By Shelly Reese

In 2004, five days after giving birth to her third child, 36-year-old Rhonda Monroe nursed her newborn daughter, laid her in her cradle, and suffered a massive heart attack.

“I felt like an elephant was sitting on my chest,” says Rhonda, who was living in Charlotte, NC at the time. “I vomited and called 911.”

Despite Rhonda’s classic symptoms and a confirming EKG by the paramedics, doctors did not diagnose her condition for nearly a week.

“I kept telling them. ‘I’m having a heart attack,’ but I wasn’t an overweight middle-aged white guy, so they kept saying, ‘You can’t be having a heart attack.’”

A second EKG ultimately showed Rhonda was indeed experiencing a heart attack and further examination showed why: five of her coronary arteries had dissected. Blood was leaking through tears in the layers of her artery walls and the trapped blood was causing the artery walls to bulge inward, constricting the flow of blood to the heart.

Rhonda underwent a quadruple bypass and later had a defibrillator implanted, but she continued to suffer from chest pain and poor circulation. In February 2005 she went to see a heart specialist in Washington, DC only to discover she had congestive heart failure and her arteries were once again blocked.

“They said, ‘There is nothing we can do and nobody is going to operate on you because you are too high a risk,” she recalls. Rhonda laid in MedStar Washington Hospital Center for several weeks trying to convince doctors she should be a surgical candidate. In the midst of her lobbying efforts, Dr. Lowell Satler approached Rhonda with the opportunity to participate in a clinical trial exploring whether a Cypher drug-eluting stent could benefit patients who had already undergone bypass surgery.

Having suffered adverse reactions to heparin and some other heart medications, Rhonda had concerns about the use of a drug-coated material but was none the less eager to participate in the trial.

During her months-long recovery from bypass surgery she had learned a lot about heart disease and clinical research.

“I did as much research as I could so I could be a well-informed partner in my healthcare, and what I learned is that women aren’t invited to participate in clinical trials as often as men. That helps explain why when I went to the hospital in 2004 they didn’t take me seriously. I had a classic Hollywood heart attack, but nobody paid any attention because I wasn’t a middle aged white guy. So when I had a chance to participate in a trial, my attitude was, ‘Pick me! Pick me!’ I participated because I didn’t want anybody else to be turned away the way I had been.”

The trial involved undergoing a balloon angioplasty in which two stents coated with anti-rejection medication were inserted into Rhonda’s heart to provide a scaffolding that would hold the arteries open. Afterward she would take Plavix for a year and undergo monitoring. Unfortunately, the surgery did not improve Rhonda’s ejection fraction — a measure of the heart’s pumping efficiency – or ease her pain.

Fortunately for Rhonda, although the stents failed, her persistence won over Dr. Steven Boyce, who ultimately agreed to perform a complicated surgery that involved a repeat bypass procedure, surgical ventricular reduction to remove a damaged section of her heart, and transmyocardial revascularization, which involved drilling 15 holes in her heart with a laser to promote additional blood flow.

The surgery worked. Today Rhonda, who now lives in Bethesda, Md., is an advocate for women’s heart health and patient education.

Looking back on her experience with clinical research, Rhonda has no regrets about participating in a trial and advises others to consider doing the same. “Do your research and, if you think it will work for you, get involved. Even if it doesn’t benefit you personally, the information helps others.”

By Rachel Minnick

CISCRP’s many educational programs and initiatives are fueled by the dedication and involvement of our supporters and volunteers.  We are pleased to be spotlighting two of these supporters in this edition of the newsletter, both of whom made important contributions to our recent USA Today supplement on Clinical Trials. The supplement is part of our National Clinical Trial Outreach and Awareness Initiative and we caught up with 2 of our top sponsors – Biogen and TransCelerate Biopharma Inc. – to find out what drives their company’s passion for clinical research education and awareness. We asked each one to comment on their company’s commitment to raising public awareness about clinical research and how this fits into their organization’s overall mission.  We also asked what other specific initiatives – in addition to supporting CISCRP’s National Outreach Campaign – that their companies are working on at this time to raise awareness about clinical research.

Biogen

Biogen develops medicines for debilitating medical conditions with the goal of making a meaningful difference in patients’ lives.  Patients are at the center of everything we do here at Biogen.  Clinical research is a critical part of getting meaningful therapies to patients around the world, so it is important we partner with CISCRP and other companies to raise awareness of opportunities to participate in clinical research. We truly appreciate and thank clinical research participants and their families for their enormous contribution in helping to advance medical research and discover potential new treatments.

In addition to supporting CISCRP’s National Outreach Campaign, Biogen has developed educational tools as part of our commitment to raising awareness of clinical research and making information more accessible. Biogen has created videos, booklets and clinical research study websites that explain what clinical research is and what participation means for patients and families.  Furthermore, in order to help inform and educate patients about the clinical trials in which they participate, Biogen is committed to provide a factual summary of clinical trial results in plain language and make the summaries available to research participants at the end of the study. Biogen continues to seek partnerships and novel ways in which we can meaningfully engage the public on the topic of clinical research and provide helpful information to patients and families.

One of the pioneers in biotechnology, Biogen today has the leading portfolio of medicines to treat multiple sclerosis (MS), has the first and only approved treatment for spinal muscular atrophy (SMA) and is at the forefront of research into new medicines for neurological and neurodegenerative conditions. Led by world-class research and development, Biogen uses novel science and leading-edge technologies to create, commercialize, and manufacture transformative therapies for patients with few or no treatment options.  For more information, visit www.biogen.com.

TransCelerate Biopharma Inc.

As an industry, we have an opportunity to improve the links between clinical research, the public (patients, and their care-givers), and health care delivery (point of care/HCPs). Today, the role and potential impact of clinical research is not broadly known, and misconceptions and mistrust surrounding clinical research persist. There is low engagement with clinical research, low consideration of clinical trials as a care option, and an overall disconnect between available clinical trials and potential participants.  Individual pharmaceutical companies are making investments to engage with communities, attempting to build awareness, and developing recruitment campaigns for clinical trials. We believe we can have much bigger impact by pooling our efforts together to influence sentiment and understanding of clinical trials more broadly. This can have a substantial ripple effect on the clinical research enterprise.

Our mission is “to collaborate across the global biopharmaceutical research and development community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high quality delivery of new medicines.” Critical to the development of innovative new therapies, are trial participant volunteers, and a shared understanding in the public of the value medicine research and development brings to our society.

We envision a future in which key stakeholders are better informed about clinical research, and recognize it as a critical component of advancing population health. A future where there is increased discussion of clinical trial options between HCPs and their patients, and information about clinical trial options is available in clear and straightforward language.  We want to inspire and equip healthcare professionals to engage in more frequent and more fulfilling conversations with patients about clinical research and clinical trial options.

TransCelerate BioPharma Inc. was launched in 2012 as a non-profit organization to improve the health of people around the world by simplifying and accelerating the research and development of innovative new therapies.  For more information, visit www.transceleratebiopharmainc.com.

We want to thank Biogen and TransCelerate for their dedication to CISCRP’s mission and for helping to create awareness about the importance of clinical research.  Be sure to check out the USA Today supplement on Clinical Trials HERE!

We will spotlight a different supporter or volunteer in each Newsletter, so stay tuned for new features each quarter.

By: Leslie Perez

An important part of CISCRP’s mission is to gain a better understanding of public and patient perceptions of clinical research in an effort to improve trial volunteer participation and experience. It is for this reason that CISCRP’s Research Services team has developed a global survey to gather perceptions and insights data about patient experiences. The study has been conducted in 2013 and 2015 and is currently being conducted again in 2017.

To ensure the effectiveness of each survey, CISCRP’s Research Services team receives input and support from various organizations and investigative sites, and has the survey reviewed by an ethical review committee. The survey design also received input from the public, patients, and patient advocacy groups.  The survey consists of a series of questions which inquire about an individual’s clinical trial experience in addition to overall general perspectives on clinical research. Early indications are that the number of responses to the 2017 study will come close to or match the unprecedented response to the 2015 survey, with an even more diversified regional representation.  For example, there is a substantially higher representation of Japanese respondents in 2017 – offering valuable little-known views on clinical research from this particular region.

Annick Anderson, Director of Research Services states, “The latest 2017 Perceptions & Insights study will reveal exciting new insights on various topics – including the perceived value of various patient engagement initiatives and overall receptivity to the integration of clinical research into clinical care.”

Insights from past studies in 2013 and 2015 have provided important feedback for research professionals who may be seeking better ways to educate the public and improve clinical trials for patients. Data from these surveys are summarized in a series of reports that focus on different topics such as public literacy, public perceptions, decision to participate, and participant experiences. The findings are explained through various charts, graphs, as well as key takeaways. The reports are made available for download and viewing on the CISCRP website.  Many research professionals will reference the survey data in their white papers, publications, and training activities.

As has been done in the past, findings from this year’s survey will be made available free of charge on the CISCRP website, however, a donation to CISCRP is always encouraged for downloading the reports.  CISCRP will also present the findings at conferences, meetings, and forums throughout the year.

By: Leslie Perez

In honor of Clinical Trial Awareness week this past May, CISCRP worked with INC Research to develop an online animation to highlight the impact of clinical research. CISCRP previously collaborated with INC Research, in 2016, to host the “Inspiring Hope” Ideathon event, held to develop innovative ideas for raising awareness about clinical research. In hopes of continuing this awareness-building effort, the two organizations continue to brainstorm new ways, such as creation of this animation, to raise awareness of the role clinical research plays in public health.

The animation, titled “The Impact Clinical Trials Have on All of Us,” found on the CISCRP Homepage and CISCRP’s HealthUnlocked Community, begins by asking viewers to consider how healthcare products became available to the public. The video then encourages individuals to think about the role clinical trials play in the development of new medicines, devices and therapies.  It emphasizes that for each healthcare product currently available, there are millions of clinical trial volunteers who made these possible through their participation in clinical research. The video honors the role volunteers play in the development of seemingly basic medicines that help relieve the occasional headache to life-saving treatments for cancer patients. The role these individuals play in clinical research is one that CISCRP recognizes and honors through our Medical Heroes Campaign. This animation compliments this campaign and brings to light the need for greater awareness of the impact clinical trials have on all of us.

The intent of this animation is to reach new audiences and educate them about clinical research. The animation is available online, making it simple and easy for public viewing and sharing. We encourage research sites, patient organizations, and the general public to share this video with their communities to spread greater awareness of the impact of clinical trials.

This animation was a natural progression following our collaboration last year with CISCRP on the “Inspiring Hope” Ideathon, a ground-breaking event aimed at generating unique and effective ideas that raise awareness of clinical trials and study participation,” said Clare Grace, PhD, Vice President, Site and Patient Access, INC Research.  “There is a critical need for a better understanding of what clinical trials are and why they are vital to the health and well-being of patients around the world, and this animation addresses those issues.  We’re excited to provide this imporant tool to clinical research sites and others interested in joining with us to build awareness.”

Watch the video on CISCRP’s Homepage, on INC Research’s YouTube page, or feel free to download and share across your networks at your convenience using the following link: https://vimeo.com/210954960/8483b479ab

To view other educational videos by CISCRP, please visit our Education Center.

By: Rachel Minnick

CISCRP has formally launched a new mass media campaign, The National Clinical Trial Outreach and Awareness Initiative that will reach millions of Americans to educate them about the importance of clinical trials and promote greater awareness of clinical research.  This initiative falls under our renowned Medical Heroes Campaign, a public service movement dedicated to engaging the public in thinking differently about clinical research.

As part of the new outreach and awareness initiative, CISCRP will be producing and distributing educational supplements in major national newspapers and publications in an effort to inform the public and patients about the clinical research process.

To kick off the initiative for 2017, we teamed up with several leading organizations including TransCelerate Biopharma Inc., Biogen, Merck, Pfizer Inc., Janssen Pharmaceuticals Inc., Segal Institute for Clinical Research, and Praxis to develop a supplement on Clinical Trials that was published in USA Today on May 12^th.  The supplement hit newsstands in a number of major cities including Boston, New York, Phoenix, Washington D.C., Baltimore, and Los Angeles and was expected to reach 20 million people through print and digital channels.

For this first edition of 2017, the Clinical Trials supplement included an advertisement thanking and honoring individuals, Medical Heroes, who have given the gift of their participation in clinical trials; a feature story about Jameisha Brown, a self-proclaimed “cancer thriver” and her experience with clinical trials; and a headline profile about T.J. Sharpe, a melanoma cancer survivor and clinical trial participant.  These advertisements and articles are not only educational, but also engaging and inspiring.

The supplement also included a forward by CISCRP’s Founder, Ken Getz, on “Why Patients in Clinical Trials Are True Medical Heroes” highlighting the importance of recognizing those who participate in research and an editorial by Ken titled “A Clinical Trials Guide for Patients” that includes practical information and facts about what a patient can expect when taking part in a clinical trial.

The supplement has gained a great deal of recognition across the industry and beyond for its’ informative and awareness-building content.  We are pleased to share that CISCRP’s thank you to medical heroes advertisement will be appearing in the upcoming “Mid-Summer Classic” MLB All-Star Game official souvenir program in July.  The program will be available for purchase during All-Star week at the Florida Marlins Park and the Miami Beach Convention Center.  In addition, the program will be available nationwide at newsstands, bookstores, mass and specialty stores, supermarkets, airports, and online at MLB.Shop.com.  The total readership for the program is estimated at 800,000 nationwide!  This is another opportunity for us to spread greater awareness of the importance of clinical trials and honoring medical heroes to an even larger audience.

We have plans to develop another clinical trials supplement, later this year, to be published in a different major national newspaper.  There will be opportunities for sponsoring companies to contribute advertisements and/or editorial content.  Contact Rachel Minnick, rminnick@ciscrp.org, for sponsorship options and for the chance to take part in the development of this next educational supplement.