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 [email protected] 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 [email protected].

Written by Jay Matthews, Business Development Executive

Medical Hero Spotlight: 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

Journey to Better Health Mobile Exhibit Continues on its National Tour

The next generation of The Journey to Better Health mobile exhibit is en route to Atlanta, Charlotte, and New York City this summer and fall, with national support from the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). This exhibit is traveling to community events and health fairs, is highly interactive, and is custom-tailored to the communities that it visits.

A growing body of research shows that there are significant disparities in clinical research literacy among minority and underserved communities. Research also shows that the way to reach these communities is to meet them where they live, with local ambassadors to guide them to appropriate educational resources.

In 2018, CISCRP and Janssen tested a new grass-roots outreach program in Los Angeles and brought a traveling exhibit to large community events. Our Journey to Better Health RV contained interactive, educational displays about the clinical research process and its advances in medical knowledge. The RV also provided information for individuals interested in learning more about the clinical research process and participation. Multi-lingual clinical research “navigators” traveled with the RV to answer questions and guide visitors. This engagement campaign culminated in a live AWARE for All: Clinical Research Educational Event with free health screenings, resources, and speakers.

Throughout the process, CISCRP gathered impact measures and continues to learn more about the importance of bringing customized education directly to diverse communities. The RV helped to spread awareness and encourage attendance. CISCRP saw significantly higher numbers of attendees at the AWARE – LA Event and we continue to receive positive feedback from our visitors and requests to bring this traveling educational exhibit to new communities. CISCRP received media coverage that extended our reach and has garnered recognition by the health education community, and we were honored by clinical research professionals at the SCOPE conference as the winner of the Participant Engagement Award.

Building upon momentum generated in 2018 and 2019, CISCRP is establishing a consortium of 7 – 10 companies to support the Journey to Better Health engagement campaign over a five-year period (2020 – 2025). We’re hopeful that an educational grant from this consortium will enable CISCRP to produce and implement five AWARE for All: Clinical Research Education Events supported by the Journey to Better Health mobile exhibit per year. Companies participating in this educational consortium will receive prominent visibility and exposure. They will also participate in a steering committee to help identify target cities, monitor progress, and help continuously improve the campaign.

Three companies have already committed to joining the consortium. We invite other companies interested in playing a leadership role in providing education and increasing clinical research literacy among minority and underserved communities to contact us. Please email [email protected] to learn more about how to participate as a sponsor, navigator, or visitor!

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

CISCRP Establishes Health Communication Services

For the past eight years, CISCRP has been assisting more than several dozen pharmaceutical and biotechnology companies in preparing and disseminating plain language clinical trial results summaries. During that period, a growing number of companies, government agencies, institutions, foundations and patient advocacy groups have asked CISCRP to assist them in developing a variety of clinical research and health-related communications in plain language. In recognition of this expanded activity, CISCRP announces that all of its plain language projects and editorial activities will be subsumed under the newly created Health Communication Service department.

CISCRP is well positioned to meet this growing demand given its deep knowledge of the clinical research process and nearly 20 years of experience educating and engaging patients and the public. Global interest and momentum supporting plain language communications has also increased. The European Union Clinical Trials Regulation 536/2014, for example, now encourages sponsors to support lay language communications to ensure that patient and public needs are best met. And the Food and Drug Administration now requires informed consent documents to be written in plain language.

CISCRP’s Health Communications Services team assists organizations with not only plain language clinical trial results summaries but also informed consent documents; risk management communications; marketing and promotional messages; print, digital and web-based content; legal agreements; journal and publication abstracts and manuscript. As part of its plain language development process, all materials are reviewed and edited by the CISCRP team followed by review and modification from an Editorial Panel made up of patients, the lay public and other clinical research and health communication professionals.

We are truly excited about, and grateful for the growing role and impact of our Health Communications Services department. If you have any questions or would like to discuss a potential project, please contact Jay Matthews at [email protected].

Written by Jay Matthews, Business Development Executive

USA Today Supplement on Clinical Trials

CISCRP recently published another informative and educational clinical research supplement in the USA Today newspaper on June 7th. Running routine digital and print national media outreach across major newspaper outlets like USA Today, while simultaneously hosting our local events and community engagement efforts, allows CISCRP to have a maximum impact through frequent and consistent public awareness-building and educational messaging surrounding the topic of clinical research.

With ever-increasing interest in our “National Clinical Trial Outreach and Awareness Initiative” from key organizations and thought leaders in the industry, this particular insert grew beyond its usual 8-page spread to a 12-page spread to accommodate additional content. Reaching an audience of approximately 1.75 million people, with print markets in New York, Chicago, Philadelphia, Los Angeles, Phoenix, and Houston, as well as a digital publication, this biannually occurring campaign promotes greater public awareness of clinical research and reshapes perceptions surrounding participation in trials.

Contributions from Janssen, Pfizer, WCG, Eli Lilly, Bristol-Myers Squibb, Biogen, and Merck made for a well-rounded collection of articles and advertisements covering various topics relevant to clinical research. CISCRP’s founder, Ken Getz, dedicated his foreword to “Medical Heroes”, acknowledging their investment in medical science and the future of public health. Additionally, we worked with our publisher, Media Planet, to create a helpful infographic, “What to Expect From Your First Clinical Trial,” to guide patients who are considering participation in a trial but don’t quite know what to anticipate. Another article that CISCRP included in the supplement explored the alternative options, specifically compassionate use and right to try, for patients who do not meet the requirements and are therefore ineligible for enrollment in an available clinical trial. On the back cover of the insert, CISCRP placed a newly designed “Thank You to Medical Heroes” advertisement, supported by all of the campaign sponsors as well as Allergan, PMG Research, Segal Trials, and Praxis. Our cover story focused on Jillian McNulty, a 43-year-old exemplary clinical trials volunteer and determined advocate for cystic fibrosis.

We will be publishing our next clinical trials supplement in December of 2019. There will be opportunities for sponsoring companies to contribute advertisements and/or editorial content. Contact Kat Marriott, [email protected], for sponsorship options and for the chance to partake in the development of the next educational supplement.

Written by Kat Marriott, Marketing and Communications Coordinator

From the Editor—June 2019

June was a big month for us here at CISCRP. Not only did we exhibit and present at the DIA Global Meeting in San Diego, but we also underwent some changes to our organizational branding. We are proud to roll out some new service names, logos, and a remodeled website to present a look and feel that best represents everything we do at CISCRP.

In this issue, you’ll read about how our Communicating Trial Results team has become Health Communication Services to reflect their ever-expanding programs and offerings. We also now refer to our Events team as Community Engagement—events are only a part of all the amazing work they do.

You’ll also begin to notice something we call our International Education & Awareness program. This department is responsible for our groundbreaking insertions in USA Today that raise awareness about clinical trials. In addition, we are also launching a new minority media channel to raise clinical research literacy within underserved communities. International Education & Awareness also includes our Education Center media, Content Licensing, and Mass Media Consulting programs.

The most noticeable visual change you’ll see is with our CISCRP website. The design, look, and feel have been renovated to reflect our new branding. Moreover, visitors will have a much cleaner user experience navigating through our site. We encourage you to send us your feedback.

New branding isn’t worth anything, however, without real substance behind it. That’s why, at CISCRP, we continue to provide valuable programs to help engage the public and patients as partners in the clinical research process. We also strive every day to come up with innovative ways to reach and help more people. You’ll read about some of these services in this issue of our newsletter—from our Patient Advisory Board conducted in Taiwan, to our 2nd Annual User Group Meeting, to the exciting national tour of our next-generation Journey to Better Health mobile exhibit.

Finally, please be sure to read our Medical Hero Spotlight about an extraordinary woman serving those in the HIV/AIDS community of Baltimore. Her story is inspiring. It reminds us why we go to work, and why our mission is so important.

Written by Jim Keen, Associate Director of Marketing, Promotion, and Outreach

Melinda Bachini: How Clinical Trials Gave Her Hope

In 2009 Melinda was a paramedic, wife, and mother of 6 when she began experiencing discomfort, which she initially attributed to the hectic nature of her job. However after discussing her symptoms during a routine check-up her doctor decided to order an ultrasound. It was at this time that a mass was found on her liver. Then on December 1, 2009 Melinda was diagnosed with Intrahepatic Cholangiocarcinoma.

Cholangiocarcinoma, otherwise known as bile duct cancer, is not only rare but difficult to treat. The main form of treatment for patients is often surgery. Initially Melinda was told the tumor was confined to her liver so, a mere 20 days after her diagnosis, she underwent a procedure to have two-thirds of her liver removed. Just a year later, the cancer spread to her lungs. Melinda was now a stage 4 terminal cancer patient.

It was at this time that she took a more active role to learn about her options. Her doctor suggested a clinical trial. Unfortunately she soon found out that, although the drug would have been provided free of charge during the trial, her health insurance would not cover the costs of the trial’s standard care, such as blood work and scans. In June of 2010 Melinda went forward with a treatment plan that involved chemotherapy. Her first round lasted a period of 6 months. During this time, her cancer spread back to her liver, and she continued treatment for another 6 months. Ultimately, as her symptoms grew worse, she decided to stop chemo. Melinda recalls, “It was a hard decision because I didn’t want my children to think I just gave up. But my quality of life was just so bad.”

At that point Melinda mostly stopped looking for clinical trials. She found that while there were active trials, many involved chemo. However upon speaking with her oncologist she became aware of a clinical trial in Maryland at the National Cancer Institute. The month-long trial was federally funded and involved surgery and adoptive cell therapy. Melinda enrolled in the trial in March of 2012. She relates the remarkable change she experienced upon completion of the trial. “Before the trial I had so many tumors on my lungs that I couldn’t walk without coughing. But after the trial I started feeling so much better.” Remarkably she was the first person in the trial to have a positive response.

Melinda spent the next 18 months with no other treatments. But over time, tumors started growing again. At this time researchers decided to take a different approach using one of her T cells. Months later she reported feeling much more active. Melinda spent the next 3 years without treatment until ultimately having to undergo surgery to remove tumors on her right lung. Although not officially able to declare herself in remission, she credits her survival to clinical research.

Often when people are first diagnosed, Melinda shares, they feel like there is no hope. But she points out the progress that has been made and the ongoing research being conducted. She emphasizes, “There are more options now than there were 9 months ago. We’re not going to get better treatments out there until clinical trials are done.” Today Melinda continues to share her story and provide support for others as an advocacy coordinator at the Cholangiocarcinoma Foundation. Looking back on her career Melinda says, “I loved being a paramedic, and I wondered, ‘Will I ever find anything I love as much again?’ And I did.”

Written by Leslie Perez, Marketing & Communications Coordinator

Honoring Christine Pierre’s Legacy at AWARE – Baltimore

“Advocate for Your Health” is the underlying theme for CISCRP’s upcoming AWARE for All – Clinical Research Education Day at Johns Hopkins’ Turner Auditorium on April 17. This three-hour program from 5:00pm – 8:00pm will feature free health screenings including HIV and Hep C, mental health, dental and oral, flu vaccines. Attendees will also have the opportunity to interact with research professional and clinical research study volunteer panelists from around the Baltimore area, and a diverse selection of community organizations exhibiting in the Information Alley.

This is a particularly special program to kick off the 2019 event repertoire as CISCRP is dedicating AWARE – Baltimore in honor of former advisory board member, Christine Pierre. Since our founding, Christine has been a passionate supporter of our mission: she served on our advisory board, was involved in our planning team for numerous events, and also personally encouraged industry professionals to support CISCRP’s programs and initiatives. She organized annual study volunteer appreciation events and donated proceeds to the AWARE for All educational initiative. A Medical Hero herself, she contributed tremendously to empowering patients as partners in the clinical research process.

Christine was passionate about and dedicated to communicating the essential role of investigative sites in the clinical research process and in every study volunteer’s experience. Christine and Ken Getz often shared the podium to advocate for this critical relationship. In an interview with PharmaVOICE back in June 2013 that shared the impetus behind launching the Society for Clinical Research Sites (SCRS), Christine stated, “The sites are the closest to the nucleus of this industry – with the center being the volunteers. Without sites there are no subjects, no data, no research, and no advancement of medicine…sites are the only place in the research ecosystem that have the responsibility and privilege of interfacing with volunteers.”

The AWARE for All event and grass-roots outreach campaign focuses on what sites are doing to ensure that patients feel like they’re a part of the team.  It also empowers the public with educational resources and tools to advocate for their health. We miss Christine greatly and are grateful for her tremendous contributions to the clinical research enterprise.

Details:

When: Wednesday, April 17, 2019
Time: 5:00pm – 8:00pm
Where: Turner Auditorium at Johns Hopkins University (720 Rutland Ave, Baltimore, MD 21205)
Cost: Free
Reserve Your Spot Here

Highlights:

  • Free health screenings
  • Free dinner
  • Presentations by researchers, medical professionals, and study volunteers
  • Networking opportunities among patient advocacy groups, community organizations, research centers and sites, academia, CROs, and sponsor companies

Written by Ellyn Getz, Senior Manager of Development and Community Engagement

 

 

From the Editor

With the advent of spring, I think many of us experience a feeling of hope that we won’t have to endure much more wintery weather.  Similarly at CISCRP, there is a sense of hope, but it is year round.  It’s a feeling that the work we do helps to make the world of clinical research a better place. 

Examples of this vibrant feeling permeate through this issue’s articles. In our Medical Hero Spotlight, we learn about the amazing and heartwarming story of Melinda Bachini—a wife and mother who is battling a rare disease, and who has fought it by volunteering in a clinical trial. 

In other articles, we spotlight how:  

  • The American Society of Hematology (ASH) Research Collaborative and CISCRP’s Research Services are working together to engage Sickle Cell Disease communities  
  • CISCRP’s Plain Language Services are critical and are helping the National Cancer Institute 
  • The late Christine Pierre’s legacy lives on in the organization she founded: the Society for Clinical Research Sites  

Christine was a passionate supporter of CISCRP’s mission and a driving force for greater research site sustainability.  Our upcoming AWARE for All Baltimore event is dedicated in her honor.  In addition, we are excited to announce the 3rd edition of Ken Getz’s book, The Gift of Participation.  This new volume contains important updates, as well as an even greater patient focus.  Finally, let me take a moment to congratulate the winners of our first annual virtual fitness challenge, the Medical Heroes Appreci-a-thon.   

Companies with the Most # of Teams:  
1st Place:  Syneos Health 
2nd Place:  Amicus Therapeutics 

Most Spirited Team:  
Mercy Research 

With so many advancements in modern health care and a greater commitment to patient centricity in clinical research, it’s hard not to have hope.  Please enjoy this issue of Partnering in Clinical Research 

Written by Jim Keen, Associate Director of Marketing, Promotion and Outreach