Medical Hero: Nurse Katie Klatt & COVID-19

At the beginning of the pandemic in mid-March, Katie Klatt, a nurse on a COVID-19 infection control team, received the news that she had contracted the virus herself. “I wasn’t too surprised,” Katie said. “I kind of knew, but the actual confirmation was a little bit scary. It was early on so no one in the US really understood how bad it was.” A healthcare professional, Katie’s background includes working as a PICU nurse and she had just moved to Boston to pursue her Master in Public Health at the Harvard Chan School. Now fully recovered, Katie is a patient participant in a COVID-19 antibody clinical study. This is her story.

Katie contacted her primary care physician when she started having symptoms. “I was treated in two different ways. The first week I was seen via telehealth, and that was literally the same week that so many medical professionals and patients were turning to that option. My doctor was retiring, so I didn’t really have anyone following me. The onus was on me to check in and report my symptoms.” At the end of the first week, Katie was advised to be seen in person, at an urgent care clinic. However, being symptomatic, she could only be seen at the urgent care if she was a previous patient. Being new to the area, this was not the case. Her only other option was to go to an emergency room.

“At first, I didn’t think I was sick enough to go to the ER. I didn’t want to take an Uber and infect anyone else and I was too tired to ride my bike. So I waited until the Tylenol kicked in and walked 40 minutes to the hospital. At the emergency room, they were really well set up. When I walked in, people started to call ‘Rule out!’ which means a COVID-19 patient is entering the area, so people started to move away from me as I passed by. After I was seen, Security escorted me out the back door to protect other patients and staff,” Katie said.

The hospital pharmacy was closed, so Katie was handed a paper prescription to have filled elsewhere. Even though she was wearing a N-95 mask her mother had sent to her a few weeks before she got sick, Katie realized that she should not enter a store. She was also concerned about handing the paper prescription to a pharmacy technician. Katie called a friend who met her at the pharmacy with a clear plastic sandwich bag. She dropped the prescription in it and her friend brought it inside and had it filled.

In addition to having COVID-19, Katie also had a sinus infection. When she was diagnosed, Katie knew what to do. “Stay at home, isolate, hydrate and rest,” Katie stated plainly. “As a healthcare provider, we tend to minimize our own complaints because we’ve seen so much worse, so my view of it was skewed. Having a 103 degree temperature for 10 days, it was almost like I got used to having the chills and feeling exhausted constantly.”

Katie socially isolated from her roommates, staying in her room and only entering the kitchen when they were not present. “I had the presence of mind, despite the high fever, to clean everything I touched – that’s from my nursing background. I’m happy to say my roommates didn’t get the virus.” Family and friends sent care packages and checked in with phone calls and texts which helped buoy Katie’s spirits.

A few days after starting medication, Katie began to rapidly recover. She attributes this, in part, to being a lifelong athlete, playing in Australian and Gaelic football leagues. “When I got COVID-19, I lost about 10 pounds in a week and I lost a lot of my fitness. When my taste started to come back, I was able to eat more and work towards regaining my fitness.”

Katie is using her experience with COVID-19 to assist others. “A friend of mine who is a nurse told me about a clinical study, so I registered for it. The purpose of the study is to monitor levels of COVID-19 antibodies present to see how long they last in a recovered patient’s body. It’s a two-year commitment.”  On a monthly basis, Katie’s blood is drawn and analyzed. Currently, she has not been notified of recent results and she hopes to be informed soon.

In her role as a nurse on the COVID-19 infection control team at Boston Emergency Medical Services, Katie shares her story with EMTs and paramedics who have been exposed to or have contracted the virus while treating and transporting patients. “This is an isolating disease,” Katie explained. “Not having a stigma attached to it is important. It helps them when I explain what I went through when I was sick.”

When asked if she is concerned about contracting COVID-19 again, Katie said “I probably should be. I have reached the same fatigue that everyone in the world has now, around COVID-19. It’s hard to maintain that level of high alert. But I am being careful, more for others than for myself. I wear a mask everywhere, even when I am running outside. I do it because I don’t want anyone else to get it.”

Katie cautions others to be just as vigilant. “Just because we’re opening up, it’s not over. Wear a mask to protect yourself and others. Keep talking about it so that people don’t forget.”

CISCRP Explores the Impact of COVID-19 on Clinical Research

The recent public healthcare crisis has generated an increasing amount of attention on the topic of clinical research.  In light of this, CISCRP conducted a brief survey among the public and patients in April 2020 to assess the impact of the pandemic on clinical research perceptions and experiences. The final report can be accessed here.

Five hundred diverse individuals in the United States and a few select countries in Europe (United Kingdom, France, Germany and Italy) completed the survey. Eighteen percent of the respondents have clinical trial experience. Of those who have participated in clinical research, more than half (56%) are currently enrolled in a clinical trial for COVID-19. Where appropriate, comparisons were made to the baseline 2019 Perceptions & Insights Study, a biennial large-scale global analysis of public and patient views of and experiences with clinical research to identify any notable differences.

Overall, awareness of clinical trials remains low – as 58% had not heard of a COVID-19 clinical research study recently.

“Interestingly, among the minority that had recently heard of a COVID-19 clinical research study in the recruitment phase, we learned that a higher proportion (40%) of Europeans are aware than Americans (34%),” said Annick de Bruin, Director, Research Services. “This contrasts with our larger baseline 2019 Perceptions & Insights Study where we found that North Americans are more likely to be aware of a current clinical trial in general than any other region.  This may partially be due to the fact that the crisis evolved earlier in Europe.”

Misconceptions about the clinical research development process persist.  Most (60%) think a treatment or vaccine for the virus will be developed in less than one year. Once developed, the majority (64%) think it will be less than a year before people can start receiving it.

Patients currently enrolled in ongoing clinical trials for conditions other than COVID-19 report experiencing changes as a result of the pandemic such as telemedicine, study medication delivered to their homes, and the use of smartphone apps. Twenty-six percent report a suspension of the clinical research study in which they were enrolled and 11% report a reduced number of in-person clinic visits.

Top motivators for participating in a COVID-19 clinical research study include altruistic reasons with 46% mentioning ‘to help others who are suffering’ and 46% mentioning ‘to advance science and the treatment of COVID-19.’  These motivations are in line with findings from the larger baseline 2019 Perceptions & Insights Study.

Both the COVID-19 special report, as well as the 2019 baseline reports are available free of charge on the CISCRP website under Research Services, https://www.ciscrp.org/services/research-services/ . CISCRP also presents the aggregate results of the Perceptions and Insights Study at industry conferences, company meetings, and other virtual and in-person forums. For a detailed, in-depth report with a facilitated virtual meeting or webinar, please contact Annick de Bruin at adebruin@ciscrp.org or call 617-725-2750 x400.

 

Maintaining Clinical Trial Continuity During COVID-19: The Patient Perspective

In this May 2020 podcast, Ken Getz, Founder and Board Chair, CISCRP, moderates a panel from Parexel that explores how clinical trials have changed and adapted since the outbreak of the COVID-19 pandemic. The panel, featuring three members of Parexel’s Patient Advisory Council, along with Parexel’s Chief Medical & Scientific Officer, Dr. Sy Pretorius, discuss how changes may impact clinical trials in the future for patients. Access the podcast here.

Innovative Partnership Nominated for Citeline Award

CISCRP proudly participated in a 2019 collaboration with Biogen, the National Minority Quality Forum (NMQF), Tufts Center for the Study of Drug Development (CSDD), Langland, H.E.A.L. and the FDA’s Office of Minority Health and Health Equity to engage directly with the general public through grass-roots outreach campaigns and events; to listen to their level of understanding, awareness, and concerns through digital channels, in-person meetings and interviews; and to provide resources to support education about clinical research participation. These efforts proved valuable and impactful, receiving endorsement to continue to build and expand these efforts in 2020 and beyond. This innovative 2019 project has recently been nominated as a finalist in the 2020 Citeline Awards for Medidata Clinical Partnership of the Year.

The team worked to better understand the challenges and barriers encountered by African American and Hispanic/Latinx communities in the US regarding awareness, access to clinical research participation, and health care provider involvement in evaluating research opportunities. 

As a part of this large engagement campaign, Tufts CSDD conducted in-depth interviews among minority physicians, investigators and nurses to explore barriers and challenges to clinical trial access and referral, as well as high incidence of minority investigator drop-out rates. An online social listening campaign was launched to follow conversations and sentiments around clinical trials among African Americans and Hispanic/Latinx communities. CISCRP and the NMQF organized public-facing programs that offered free health screenings and educational sessions. The FDA participated in Biogen’s Patient Engagement Day and spoke to the importance of engaging underrepresented minorities in clinical trials.

Insights obtained from these conversations will assist the team in enhancing current structures and implementing new efforts to increase access to clinical trial sites and site participation in clinical trials. Feedback provided by online social listening and healthcare providers reinforced existing barriers to clinical research participation for members of diverse communities.

“While the public continues to acknowledge the importance of clinical research in identifying new medicines, general awareness and participation in clinical research studies remain low for a variety of reasons, and minority populations continue to be underrepresented in clinical trials,” said Ellyn Getz, Associate Director, Development and Community Engagement for CISCRP. “Many learnings from this year-long program will be applied in 2020 to patient engagement strategies, protocol entry criteria, site selection, and patient outreach.”

In 2019, approximately 2,000 people attended NMFQ’s community health events and CISCRP’s AWARE for All programs and learned about clinical trial participation. Over 500 event attendees surveyed indicated that they are somewhat or very interested and willing to participate in a clinical trial and are eager to participate if invited by their health care provider. This indicates an opportunity to further engage, educate, and connect underrepresented patients with clinical trial site teams.

This innovative collaboration has built a strong foundation for continued grass-roots outreach efforts. Biogen is supporting the AWARE for All: Clinical Research Education event series over the next five years as a member of CISCRP’s AWARE Industry Consortium. The consortium addresses the critical need to improve patient diversity in clinical trials.

For more information, please contact Joan Chambers, CISCRP’s Senior Director, Marketing and Outreach, at jchambers@ciscrp.org or Ellyn Getz, Associate Director, Development & Community Engagement, at ellyngetz@ciscrp.org.

Building A Clinical Trials Website that Engages Patients & the Public

In this webinar, a speakers from Merck/EMD Serono, TrialScope and CISCRP discuss building a clinical trials website that engages patients and the public.

Robert Janiak, Head of Clinical Trial Transparency, Merck KGaA, Darmstadt, Germany, which operates its healthcare business as EMD Serono in the US and Canada, reviews the launch of a dedicated clinical trials website using the TrialScope Engage™ platform. Jill McNair, Senior Director, Health Communication Services for CISCRP, discusses how CISCRP obtained patient input and how that feedback guided content creation. Naor Chazam, CMO, TrialScope explains how its technology — syncing clinical trial data to the website and generating robust search functionality — helps patients find and enroll in relevant trials, and keep participants informed of study updates and results.

Register here. 

 

New Consortium Launched In Partnership with CISCRP to Improve National Clinical Research Literacy

Research in the literature shows that minority communities have a high willingness to participate in clinical trials and high self-reported general knowledge about the clinical research process. Yet, according to a recent study conducted by the Center for the Study of Drug Development at the Tufts University School of Medicine, minority patients – most notably those of Black and African descent– are highly underrepresented in clinical trials of new medical interventions. Tufts research also shows that patient referral rates into clinical trials among practicing minority physicians and nurses are very low.

To address the critical need to improve patient diversity in clinical trials, CISCRP – in partnership with ten leading pharmaceutical companies and clinical research service providers – has launched a new consortium that will focus energy and resources on community-based education during the next five years beginning in early 2020. Consortium members include Merck, IQVIA, Biogen, Otsuka, CSL Behring, Janssen, WCG, Boston Scientific, EMD Serono, and Pfizer. Representatives from each member company will participate on a steering committee and will provide staff and resources to support the planning and execution of live educational events in five targeted urban centers annually.

“This centralized approach is vital to bring together the necessary oversight and infrastructure required to engage with communities from around the country,” said Jonathan Jackson, Ph.D., study volunteer and The Center Director of Community Access, Recruitment, and Engagement (CARE) Research Center at the Massachusetts General Hospital, Harvard Medical School.

The Consortium initiative builds on CISCRP’s 18-year experience producing and hosting internationally recognized live educational events – called AWARE-for-ALL programs — throughout the United States and parts of Europe. Each event engages a local planning committee comprised of members of the public, patients, advocacy groups, health care and clinical research professionals, offers educational presentations and discussions, as well as free health screenings and information about local clinical trial activity. The consortium also plans to mobilize a pop-up educational exhibit in targeted urban health centers to generate excitement and awareness in the weeks leading up to each live event.

“We are thrilled to be working with Consortium members on this important and novel initiative,” said Ellyn Getz, Associate Director of Development & Community Engagement at CISCRP. “Support, input and insight from consortium members presents an unprecedented opportunity to have an even greater impact on advancing public and patient clinical research literacy over a 5-year time period with ongoing continuous improvement,” she added.

ABOUT CISCRP:

The Center for Information and Study on Clinical Research Participation (CISCRP) is an internationally recognized 501(c)(3) non-profit organization dedicated to educating, informing and engaging the public

and patients about clinical research. CISCRP is committed to providing services designed to help professionals best engage patients as partners in the clinical research process. Visit www.CISCRP.org .

Contact Information
Joan A. Chambers
Senior Director, Marketing & Outreach
CISCRP

Phone: 617-725-2750 ext. 202

www.CISCRP.org

 

2019 Q4 USA Today Clinical Research Supplement

To read the online article, Clinical Trial Participants Are Changing Lives by CISCRP Found Ken Getz, please click HERE.

To read the online article, How a Clinical Trial Participant Became An Advocate for the Sickle Cell Community, by MediaPlanet journalist Kristen Castillo, please click HERE.

A Very Special “Thank You” to Our Sponsors:

BENEFACTOR
Janssen
Merck
Pfizer
Bristol Meyers Squibb

PATRON
Segal Trials
PMG Research
Allergan
Praxis

CISCRP would like to recognize and extend a ‘Thank You’ to Praxis for donating their pro-bono graphic design expertise to create the advertisement.

View the Advertisement.

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