Supporter Spotlight: Biogen

Biogen has played, and continues to play, an active role in supporting CISCRP’s mission to educate patient communities about clinical trials. A host sponsor of our upcoming AWARE for All programs in Atlanta and Phoenix, their support has further demonstrated their commitment to improving disparities in clinical research literacy among diverse and underserved communities and building a foundation of support and access among minority health care providers.

Biogen’s work with CISCRP also extends to our Perceptions & Insights study, Health Communication Services, as well as Patient Advisory Boards (PABs) which further showcases their patient-focused culture and mission to deliver innovative therapies for people living with neurological and neurodegenerative diseases.

We met with Murray Abramson, MD, Vice President of Global Clinical Operations at Biogen and a major champion of these engagement efforts. Murray highlighted the importance of “stepping into the shoes of patients” to gain a better understanding of what matters to them. Murray shared one of his motivations with us, “It is absolutely imperative to reach out to people, particularly in disease areas where there aren’t good treatment options or perhaps not any treatment options at all.”

Biogen has also developed a number of meaningful, impactful, internal programs to promote patient engagement among staff. The team’s Tree of Hope, dedicated to Carol Seider’s memory, was prominently displayed with placards representing staff motivations on ways in which they can support patients around the world. Carol Seider lived her life dedicated to finding treatments and cures for patients in her role as Senior Director of Global Clinical Operations. She helped inspire Biogen to seek new ways to amplify the voice of patients in clinical research.

In addition, Biogen hosts an annual Patient Engagement Day to bring employees together across R&D to raise awareness about Biogen’s patient engagement efforts and ways to implement meaningful initiatives as a part of department-wide activities. Ken Getz shared CISCRP’s Perceptions & Insights data at a recent Patient Engagement Day that focused on building a sustainable and stronger engagement with underrepresented patient populations for clinical trials.

CISCRP is grateful for Biogen’s support of numerous patient engagement activities, which help to raise awareness, empower individuals and their families with education to allow for informed decision-making processes, and improve overall clinical trial experiences.

Written by Ellyn Getz, Associate Director of Development & Community Engagement

From the Editor

Dear Readers, 

Autumn is here and in New England, there is a crisp coolness in the air along with the leaves starting to turn colors of red, yellow and orange.  A beautiful time of year and a sign that 2019 is fast approaching its close.  Like many organizations, CISCRP is focusing and spear-heading several different initiatives with an eye towards 2020 planning.   

In this edition, Leah Crocker, our Medical Hero Spotlight, shares her journey with Lupus and Raynaud’s phenomenon, a common symptom of Lupus. Leah’s clinical trial journey began when relocating to a warmer climate, Georgia, and connected with a Rheumatologist, who encouraged her to participate in a clinical trial. 

In addition to Leah’s inspiring story, our Q3 newsletter features a variety of exciting articles covering key programs, events and initiatives supporting our mission of building awareness and education among diverse communities. 

The initiatives are in full motion with the AWARE for ALL events being hosted in Atlanta and Phoenix, the Journey to Better Health mobile, interactive exhibit ‘on wheels,’ to the 2019 Perceptions and Insights study where results are in and analyzed.  We are continually working with industry professionals on producing Trial Result Summaries to offer to patients who participated in clinical studies to help them understand the study’s outcome.  

A new initiative underway that we are very excited about is expanding clinical trial awareness and the importance of participation to diverse and underserved minority communities.  This new media awareness campaign is in addition to our annual National Clinical Trial Outreach and Awareness Initiative with the USA Today Supplement.   

I invite you to read the brief articles to learn moreshare your comments and to participate in the media awareness campaign.  

If you are in search of educational materials about clinical trial participation, please visit the CISCRP Store for brochures, posters and videos that can be used to educate patients about clinical research. Brochures may also be co-branded for use at research sites, healthcare forums, educational workshops or other events. Please contact me, jchambers@ciscrp.org, for details.  

As we enjoy Autumn, and all that it brings, we welcome the opportunity to assist you in further building educational and awareness programs around clinical trials to all communities.  Please contact us as you work on developing your end of year 2019 and 2020 plans.  

We look forward to seeing you at the upcoming industry events. Thank you for your continued support.  

Warm regards, 


Joan A. Chambers 
Senior Director, Marketing & Outreach 

Spreading Clinical Research Awareness to Diverse Communities

The Center for Information and Study on Clinical Research Participation (CISCRP) is launching a new educational campaign focusing on the importance of clinical research participation and diversity in clinical trials.  

As an extension of our ongoing semi-annual national media outreach program to recognize Medical Heroes and spread clinical research awareness in the USA Today newspaper, CISCRP has established relationships with five leading newspaper publishers serving diverse minority communities.  The new campaign will reach nearly one million people in African American and Hispanic communities in major cities throughout the United States during the month of November. These major cities include Atlanta, Georgia (Atlanta Voice Newspaper), Chicago, Illinois (Chicago Citizen Newspaper), Detroit, Michigan (Michigan Chronicle), Los Angeles, California (Excélsior Newspaper), and New York City, New York (New York Amsterdam News). 

Throughout the month of November, CISCRP will place a compelling and inspiring full-page, 4-color ad with thought-provoking copy in each of the newspapers—both print and digital.  The ad will highlight the need for diverse patient participation in clinical research in order to discover new therapies that are effective for all individuals.  

Collectively, we can raise public and patient awareness and education with the full-page ad and its powerful message, “Diversity in Clinical Trials Brings New Treatments to Everyone.” 

The campaign’s goal is aimed at building trust within diverse and underserved minority communities, breaking down the barriers, informing individuals about clinical research participation and the importance of diversity in clinical trials.  

CISCRP will be receiving support from various stakeholders in the clinical research industry who share the same passion and commitment to improving clinical trials and extending opportunities to participate in studies to underrepresented communities. This exciting campaign is just the beginning. OvertimeCISCRP plans to increase the scope and frequency of this diversity-focused initiative. We are hopeful that future participating sponsors of this important campaign will contribute their own educational content and utilize our media channels to share valuable information with underserved communities.    

To learn more or participate in this important initiative, please contact Kat Marriott at KMarriott@ciscrp.org. 

Written by Kat Marriott, Marketing Program Manager 

Leah Crocker: Lupus Advocate Shares Her Journey

Lupus is an autoimmune disease that causes your body’s immune system to attack your tissues and organs. Difficult to diagnose, Lupus can remain dormant in an individual’s body, only to be “woken up” by an illness or major surgery. This was the case for Leah Crocker. In 2000, Leah had just undergone carpal tunnel surgery on both hands but wasn’t healing properly. At this time, her orthopedic surgeon suggested she consult a rheumatologist. Upon seeing a rheumatologist her blood work came back positive for Lupus.

A disease with no cure, Lupus is managed through treatments that help patients control their symptoms. Soon after her diagnosis Leah began experiencing numbness in her fingers. This issue was identified as Raynaud’s phenomenon, a common symptom of Lupus. Raynaud’s is a condition that results in the discoloration of the fingers and toes in response to cold temperature or stress. During this time, Leah was prescribed an anti-malaria drug to help. However, her condition would soon grow worse when she discovered that gangrene had set into two of her fingers. At the time she had a choice between amputation or chemotherapy. Leah chose to undergo chemotherapy, which she continued for several years.

Despite undergoing treatment for Raynaud’s, because of the severity of her condition her rheumatologist strongly recommended that she relocate to a warmer climate to reduce the chances of her condition worsening. For Lupus patients in similar situations Leah advises, “Know your limitations and live within them.” So, in 2007 she made the move from her home state of New Jersey to start a new life in Georgia. After relocating to Georgia Leah connected with a new rheumatologist Sam Lim at Emory University School of Medicine.

This is when her clinical trial journey began. Leah credits Dr. Lim for encouraging her to get involved in clinical trials. The first study she joined was The Georgians Organized Against Lupus study, led by Dr. Lim at Emory University in 2013. The goal of this study is to better understand the burdens of Lupus. Leah has been involved in this study for the past several years, participating in in-person visits once a year and completing an online questionnaire twice a year. Leah also participated in another trial for Raynaud’s in 2015. This trial was studying the effects of Botox on individuals with Raynaud’s. As part of the trial she was asked to hold her hands under cold water and receive Botox injections. Despite the challenging experience, Leah is happy to have participated in this trial.

An experienced clinical trial volunteer, Leah’s advice to those thinking of participating is, “Just do it.” At the time of her diagnosis there were fewer medications available for individuals like Leah. Today, thanks to clinical trial volunteers, there is newfound hope for the Lupus community. To find trials for Lupus in your area visit CISCRP’s Search Clinical Trials page. For more information about Lupus, treatments, clinical trials, community forum and other educational information, please visit www.lupusresearch.org

Written by Leslie Perez, Marketing and Communications Coordinator

Traveling Exhibit Tour Begins: CISCRP’s Journey to Better Health

A first-of-its kind educational and recreational vehicle equipped with interactive tools, healthcare information and relevant resources, insightful study data and knowledgeable experts well versed in the clinical research industry 

Starting this month, September, the Journey to Better Healthmobile exhibit on wheels’ is traveling to diverse communities across Atlanta, Chicago, New York, Newark and Long Island, stopping at public schools, museums, libraries, community and senior centers, places of worship and free public-health expo’s 

Community members are invited to walk through our educational exhibit and learn about the clinical research process through a variety of stations focusing on: 

  • Why diversity is important in clinical research 
  • A timeline of advancement in public health 
  • Study volunteers and their experiences 
  • Resources & take-aways for individuals interested in clinical research participation  
  • Questions about eligibility criteria and the informed consent process in order for individuals to make informed decisions about clinical research participation 
  • Potential risks and benefits 

The CISCRP team trains representatives from each host community – our clinical research navigators — to answer questions, address concerns and serve as personal guides throughout the exhibit. This vehicle continues to pick up momentum as a customize, engaging experience that not only educates but also demonstrates the value we place on the public as partners in the clinical research process. 

The program was recently recognized with SCOPE’s Participant Engagement Award and nominated with CARE’s Medidata Clinical Partnership of the Year as a new benchmark in partnering through collaborative clinical trial activity.  

We’re grateful for Janssen Research & Development, Pharmaceutical Companies of Johnson & Johnson’s continued support for expansion as we visit 15 events this fall and bring the traveling exhibit vehicle to five new cities per year over the next five years as part of our Journey to Better Health consortium. 

Over the fall season we traveled to and continue to travel educating and spreading clinical trial awareness: 

Atlanta 

Chicago 

New York 

Mark your calendars and share these dates with colleagues, friends, and families.  We look forward to seeing you. For more information on these events, please contact Ellyn Getz at ellyngetz@ciscrp.org 

Written by Ellyn Getz, Associate Director of Development & Community Engagement 

CISCRP’s 2019 Perceptions and Insights Study

It is hard to believe two years have passed since CISCRP’s last Perceptions & Insights Study. We are excited to announce the 2019 study results are in! Over 12,450 people from around the world provided their opinions on various aspects of clinical research this year revealing significant new insights on patient engagement preferences.

Since 2013, CISCRP has conducted the Perceptions & Insights study on a biannual basis in order to monitor trends and identify opportunities to better inform and engage the public and patients as partners in the clinical research enterprise. Annick Anderson, Director of Research Services, notes, “The 2019 Perceptions & Insights Study offers the most comprehensive look to date at the ideal clinical trial experience from the global public and patient perspective – allowing stakeholders to model their patient engagement strategies most effectively around these patient needs.”

The 2019 study captured the experiences of over 3,600 study volunteers across diverse therapeutic areas, a significant jump from the 2,000 responses collected in 2017. The results continue to support that study volunteers generally have positive experiences, with 45% rating the care and attention they received during the trial as better than the care they would have otherwise received.

Did you receive any reports or updates on the results of the study 
once you completed the clinical research study?

Year Yes No
2017
36%
64%
2019
39%
61%


Sample size: 
1,828 in 2017; 3,054 in 2019.   
Base: respondents who participated in clinical trial, excludes “don’t remember” 

Similar to 2017, a significant percentage (96%) would be willing to participate in another study in the future – which is another strong indicator of overall satisfaction. However, areas of improvement remain, for example – a large proportion (39%) of study volunteers reported not ever hearing anything back from the site or the sponsor after their participation ended – demonstrating that post-participation engagement activity should be an area of focus for stakeholders. The study additionally takes an in-depth look at the burden of participation and identifying areas where attention is needed – for instance, close to 50% of clinical trial participants reported traveling at least 30 minutes or more one-way to the study clinic for their visits.

A preliminary review of specific sub-groups—such as minority populations and their motivations to participate in a clinical trial– shows that populations of African descent were significantly more likely to find it “very important” (73%) for their primary care physician or specialist to be aware of clinical research studies being conducted in their communities compared to their Caucasian counterparts (67%). This finding highlights the importance of enabling local health care providers to discuss clinical trial opportunities with their patients and driving inclusion of minority populations in clinical trials. Potential costs and reimbursements associated with clinical trial participation, as well as compensation for time-off from work were also particularly important to this patient population.

To access insights and findings from this recent study, visit CISCRP’s Perceptions and Insights webpage. The 2019 reports will be posted and available for download this Fall. These are available free of charge, however, interested parties are encouraged to provide a donation for the reports. CISCRP will also be presenting the results of the Perceptions & Insights study at industry conferences, company meetings, and other forums in the coming months.


Written by Jasmine Benger, Senior Project Manager of Research Services

CISCRP is Expanding its Patient Communication Services

As many of you know, for nearly ten years CISCRP has been helping pharmaceutical and biotechnology companies translate complex technical clinical trial results summaries into non-technical, easy-to-understand language for patients and the public.  For all trial results summaries, CISCRP turns not only to its extensive plain language writing expertise but also its unique editorial input panel comprised of patients.

During the past 24 months, CISCRP has seen growing interest in applying its editorial input panel and plain language expertise to other health education and communication areas. CISCRP has been working on numerous “special” projects including the translation of informed consent documents; legal and regulatory documents for patients and their families; website content; abstracts for journal submission; manuscripts; and clinical trial finders among other initiatives.

Many patients and caregivers have told us how much they value and appreciate reading clinical research information prepared by CISCRP.  Plain language health communications give them greater comfort and confidence in understanding their medical condition and how investigational treatments are working, and in making informed decisions about participating in a clinical trial.

If you would like to participate on our editorial input panel, please let us know by calling 617-725-2750 or visiting our web site, https://www.ciscrp.org/services/health-communication-services/.

And if you are an organization interested in collaborating with CISCRP to prepare plain language health communication for your patients and their families, please give us a call at 617-725-2750 or email info@ciscrp.org.

CISCRP Conducts its First PAB in Asia – Best Practices for Conducting PABs Abroad

CISCRP Conducts its First PAB in Asia – Best Practices for Conducting PABs Abroad

Since 2011, CISCRP has been collaborating with sponsors on Patient Advisory Board (PAB) meetings to give patients and their caregivers the opportunity to share personal experiences and thoughts on ways to optimize clinical trial designs. While PABs have routinely been used as a patient engagement tool in the US, Canada, and Europe, PABs conducted in Asia are much less common due to various reasons – including language barriers and challenges navigating local ethics committee processes and regulations. In April 2019, EMD Serono and CISCRP held what they believe to be the first-ever Patient Advisory Board meeting in Taipei, Taiwan, and the success of this milestone exemplified CISCRP’s knowledge of the conduct of global patient engagement activities.

To plan and execute a successful global PAB, CISCRP recommends the following best practices:

  • Anticipate differences in local regulations and ethics review processes
    Each PAB CISCRP conducts undergoes an ethics review as an added layer of oversight, and in the United States, this process is generally fast and straightforward. Yet, identifying an ethics committee in other countries that will conduct a review of a patient advisory board meeting may prove to be a challenge, particularly when they may not be familiar with PABs. As such, CISCRP suggests working alongside a local non-governmental organization (NGO) to help support the submission process.
  • Have patient-facing materials translated by an organization based in the country where the PAB will be held
    As there may be nuances in the local language, having native speakers translate any patient-facing materials can help to ensure that key messaging sponsors wish to receive feedback on does not get “lost in translation.”
  • Be aware of local healthcare dynamics
    In countries where patients heavily respect doctors, and due to unfamiliarity with PABs in other regions, engaging a doctor from a local and relevant health NGO to introduce the research activity to prospective patient advisory board members can help establish trust and ensure that the purpose of the PAB is communicated effectively.
  • Find a moderator who speaks the native language and has sufficient knowledge of healthcare
    This assures that the patients can not only have a deeper conversation about how to improve clinical trials for their condition, but a moderator also helps with communication of meeting logistics with patients before the session. If the project team does not speak the local language, using a simultaneous translator and headsets can make the meeting more engaging for these individuals.

Through CISCRP’s experiences with PABs both domestically and abroad, we have learned that it is critical to not only put together PABs so that sponsors can adapt their clinical trial designs to their population of interests’ needs, but that we must also adapt our own approaches to research so that we can most effectively and conscientiously do our job in a country where we are a guest. Are academics and researchers in the country already familiar with PABs? Are there cultural considerations that we should be aware of as we embark on our mission to ensure that patient voices are heard? These questions and the above best practices can help sponsors strategize a plan to most effectively conduct a PAB in new territory.

If you are interested in conducting a PAB or would like to learn more about other services offered by CISCRP’s Research Services team, please feel free to contact Annick Anderson, our Director of Research Services. She may be reached at AnnickAnderson@ciscrp.org or by phone at 617-725-2750 x400.

Written by Nova Getz, Research Associate

CISCRP Hosts the Second Annual Plain Language Clinical Trial Summaries User Group

On May 2, 2019, CISCRP had the privilege of hosting its 2nd Annual User Group Meeting focusing on best practices, lessons learned and ongoing challenges associated with the return of plain language clinical trial results summaries.

The meeting was held at CISCRP’s Liberty Square office in Boston. Attendance in the 2nd Annual User Group Meeting increased over last year’s first meeting. Representatives from a dozen pharmaceutical and biotechnology companies participated in the group discussion including AstraZeneca, Biogen, CSL Behring, EMD Serono, Novartis, Otsuka, UCB, and Vertex Pharmaceuticals.

The User Group Meeting provides an open forum for information sharing and discussion. Meeting participants exchanged ideas and experiences and also provided CISCRP with valuable insights into opportunities to continuously improve on its plain language services.

We want to thank all of the attendees again for their time and participation in the 2nd Annual User Group Meeting. It was a pleasure for CISCRP to host and facilitate this event. CISCRP hopes to continue to see the User Group grow and offer even greater value to participating companies in the coming years.

If you would like to learn more about joining our Plain Language Clinical Trial Summaries User Group, please contact Jay Matthews at jmatthews@ciscrp.org.

Written by Jay Matthews, Business Development Executive

Gail Graham: Providing Hope for the HIV/AIDS Community in Baltimore

Most of us are familiar with the anxiety following a medical test; having to wait days, sometimes weeks for the results. In 1997 Gail Graham went to the doctors for a routine HIV screening and on April 29, 1997 her results came back positive. She was shaken to say the least. As a mother of two young boys, her first thought was, “I just want to live long enough to see them graduate.”

The stigma of having HIV is something that has affected Gail’s life in many ways. Following her diagnosis, she reveals how some of her family members began treating her differently – even going as far as forcing her to use paper plates and cups. However, she also shares her gratitude for her family and friends who chose to educate themselves about HIV. She proudly notes how her two sons speak openly with their peers about HIV.

Gail also explains how her religious faith has changed over the years. She was raised a Jehovah’s Witness but had since stopped practicing. However, in 2006, with the encouragement of her best friend, she attended a church service at Mt. Lebanon, a Baptist church in Baltimore, Maryland. After the service, Gail was interested but hesitant in joining the church. “I was afraid that if my diagnosis became public, somehow it would make the church look bad,” she explains. Gail made a request to speak with the church’s pastor, Reverend Franklin Lance. She recalls Pastor Lance’s heartfelt and welcoming words: “’Gail this is your ministry.’” In the years since that conversation, with the support of her pastor, Gail has taken an active role at church. As the Director of HIV/AIDS Outreach Services and Ministry, she has created a much-needed safe haven for community members to receive free confidential HIV screening and counseling.

Gail’s role at Mt. Lebabon has enabled her to connect with various local churches and organizations. She stresses the need for services in her community, due to the high rates of HIV/AIDS in Baltimore. But, she also shares her initial hesitancy in working with all groups saying, “We had a lot of people coming to our community and not giving anything back.” So, when Gail was invited to an event held by the PATIENTS Program at the University of Maryland School of Pharmacy, she was reluctant. However, due to their persistence in collaborating, she invited members of the program to exhibit at Mt. Lebanon’s World Aids Day event. Gail shares her surprise upon witnessing the way they engaged with community members. She notes, “They were not only talking to people, but holding their hands.” This simple gesture is something that she says professionals often lack when counseling individuals who are HIV positive.

Gail’s journey also led her to become involved in clinical research. In March of 2014 she joined an HIV/AIDS clinical trials group at Johns Hopkins University. This gave her an opportunity to learn more about ongoing research, but she had a desire to do more. “How can I be on this board but not be a part of research?” She spoke with her doctor who recommended a trial at the National Institutes of Health. Gail recalls her experience as a very positive one and how the research staff made her feel valuable. In addition, she learned many new things about her disease from the study findings. Although the trial ended early because the medication was not effective, Gail says, “I would gladly do it again.”

Today, thanks to advances in medical research, Gail is happy to report that her disease is undetectable and untransmittable. To others diagnosed with HIV she stresses, “It’s just a diagnosis; it’s not you. You can still live a long and healthy life.” To learn more about Mt. Lebanon’s HIV/AIDS ministry click here. To find clinical trials in your area fill out our Search Request Form.

Written by Leslie Perez, Marketing and Communications Coordinator