recalls, noting her condition was at its worst in 2012 after her other brother, who had special needs, died. She was able to run a marathon before her lung function dropped from the high 50s (percent) to the 30s. She became dependent on IVs and antibiotics.

Fortunately, McNulty qualified for the Orkambi clinical trial, which required her to have lung functioning in the 40s and to not be hospitalized for four or more weeks.

She got emotional when she got the news that she qualified. “I can remember I cried my eyes out because to me this was my last chance, my last hope. Things started to turn after that.”

Though she struggled for the first four months of the trial, at six months her hospitalizations started to decrease. But things took a turn in 2016, when she contracted swine flu and influenza A at the same time. Her lung function was down to 11 percent. Things were grim, but McNulty pushed on.

Changing lives
“Orkambi brought me back from the brink,” McNulty says, explaining it took three months to recover.

She says the drug, which is manufactured by Vertex, works on the underlying cause of CF, a life-threatening disease that affects approximately 75,000 people in North America, Europe, and Australia.

“It’s not a cure but it tweaks the channels so our bodies respond better,” says McNulty, whose lung function is now at 42 percent.

These days, she spends only six weeks a year hospitalized. But now she’s struggling with end-stage kidney disease, another chronic condition she’s had for years, and needs a kidney transplant. But before that, she needs a lung transplant.

Still she’s optimistic about her future and the future of other CF patients.

“It’s all changing. People with CF are going to live so much longer,” says McNulty. “That’s incredible.”

The CF advocate
For the past 11 years, McNulty has campaigned for CF patients in her native Ireland, including lobbying the Irish government to make sure Orkambi and other medications were made available for CF patients. Her campaign was successful and she obtained “pipeline” approval for 10 years of promised accessibility to the drug.

“My friends were dying and I couldn’t stand by and say nothing,” says McNulty, who’s won three awards for her advocacy. “I needed people to see what Orkambi had done for me.”

She’s also been instrumental in campaigns related to the hospitalization of CF patients, helping ensure they get single-unit hospital rooms to prevent them from being exposed to other sick patients while their immune systems were so compromised.

Her advocacy continues on, and she urges patients with CF and other conditions to participate in clinical trials: “It’s worth the chance, it’s worth the risk. It has the potential to transform your life in ways you can’t imagine.” 

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: Shauna Whisenton

Shauna Whisenton was once an individual living with sickle cell disease (SCD). Now she’s an advocate for better therapies, a cure, and better under-standing of SCD.

Whisenton, now 41, was born with SCD, a painful, inherited disorder where red blood cells are misshaped, restricting blood flow and oxygen to parts of the body.

“It was all going pretty well until I had my third son,” she says. “Then my health started to take a turn for the worse.”

While nursing, she was admitted to the hospital every few weeks and, despite best efforts, was not replenishing enough fluids for her body to function properly and had major organ complications.

Her doctor asked her to consider a bone marrow transplant clinical trial to cure SCD.

Whisenton didn’t believe she could be cured and some members of her family were unsure if she should undergo the treatment. For many in the minority com-munity, there is a fear that medical testing may exploit patients instead of helping them. However, clinical trial oversights ensure safety during participation.

After consulting an SCD patient advocate, she realized, “Although a cure is not guaran-teed, this could be an amazing opportunity. If that is not possible for me, researchers could learn something from my participation to save others.”

Finding a donor

The best chance for a donor match would be a family member. Whisenton lost her parents when she was a child and her sister wasn’t a match; but her 9-year-old son, Dorian, was a 50-percent match.

A successful transplant meant a better life for Whisenton and her family.

“I felt like my children had suffered enough watching my pain,” she says.

Whisenton’s son had marrow extracted from his pelvis bone. It was a one-day procedure for him but the start of a two-year ordeal for his mother.

 
Journey

Whisenton’s journey was tough. She was hospitalized, received anti-rejection medications, and had to undergo was an important part of procedure preparation and recovery. This included coordinated care to provide relief from the symptoms of her disease and the transplant, including pain and detoxing from opiates, but also the physical and mental stress from the procedure.

“It’s important to equip someone who’s received a curative therapy with tools to rebuild their lives during and after recovery,” she says.

Within nine months of receiving the bone marrow transplant, Whisenton was SCD-free and now only carries the trait.

Whisenton calls the date of her transplant her birthday.

 
Patient advocate
 

Whisenton has made it her life’s work to help those living with SCD. She’s the manager of sickle cell disease community engagement for the ASH Research Collaborative (ASH RC) Sickle Cell Disease Clinical Trials Net-work (CTN), established by the American Society of Hematology, the world’s largest professional society concerned with the causes and treatments of blood disorders.

Whisenton is carrying out the mission of the ASH RC CTN to improve the lives of individuals with SCD by expediting the development of new therapies through innovative clinical trial research. Whisenton ensures that the voice of the patient is heard at all stages of these clinical trials.

“SCD warriors, don’t lose hope. There are many treatments in the pipeline to help those living with this disease have a better quality of life. Our hope is that advances in research will bring more effective treatments to individuals living with SCD.” 

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.

Democratizing Clinical Research

Scaling access and inclusion to clinical research is key to finding medications, therapies & treatments that work for all. Industry professionals discuss barriers to clinical trial participation and ways to address them.

Access webinar here.
PRA_Scott Schliebner For Web

Moderator
Scott Schliebner,
SVP Scientific Affairs,
PRA Health Sciences

Headshot of Dr. Teneasha Washington, PhD, MPH (Assistant Professor, Health Behavior), 2020.

Panelist
Teneasha Washington,
PhD, MPH
Assistant Professor,
University of Alabama at Birmingham
School of Public Health
Department of Public Health

Veer Mehta

Panelist
Veer Mehta,
Founder & CEO,
Halo Health Systems

Jennifer Fields

Panelist
Jennifer Fields, MPH
President,
The Hills Tandem

A New Form of Health Communication: Plain Language Summaries of Publications

Written by Kim Edwards | kedwards@ciscrp.org

New to CISCRP’s service offerings is the development of Plain Language Summaries of Publicationsalso called PLSPs. Using the same best practices that we apply to trial results summaries, we translate an original scientific article into easy-to-understand language and graphics. Together with Oxford PharmaGenesisa global provider ofmedical,regulatory,andscientific writing, we are excited to be involved in the creation of several PLSPs. These PLSPs may be a resource for patients and the public, patient advocacy groups, and non-specialist clinicians with little time. 

Each PLSP that CISCRP creates is reviewed by an editorial panel made up of patients, professionals, patient advocates, and members of the public. These volunteers provide valuable feedback to help us make sure that the PLSP is educational, clear, and complete. 

PLSPs can be published as standalone articles or alongside the original scientific article. They can be provided through a sponsor’s website, patient advocacy websites, direct mail campaigns, and webinars. While PLSPs are a new and developing form of health communication, CISCRP’s established skillset allows us to meet the increasing demand for PLSPs. Amedia and public attention around medical research and clinical trials continues to growthe value of PLSPs is clearNow more than ever, it is important that everyone has access to easy-to-understand scientific and medical information. 

We invite you to read this PLSP we createdIt was recently published in Future Oncology and translates results of the ARAMIS trial originally published in the New England Journal of Medicine. 

 

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4 Ways AWARE for All Has Adapted in 2021

Written by Ellyn Getz and Phyllis Kaplan
egetz@ciscrp.org
pkaplan@ciscrp.org

In 2020, the AWARE for All program experienced an abrupt and drastic transfer from a live-educational event model to a completely virtual engagement program. The CISCRP team shifted quickly to create accessible and meaningful virtual programs to educate the public about clinical research participation and address concerns about the COVID-19 vaccine. 

AWARE for All gathered great visibility as a fully virtual engagement program. Over 60% of our health fair visitors and webinar attendees represented public and patient communities. Walso hosted over 30 exhibitors per virtual health fair. In addition, each of the five campaigns that participated shared educational content with over 700,000 people through creative marketing and communication strategies. 

CISCRP was proud to work with the AWARE Industry Consortium, a team of ten leading pharmaceutical companies and clinical research service providers. The team also includes local advocacy and research groups to assist in leading this national outreach campaign. We are so excited to build on this momentum in 2021. 

Year 2 of the AWARE Industry Consortium will continue to focus energy and resources on community-based education. Our main focus will be to increase clinical research literacy and engage with diverse communities around the world. Consortium members include Biogen, CSL Behring, EMD Serono, Genentech, IQVIA, Janssen, Novartis, Otsuka, Pfizer, and WCG. And this year, we plan to finetune our approach to expand our reach and leverage the benefits of virtual education. 

Here are the most notable adaptions in 2021 with hopes to host in-person programs again in 2022: 

  1. Information exhibit center…in virtual reality. The team partnered with Illumina Interactive to build a virtual health fair, mimicking as close as possible the experience of an in-person exhibit hall. This virtual experience was recognized by Platinum eHealthcare Leadership award and the OMNI Awards in the Health and Fitness and Non-Profit categories. Our plan is to include one national health fair with add-on regions, share participant stories, and have health and wellness pavilion. 
  2. city-specific approach to a regional focusTaking advantage of the virtual environment, the events will be spread out over five regions across the United States, something we have never done beforeThis expanded focus should reach over 10 million people! 
  3. 2 to 3 therapeutic areas will be featured at each event. We will feature 2 to 3 therapeutic areas or medical conditions per event This will help increase engagement with those who have a special interest in these areas. 
  4. Our 2-hour webinar will be shortened to 90 minutesVirtual fatigue is something that has to now be considered, and it is no joke! We have decided to shorten the event to 90 minutes to avoid this. 

We invite you to join us as we take AWARE for All virtually on the road to these regions: 

  • AWARE  Northeast: April 15th 
  • AWARE  Northwest May 20th 
  • AWARE  Midwest July 22nd 
  • AWARE  Southwest: October 21st
  • AWARE  Southeast November 18th  

Registration details are posted on the CISCRP events website. 

If you are interested in participating as a speaker, virtual exhibitor, or outreach supporter, please email Phyllis Kaplan at pkaplan@ciscrp.org. 

 

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Doing Our Part: Improving Diversity in Clinical Research Participation

Written by Behtash Bahador | bbahador@ciscrp.org

You may have heard that the people who take part in clinical trials are not as diverse as the people who might use the treatments or vaccines being studied in trialsWe see a lack of diversity in age, sex, gender, race, and ethnicity when it comes to clinical trials. When certain groups are not well-represented in trials, it could mean researchers cannot learn enough about how well treatments or vaccines will work for them. 

Among the groups who have not been well-represented in clinical trials for many years are African Americans and Black people, Hispanic Latinos and Spanish people, and other people of color. The events of 2020 have raised the public’s awareness of social inequality and health gaps among these populations. There is also increased interest among the public about the role of clinical research in developing treatments or vaccines. 

At CISCRP, our mission has always included giving all patients and members of the public access to clear and unbiased educational information about clinical research and the results of trials. We also help researchers ensure there are fair opportunities to participate in clinical trials. As the clinical research community increases their efforts to remove some of these barriers that prevent equal representation in clinical trials, our staff continues to respond with a deep sense of urgency and commitment to do our part. 

 

“Nothing about uwithout us”the role of community engagement and education 

Like most public health challenges, making sure there is equal representation in trials requires changing several parts of a complex systemCISCRP supports making this change in 2 important ways:  

1) Engaging and working together with the communities who are not well-represented to understand the barriers they face, and 

2) Applying what we learn to help remove those barriersincluding developing educational materials with the input of those communities to make sure we are effectively connecting with them and empowering them. 

Some work has already been done to identify the barriers that prevent these communities from participating in clinical trials. The graphic below shows some these barriers. It was created based on what CISCRP has learned through working directly with members of the communities who are not well-represented in trials. 

But, the barriers each community faces are not the same. While some of these barriers can be removed with broad brush strokes that help everyone, there is no one-size-fits-all solution. This is why it is important to work closely with each community and make sure their perspectives and feedback are applied when creating and completing projects or programs aimed at removing these barriers.   

What CISCRP is doing 

To carry out our mission, CISCRP is continuing to take on projects that support improving diversity and inclusivity in clinical research. 

Our Health Communication Services team is focusing on developing educational materials that engage and inform the communities that have not been well represented in clinical trials. By seeking feedback from the community while we create these materials, we strive to make sure everything we develop is easy-to-understand, unbiased, and culturally appropriate.   

Our Research Services team continues their work to make sure we gain perspectives and insights from underserved communities through focus-groups, interviews, surveys, and user-testingOur projects center on working directly with individuals who represent the diversity that we hope to achieve in clinical trials. This includes different age groups, different sexes and genders, and diverse races and ethnicities. 

Finally, our Community Engagement and Media Awareness teams have the important role of reaching the communities who have not been well represented in clinical trials and connecting them to educational resources. We also connect them to researchers and patients who have taken part in clinical trials beforeThrough our WebinarsMedia Campaigns, and exciting Events, we are making sure the right people are having conversationabout the lack of diversity in clinical research.  

 

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2021 Perceptions and Insights Study to Focus on Diversity, Inclusion, and the Impact of the COVID-19 Pandemic

Written by Shalome Sine | ssine@ciscrp.org

Planning for the 2021 Perceptions and Insights Study is underway! 

It is more important than ever to better understand the public’s views of and experiences with clinical trials. The COVID-19 pandemic and vaccine development have taken over headlines globallyturning the public’s attention to the topic of clinical research and the pharmaceutical industryThis past year also saw the United States address racial inequities that have been built into our systems. The public’s focus on clinical trials alongside diversity and inclusion issues is unique. 

So, how have these events affected the ways that patients and the public feel about the importance of diversity and inclusion, specifically in terms of clinical trial participation? 

These are some of the biggest questions facing the industry, and CISCRP’s Perceptions and Insights Study can help to answer them. The Perceptions and Insights Study is a global survey of thousands of respondents that has taken place every 2 years since 2013. The study assesses current attitudes toward clinical research and experiences participating in clinical trialsAs we prepare and plan for this year’s survey, here are 3 ways the 2021 findings can help inform your patient engagement strategy: 

  1. Trends: We’ll carry questions from previous years so that we can continue to track trends over time. This will allow you to see how the events of 2020 have impacted perceptions and experiences of clinical research compared to previous years.

  2. COVID and the rise of remote clinical trial models: We’ll ask those who participated in clinical trials whether they used technologies or alternative clinical trial models (like virtual or home nurse visits), as these were often used in 2020 to limit in-person contact and reduce the spread of COVID-19We’ll also ask how these new technologies impacted their experiences and satisfaction as a clinical trial participant.
  3. Diversity and inclusion in clinical trials: The 2021 survey will also include new questions on diversity and inclusion in clinical trials, offering valuable insights into the views of patients and the public on the importance of including a diverse group of participants in the clinical research process. We will also look at the motivations and experiences of underrepresented communities to identify ways to improve engagement among these groups. 

The survey will launch later this spring, with results available in September 2021. Keep an eye on the CISCRP website to be notified as soon as results are available! 

Click here to review the results of the 2019 Perceptions and Insights study and see general trends found over time so far. 

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CISCRP Supports Operation Warp Speed Vaccine Sponsors with Plain Language Communication

Written by Jill McNair | jmcnair@ciscrp.org

In December 2020, CISCRP announced that it is providing plain language communication consulting and services to companies involved in Operation Warp Speed.” As readers may know, Operation Warp Speed is a public-private partnership started by the US government to help in the development, manufacturing, and distribution of COVID-19 vaccinesCISCRP has pledged to volunteer our knowledge and resources to assist Operation Warp Speed sponsors. We are pleased to be providing our services to AstraZeneca, Janssen Pharmaceuticals, Moderna, and Pfizer. 

For more than 10 years, CISCRP has been translating scientific clinical trial results information into plain language for patients and the public around the world. To deliver on our pledge, CISCRP is continuing to do this by assisting Operation Warp Speed vaccine sponsors in a variety of ways. This includes: 

  • developing, producing, and distributing plain language trial results summaries 
  • translating scientific medical journal articles into plain language 
  • preparing plain language content to be communicated in print and digital formats  

Oxford PharmaGenesis, a global provider of medical, regulatory, and scientific writing, will also be volunteering its services together with CISCRP to support Operation Warp Speed sponsors. 

The demand from the public, patients, and the healthcare community for plain language information about the results of COVID-19 vaccine trials is high. Health officials and Operation Warp Speed sponsors also believe that providing clear information and results is necessary to gaining public trust and support for other vaccination programs in the future. 

Said Ken Getz, CISCRP’s founder and board chair“Given the incredible time and resource pressures that Operation Warp Speed vaccine sponsors are facing, CISCRP decided to donate staff time and expertise, its editorial panel of patients, and print production and distribution costs. We’re very pleased to be collaborating with so many COVID-19 vaccine sponsors. And in the process, CISCRP can ensure consistenthigh quality, and compliant practices across sponsor companies. 

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