AWARE for All Northeast

Written by Hope Ventricelli | Manager of Events and Community Engagement

For the first time, CISCRP brought its AWARE for All program to regional areas across the United States while remaining virtual. The AWARE for All program was created to raise awareness about the clinical research process and to provide education among diverse communities. The webinar for the first edition of this series, AWARE for All — Northeast, went live through the virtual platform ON24 on April 15th. For those who wish to watch on-demand or continue their learning, a recording of this webinar is available through the Informational Exhibit Center (IEC) found on the CISCRP website. The IEC features educational content from organizations across the Northeast, spanning multiple states and therapeutic areas. The IEC is designed to be easily accessible and to address the lack of knowledge about the clinical research and health resources in the audience’s “own backyard.”  

The CISCRP Events Team brought in more than 40 exhibiting organizations for the series’ opening event, from clinical research sites to community clinics and local health centers. Each shared free educational resources with the audience in the IEC. While several groups offer information about the trials they offer, most exhibitors simply aim to provide general education or medical information about specific health conditions. This helps to include those not as familiar with research and to make them feel comfortable learning more. Attendees cited their desire to learn more about research as their main reason for registering. Many also shared that they have a friend or loved one with a health problem.  

The IEC had an impressive number of viewers. More than 1,800 new and returning community members visited the virtual educational booths and the new Health and Wellness Pavilion, which features health tips and exercises.  

Through post-event surveys, audience members shared that their biggest takeaway was that they better understood the clinical research process and were grateful to have their questions answered in real time. As to their favorite part of the program, most attendees referenced the panel discussion. 

Through the panel discussion, AWARE for All — Northeast focused on key health issues such as oncology, Parkinson’s Disease, asthma, and the importance of diversity among trial participants. Outreach to minority health groups helped to bring a diverse audience from the local population to hear more from the speakers themselves. The lively discussion, which was moderated by CISCRP’s own Behtash Bahador, included several study participants as well as local researchers and industry stakeholders. These experts shared their individual experiences and answered questions the audience most wanted to know. 

Each virtual AWARE for All program aims to bring the research community, patients, and the public together to support a discussion in understanding clinical research and, most importantly, the role of study participants. 

Including the Northeast edition, CISCRP’s AWARE for All program will virtually host in 5 different regions through 2021. Future programs include Northwest on May 20th, Midwest on July 22nd, Southwest on October 21st, and Southeast on November 18th.  

To learn more about exhibiting at AWARE for All, contact hventricelli@ciscrp.org. 

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Supporter Spotlight: Patient Diversity Initiatives

CISCRP is developing a series of articles about initiatives from pharmaceutical companies to address racial inequities and health care disparities with a focus on clinical trial diversity.   

For our first Supporter Spotlight piece of the series, we feature two companies—Merck and Pfizer—our 2021 “Patient Diversity Campaign” editorial content providers.  

The COVID-19 pandemic has heightened awareness about the importance of clinical research. The pandemic has also placed a spotlight on racial inequalities within our U.S. health care system. Over this past year, we’ve seen many companies increase transparency by publishing clinical trial results summaries, hosting advisory boards, supporting mass media awareness-building campaigns, and collaborating with local communities.  

We met with colleagues from Merck and Pfizer to learn how they’re understanding critical barriers to participation and increasing health literacy among patients and the public.  

Here are three key insights from these two industry leaders that showcase their commitment to improving diversity and inclusion: 

Develop solutions that resonate among different stakeholders.  

“There are multiple barriers to diversity in clinical trials and multiple stakeholders who have the responsibility to address them,” shared Luther Clark, Deputy Chief Patient Officer at Merck. “We are strongly committed to conducting research that is safe and effective in all patients.” To demonstrate this commitment, Merck executes their clinical trials with a focus on meaningful patient and community engagement, addressing the social determinants of health, logistical and financial barriers, and minority investigator shortages.

One way Merck works to remove barriers and ensure equitable access to clinical trials is through heat map technology. This allows them to identify patients with the greatest disease disparity and need for medication. Adrelia Allen, Director of Clinical Trial Patient Diversity at Merck, shared the importance of this technology and of working closely with sites and community leaders. “[Prioritizing diversity and inclusion] is a part of the fabric of our corporate culture. It’s embedded into our clinical trial operations,” said Allen. 

At Pfizer, effective communication with community members is a priority. “Clinical trial accessibility starts with clinical trial awareness,” shared David Leventhal, Senior Director of Clinical Trial Experience at Pfizer. “There’s a difference between reading about clinical trials on the internet and really understanding a clinical trial as a care option.”  

Both Pfizer and Merck support CISCRP’s Perceptions & Insights bi-annual study to understand public and patient perceptions around trial participation and barriers. Both companies are writing full-page editorials about their commitment to achieving health equity in CISCRP’s Patient Diversity 2021 campaign.  

Learn about what matters most to patients and their families.  

Pfizer incorporates patient insights into their protocol designs and engages with patients and local advocacy groups. “We’ve learned that being a part of an alumni network is important to our participants, so we’ve expanded that around providing individual results, data return, and an opportunity to share stories,” said Leventhal. They also partner with local communities and work with advisory boards to ensure clear, consistent messaging.  

At Merck, organizing advisory panels, partnering with advocacy groups, and hosting forums helps gather direct input from patients. In addition, Merck is committed to improving health literacy around the world to advance health equity, impact population health outcomes, and drive efficiencies in health care systems. 

To develop best practices to increase diversity, Merck and Pfizer also work with major consortia, such as CISCRP’s AWARE Industry Consortium, PhRMA, the Diversity & Inclusion in Clinical Trials (DICT) Collaborative, and the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard. 

Maintain relationships with local communities.  

“With educational awareness programs, we’re showing that we’re there to support communities,” said Allen. Merck has supported external grass-roots programs, such as CISCRP’s AWARE for All events and the Lazarex Cancer Center’s equitable access initiative. 

Clark added, “The first step is recognizing and overcoming mistrust, fear, and lack of comfort with the clinical trial process. Ultimately, it’s the patient who will make the decision about participation, but they’re influenced by people close to them—their families, friends, and the greater community.” 

Pfizer supports CISCRP’s AWARE for All programs and developed an FAQ on pfizerclinicaltrials.com to increase transparency and address concerns among underserved communities. They develop their educational materials in partnership with academic centers and advocacy groups to build trust, cultivate strong collaborations, and ensure best practices in health literacy. Pfizer also partners with large health systems to avoid multiple data collection mechanisms and support interoperability.  

Taking the time to understand participation barriers and meet the needs of participants is an investment in the future. 

“It’s not a sprint; it’s a marathon,” said Allen. “We’re willing to put forth the effort and resources to improve patient outcomes and achieve health equity for all.” To learn more about Merck’s commitment to diversity in clinical trials, click here. 

Tune in to the next article of the series where we’ll be profiling other companies!  

Author: Ellyn Getz, MPH, Associate Director, Business Development 

 
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Endpoint Selection in Plain Language Summaries: Insights from CISCRP’s Third Annual User Group Meeting

Written by Kim Edwards

On February 19, 2021, CISCRP hosted our Third Annual Plain Language Summary of Trial Results Virtual User Group Meeting. This meeting provides an opportunity for sponsors to participate in facilitated discussions about evolving or challenging aspects of developing plain language trial results summaries (referred to here as “PLS”). This year, topics included adverse events/reactions reporting, translations, dissemination, posting deadlines, and endpoint selection.  

In particular, the discussion about endpoint selection was spirited.  The group addressed the ongoing debate about whether it is appropriate to include secondary endpoints in PLS, and how this decision should be guided and documented. The biggest challenge with including secondary endpoints is striking a balance between providing the reader with relevant results of interest while also avoiding “cherry-picking” that leads to perception of bias. To avoid this perception, some sponsors advocate for clear guidelines across all plain language summaries within their organization. For example, some companies have created a policy to include only the results of the primary endpoint, regardless of the nature of the trial. Other sponsors suggest that this is not necessarily a patient-focused approach, as there may be secondary endpoints that are of particular interest to the trial participants.  

To get a snapshot of the current practices among our User Group participants, CISCRP asked the following poll question: Does your organization have a documented endpoint selection process and/or policy for plain language summaries? Interestingly, the responses, presented in the graph below, were quite evenly distributed.  

These results highlight the lack of a standard approach to endpoint selection. Later this month, we expect the release of a paper from industry stakeholders that offers suggestions on endpoint selection. In the meantime, we offer these three considerations: 

  1. Audience – Do your trials include secondary endpoints that participant readers will care about and want to learn about? 
  2. Cherry-picking – Can your organization implement secondary endpoint selection criteria across all trials and/or require protocol authors to indicate participant-relevant secondary endpoints prior to data collection? 
  3. Feasibility – Will a standard approach be practical for those in your organization who must operationalize it?  

We are grateful to the participating sponsors for their insights, collaboration, and dedication to providing participants with meaningful plain language trial results.  

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CISCRP’s Third Annual Medical Heroes Appreci-a-thon

Written by Justine Holleran

Throughout the month of March, CISCRP hosted its 3rd annual Medical Heroes Appreci-a-thon to bring together a community of almost 350 “racers” to express their appreciation for all “Medical Heroes”—medical and healthcare professionals, researchers, and clinical trial participants. 

This month-long virtual fitness challenge encouraged racers to go the distance to recognize Medical Heroes by tracking any form of exercise—cycling, running, yoga, yard work, pet-walking, and more. Any physical activity was translated into “miles,” and racers and their teams could virtually track their progress through a trail of U.S. national parks. 

Racers were able to stay active, strike up friendly competitions, and participate in fun weekly challenges all while learning about clinical research and reading stories about the Medical Heroes that brought them all together for this event. 

Appreci-a-thon attracted 346 racers and 90 teams. Our athletes collectively covered 29,647 miles of the course. Racers participated from almost all 50 U.S. states, Russia, England, Japan, Belgium, Germany, and more! With the support of our sponsors and racers, we were able to exceed our fundraising goal for this program. All funds support important CISCRP initiatives such as our educational events, appreciation programs, and more.  

The Value of Patient Advisory Boards in Understanding Receptivity to New Technologies in Healthcare and Clinical Research

Written by Rebecca Nordland

The COVID-19 pandemic has forever changed nearly all aspects of the way we live and work. Healthcare, and by association, clinical research, has been among the sectors most affected by significant changes to their standard practices and procedures.  

Given the need for reduced in-person interaction between healthcare providers and patients and the resulting shift to virtual engagement, the use of patient technology and telemedicine has significantly increased during the pandemic.  

But how do patients feel about this change to a more remote healthcare model—particularly when it is part of a clinical trial? Is the added technology beneficial to patients, or is it creating more burdens for them? Are patients satisfied with the remote care they are receiving, and do they consider it to be “as good” as their previous in-person care? 

Patient Advisory Boards (PABs) provide the perfect opportunity to gain rich insights on these very topics. The valuable feedback from PABs can be used to inform protocol designs and patient engagement strategies, ultimately improving the overall experiences of trial participants.  

CISCRP has conducted several PABs over the past year. We have found that a number of common themes have arisen regarding perceptions of remote patient technology and telemedicine in clinical trials:  

  • Instructions and Training on Technology Use: Providing patients with clear instructions and training on the use of any technology or device is critical to ensuring a positive experience. Instructions should be provided in multiple formats (e.g., text instructions, video instructions) and be made readily available to patients (e.g., on a computer or mobile device, as a hard copy, etc.). People also prefer to have some indicator from the technology or device that they are using it correctly. This helps them feel confident that they are taking the appropriate steps in self-management of their care. 
  • Convenience and Quality: Many people appreciate the convenience of telemedicine and remote assessments that can be done from the comfort of their home.  However, many still prefer to have a choice between virtual or in-person appointments, as some perceive virtual appointments to be less thorough and not an accurate way to get a diagnosis. This is particularly true for conditions that present with more visual or tactile symptoms (e.g., dermatological conditions). 
  • Accessibility Factors: It is important to be aware that geographical and socioeconomic factors may affect ability to use telemedicine or patient technology. Many patient-facing technologies require a stable internet connection, creating access issues for those who live in rural locations or are unable to afford internet service. Shipping of devices could also be challenging for those living in rural areas. 
  • Privacy Concerns: When it comes to using technology as part of medical care, people have major concerns about data security and privacy. Additionally, some may not have a private location in their home for attending telemedicine appointments. It is important for researchers to be transparent and to clearly communicate the data protection measures that are in place. Patients should be aware of how and with whom their health information is being shared. 

Given the changes to the clinical trial landscape and the pace of technological advancements that we have seen over the past year, soliciting patient feedback has never been more important. Patient Advisory Boards offer a practical way for industry to keep a pulse on patient needs and preferences. 

Click here to learn how a CISCRP Patient Advisory Board can help your organization gather important patient insights.  

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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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