A new form of health communication: Plain Language Summaries of Publications

Written by Kim Edwards | kedwards@ciscrp.org

New to CISCRP’s service offerings is the development of Plain Language Summaries of Publicationsalso called PLSPs. Using the same best practices that we apply to trial results summaries, we translate an original scientific article into easy-to-understand language and graphics. Together with Oxford PharmaGenesisa global provider ofmedical,regulatory,andscientific writing, we are excited to be involved in the creation of several PLSPs. These PLSPs may be a resource for patients and the public, patient advocacy groups, and non-specialist clinicians with little time. 

Each PLSP that CISCRP creates is reviewed by an editorial panel made up of patients, professionals, patient advocates, and members of the public. These volunteers provide valuable feedback to help us make sure that the PLSP is educational, clear, and complete. 

PLSPs can be published as standalone articles or alongside the original scientific article. They can be provided through a sponsor’s website, patient advocacy websites, direct mail campaigns, and webinars. While PLSPs are a new and developing form of health communication, CISCRP’s established skillset allows us to meet the increasing demand for PLSPs. Amedia and public attention around medical research and clinical trials continues to growthe value of PLSPs is clearNow more than ever, it is important that everyone has access to easy-to-understand scientific and medical information. 

We invite you to read this PLSP we createdIt was recently published in Future Oncology and translates results of the ARAMIS trial originally published in the New England Journal of Medicine. 

4 ways AWARE for All has adapted in 2021

Written by Ellyn Getz and Phyllis Kaplan
egetz@ciscrp.org
pkaplan@ciscrp.org

In 2020, the AWARE for All program experienced an abrupt and drastic transfer from a live-educational event model to a completely virtual engagement program. The CISCRP team shifted quickly to create accessible and meaningful virtual programs to educate the public about clinical research participation and address concerns about the COVID-19 vaccine. 

AWARE for All gathered great visibility as a fully virtual engagement program. Over 60% of our health fair visitors and webinar attendees represented public and patient communities. Walso hosted over 30 exhibitors per virtual health fair. In addition, each of the five campaigns that participated shared educational content with over 700,000 people through creative marketing and communication strategies. 

CISCRP was proud to work with the AWARE Industry Consortium, a team of ten leading pharmaceutical companies and clinical research service providers. The team also includes local advocacy and research groups to assist in leading this national outreach campaign. We are so excited to build on this momentum in 2021. 

Year 2 of the AWARE Industry Consortium will continue to focus energy and resources on community-based education. Our main focus will be to increase clinical research literacy and engage with diverse communities around the world. Consortium members include Biogen, CSL Behring, EMD Serono, Genentech, IQVIA, Janssen, Novartis, Otsuka, Pfizer, and WCG. And this year, we plan to finetune our approach to expand our reach and leverage the benefits of virtual education. 

Here are the most notable adaptions in 2021 with hopes to host in-person programs again in 2022: 

  1. Information exhibit center…in virtual reality. The team partnered with Illumina Interactive to build a virtual health fair, mimicking as close as possible the experience of an in-person exhibit hall. This virtual experience was recognized by Platinum eHealthcare Leadership award and the OMNI Awards in the Health and Fitness and Non-Profit categories. Our plan is to include one national health fair with add-on regions, share participant stories, and have health and wellness pavilion. 
  1. city-specific approach to a regional focusTaking advantage of the virtual environment, the events will be spread out over five regions across the United States, something we have never done beforeThis expanded focus should reach over 10 million people! 
  1. 2 to 3 therapeutic areas will be featured at each event. We will feature 2 to 3 therapeutic areas or medical conditions per event This will help increase engagement with those who have a special interest in these areas. 
  1. Our 2-hour webinar will be shortened to 90 minutesVirtual fatigue is something that has to now be considered, and it is no joke! We have decided to shorten the event to 90 minutes to avoid this. 

We invite you to join us as we take AWARE for All virtually on the road to these regions: 

  • AWARE  Northeast: April 15th 
  • AWARE  Northwest May 20th 
  • AWARE  Midwest July 22nd 
  • AWARE  Southwest: October 21st
  • AWARE  Southeast November 18th  

Registration details are posted on the CISCRP events website. 

If you are interested in participating as a speaker, virtual exhibitor, or outreach supporter, please email Phyllis Kaplan at pkaplan@ciscrp.org. 

2021 Perceptions and Insights Study to focus on diversity, inclusion, and the impact of the COVID-19 pandemic

Written by Shalome Sine | ssine@ciscrp.org

Planning for the 2021 Perceptions and Insights Study is underway! 

It is more important than ever to better understand the public’s views of and experiences with clinical trials. The COVID-19 pandemic and vaccine development have taken over headlines globallyturning the public’s attention to the topic of clinical research and the pharmaceutical industryThis past year also saw the United States address racial inequities that have been built into our systems. The public’s focus on clinical trials alongside diversity and inclusion issues is unique. 

So, how have these events affected the ways that patients and the public feel about the importance of diversity and inclusion, specifically in terms of clinical trial participation? 

These are some of the biggest questions facing the industry, and CISCRP’s Perceptions and Insights Study can help to answer them. The Perceptions and Insights Study is a global survey of thousands of respondents that has taken place every 2 years since 2013. The study assesses current attitudes toward clinical research and experiences participating in clinical trialsAs we prepare and plan for this year’s survey, here are 3 ways the 2021 findings can help inform your patient engagement strategy: 

  1. Trends: We’ll carry questions from previous years so that we can continue to track trends over time. This will allow you to see how the events of 2020 have impacted perceptions and experiences of clinical research compared to previous years.

  2. COVID and the rise of remote clinical trial models: We’ll ask those who participated in clinical trials whether they used technologies or alternative clinical trial models (like virtual or home nurse visits), as these were often used in 2020 to limit in-person contact and reduce the spread of COVID-19We’ll also ask how these new technologies impacted their experiences and satisfaction as a clinical trial participant.

     

  3. Diversity and inclusion in clinical trials: The 2021 survey will also include new questions on diversity and inclusion in clinical trials, offering valuable insights into the views of patients and the public on the importance of including a diverse group of participants in the clinical research process. We will also look at the motivations and experiences of underrepresented communities to identify ways to improve engagement among these groups. 

The survey will launch later this spring, with results available in September 2021. Keep an eye on the CISCRP website to be notified as soon as results are available! 

Click here to review the results of the 2019 Perceptions and Insights study and see general trends found over time so far. 

CISCRP supports Operation Warp Speed vaccine sponsors with Plain Language Communication

Written by Jill McNair | jmcnair@ciscrp.org

In December 2020, CISCRP announced that it is providing plain language communication consulting and services to companies involved in Operation Warp Speed.” As readers may know, Operation Warp Speed is a public-private partnership started by the US government to help in the development, manufacturing, and distribution of COVID-19 vaccinesCISCRP has pledged to volunteer our knowledge and resources to assist Operation Warp Speed sponsors. We are pleased to be providing our services to AstraZeneca, Janssen Pharmaceuticals, Moderna, and Pfizer. 

 

For more than 10 years, CISCRP has been translating scientific clinical trial results information into plain language for patients and the public around the world. To deliver on our pledge, CISCRP is continuing to do this by assisting Operation Warp Speed vaccine sponsors in a variety of ways. This includes: 

  • developing, producing, and distributing plainlanguage trial results summaries 
  • translating scientific medical journal articles into plain language 
  • preparing plain language content to be communicated in print and digital formats  

 

Oxford PharmaGenesis, a global provider of medical, regulatory, and scientific writing, will also be volunteering its services together with CISCRP to support Operation Warp Speed sponsors. 

The demand from the public, patients, and the healthcare community for plain language information about the results of COVID-19 vaccine trials is high. Health officials and Operation Warp Speed sponsors also believe that providing clear information and results is necessary to gaining public trust and support for other vaccination programs in the future. 

Said Ken Getz, CISCRP’s founder and board chair“Given the incredible time and resource pressures that Operation Warp Speed vaccine sponsors are facing, CISCRP decided to donate staff time and expertise, its editorial panel of patients, and print production and distribution costs. We’re very pleased to be collaborating with so many COVID-19 vaccine sponsors. And in the process, CISCRP can ensure consistenthigh quality, and compliant practices across sponsor companies. 

 

From the Editor

Dear Readers, 

As we share with you our first newsletter of 2021, we must acknowledge the harsh challenges that defined 2020. The COVID-19 pandemic has changed our way of life. It has disrupted the routines that we took for grantedand for some of us, it has brought deep and lasting loss. It has also highlighted the harsh racial inequalities that continue to existWe find as a society that there is healing needed on many levels. As we welcome the hope that comes from several promising vaccines, we are also reminded of the importance of clinical research. Further, we are reminded of the importance of clinical research education, and of ensuring equal access to information and to treatment across all communities. 

Like so many of our readers, the CISCRP staff has become used to a new way of working, of interacting. With our Boston office closed during the pandemic, we have explored different ways of communicating with each other, and importantly, of furthering our mission. We remain dedicated to helping people better understand clinical research and make informed decisions. As vaccines have taken center-stage in the mediawe have recognized a need for more information about vaccine development and drug development in general.  

We are pleased to share some of the ways in which we have begun to address this need: 

  • Together with several leading pharmaceutical companies, developed a series of animated educational videos and clips about clinical research, including vaccine development 
  • Supported “Operation Warp Speed” sponsors by volunteering our plain language expertise in the development of trial results summaries, medical journal articles, and other media 
  • Launched diversity and inclusion projects across our company to make sure that we engage under-served communities, listen to their voices, and develop our educational materials with their input 
  • Changed our AWARE for All program to a fully virtual model, including targeted educational content to address concerns about COVID-19 vaccines 

We continue to expand our service offerings and educational content to shine a light on the realities of clinical research. Especially during the pandemic, clear communication about clinical trials is critical. In this issue of our newsletter, we share a conversation with Medical Hero Jackie Zimmerman. Jackie knows well the roles of patient, trial participant, and patient advocate. Here, she shares how communicating with others about her MS diagnosis led her to become a patient advocate. 

In celebration of Medical Heroes like Jackie, CISCRP has kicked off this year’s Appreci-a-thon. We invited people to join this virtual fitness challenge starting March 1st of this year. The event runs through March 31st, so it is not too late to sign up!  

Coming up this Springwe will be offering 2 virtual AWARE for All events: a Northeast program on April 15, 2021, and a Northwest program on May 20, 2021.  

It is free to sign up for the Appreci-a-thon and the AWARE for All events. We hope you will join us as we continue to honor Medical Heroes and participate in important discussions about clinical research. Please visit our Events page at http://www.ciscrp.org/ for more information on these and other upcoming events. 

 

Thank you for your continued support as we build upon our existing resources and explore new ways to carry out our mission.  We look forward to connecting with you again in our Summer edition. 

Warm Regards, 

Brandis Pickard

Postpartum Depression (PPD) & Clinical Trials Part 2

Part 2 of a 2-part series. Medical professionals and patient advocates discuss their experiences with postpartum depression, one of the most common medical complications during and after pregnancy.

Webinar recording coming soon.

Medical Hero Spotlight: Shanelle Gabriel, Lupus Advocate

When Gabriel was in college, she always felt tired and would wake up feeling stiff. She dismissed it as general soreness from working out with her dance team.

The Brooklyn-native Gabriel, then 21, went to her doctor, who told her she probably had sinus problems and encouraged her to take allergy medicine.

Diagnosis

A turning point came a month later when she noticed patches of hair missing. She went to a different doctor who asked her a series of questions, including about how tired she was and whether her hands changed colors when they got cold. After testing, Gabriel was diagnosed with lupus, an autoimmune disease.

At the time, there weren’t medications specifically designed to treat lupus. Instead, doctors had a blanket approach and prescribed a variety of medicines, including steroids, to treat symptoms, but nothing was specific to the illness.

“Nobody knew how much pain I was in,” said Gabriel, now 36, who describes lupus as, “a hidden disease.”

Many of the medicines had side effects, including increased risk for liver and kidney problems, as well as cataracts and glaucoma.

She still had flare ups that sent her to the hospital, including an inflammation of the membrane around her heart. It was so bad, she had to leave an internship and quit the dance team.

After graduating, Gabriel toured the country as a poet and singer. While in Montana for a performance, she suffered an episode that caused her to be hospitalized due to a lupus-related condition that causes blood clots.”

Clinical trials

When her doctor suggested trying a clinical trial for a new lupus treatment, Gabriel, who’s African American, balked. She was worried because, historically, people of color have been taken advantage of during medical trials.

She later found out the trial was a success and her doctor prescribed the approved drug. The treatment worked but it was demanding, as Gabriel needed to take a full day off from work to receive IV therapy.

Next, Gabriel decided to participate in the next clinical trial, which tested that approved medicine as a self-administered, weekly therapy.

For Gabriel, this drug helped make her symptoms more manageable allowing her to discontinue her use of steroids.

Stigma

While Gabriel was initially nervous about clinical trials, she’s glad she talked with her doctor and other medical professionals, and realized that clinical trials are essential for finding new therapies and cures.

“Due to a lack of participation by women of color in a lot of these trials, (researchers) were not able to actually track if it worked for us,” she said. “There’s only one way to find out if it works; somebody has to do it.

“I just felt like, ‘You know what? I’m fine with that, because there could be a really great benefit from it.’ And I did end up benefiting from it.”

Gabriel is on the patient advisory boards for The Center for Information and Study on Clinical Research Participation, a non-profit dedicated to educating and engaging the public and patients about clinical research.

She encourages patients with lupus and other diseases to consider clinical trials, which have many safeguards to minimize danger for participants. She recommends doing your own research, asking questions, and talking to your doctor about clinical trials.

She’s sharing her story and hopes to inspire others.

“It’s becoming a community of people that are advocating and I think there is hope for a cure,” Gabriel said.

Featured in the June 2020 Clinical Trials Supplement, USA Today.

What is Informed Consent? eConsent?

Video provides a clear overview on Informed Consent and eConsent

  • Process of learning and agreeing to be in a clinical trial
  • Who to speak with and ask questions before participation
  • After giving consent, the choice to stop participating at any time for any reason
  • Understand the purpose, length, risks, benefits and what will happen during the clinical trial

Made possible by a sponsorship from Otsuka.

Plain Language Summary Publication of Key Results from Bayer’s Phase 3 ARAMIS Trial Published in Future Oncology

Boston, MA | February 16, 2021—The Center for Information and Study on Clinical Research Participation (CISCRP) and Oxford PharmaGenesis worked together with Bayer, an ARAMIS trial investigator and oncologist, an ARAMIS trial participant, and a prostate cancer patient advocate—Dr. Fizazi, Mr. Blue and Mr. Nowak, respectively—to write a plain language summary publication (PLSP) of the 2020 New England Journal of Medicine article on the ARAMIS trial.  The PLSP was recently published in Future Oncology on February 8, 2021 with the title ‘Darolutamide and survival in nonmetastatic, castration-resistant prostate cancer: A patient perspective of the ARAMIS trial’.    

Public, patient, and health care community demand for plain language information about the results of clinical trials is extremely high. For more than ten years, CISCRP — a non-profit organization — has been translating scientific clinical trial results information into plain, non-technical language for patients and the public around the world to be communicated in print and digital formats. 

The teams involved—Bayer, CISCRP, Oxford PharmaGenesis, Dr. Fizazi, Mr. Blue and Mr. Nowak—worked to ensure the PLSP was easy-to-read by adding creative visuals, tables and key questions answered about the ARAMIS trial.  The inclusion of patients’ perspectives in PLS publications are important as it conveys unique insights and perspectives that highlight the importance of patient participation in ongoing clinical trials and empower patients to engage in treatment discussions.  In addition, this PLSP was reviewed by an editorial panel inclusive of patients, patient advocates, public and healthcare professionals to evaluate and confirm that a ‘patient-first’ approach was taken in the writing, design, and layout to help patients and caregivers understand the trial results.

The PLSP highlights the ARAMIS clinical trial that began in September 2014 and ended in September 2018 with 1,509 male participants in ages ranging from 48-95. The demographics included 1,194 Caucasian participants, 52 African Americans or Blacks participants, and 193 Asians participants from 36 countries.

The clinical trial was conducted in adult participants with non-metastatic, castration-resistant prostate cancer (nmCRPC) who received a treatment called darolutamide (brand name Nubeqa®) plus androgen deprivation therapy (ADT) . Darolutamide is approved in several markets around the world, including the U.S., the European Union (EU), Brazil, Canada, Japan and China, as an oral treatment for adults with nmCRPC who are at high risk of developing metastases.  The product is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

“New therapies to treat prostate cancer in men are being developed rapidly,” wrote Mr. Blue, a patient author.  “After five years in the ARAMIS trial, I have been very pleased to see the positive outcomes of the trial which has given me hope for a continued good quality of life for the foreseeable future.”

“Clinical trials are life.  Very simply, for us patients, clinical trials are our life force,” wrote Mr. Nowak, a patient author. “Clinical trials have become so advanced. Today we evaluate if a new potential treatment extends our life. We are often asking if this new treatment will also improve the quality of our life. For me, improving the quality of my life is just as important as extending it.”

Read the full PLSP in Future Oncology here, https://www.futuremedicine.com/doi/10.2217/fon-2020-1291

About the Center for Information and Study on Clinical Research Participation (CISCRP)

CISCRP is a Boston-based, globally focused, non-profit 501(c)(3) organization providing public and patient education and advocacy.  CISCRP’s mission is to inform patients and the public about clinical research and the important role that it plays in advancing public health and to help stakeholders in drug development engage with patients and the public as clinical research partners. www.CISCRP.org

About Oxford PharmaGenesis

Oxford PharmaGenesis is an award-winning, independent, global HealthScience consultantcy—providing communications services to the healthcare industry, professional societies and patient groups.  Our clients choose us because we provide the highest level of quality, the deepest level of therapy area experience and the most compelling approaches to evidence communication.  www.pharmagenesis.com

About Bayer  

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.com.

PR Contact:                     Joan Chambers, Senior Director, Marketing
                                             jchambers@ciscrp.org
                                             617-725-2750 (Ext. 202)

Autumn 2020

Autumn 2020 Campaign

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Thank You to Praxis

CISCRP would like to recognize and extend a ‘Thank You’ to Praxis for donating their pro-bono graphic design services to create the full page advertisement. View the advertisement here by clicking on the star.

 

To participate in this or another upcoming media campaign to continue to build education and awareness about clinical research, please contact Matt Steele at msteele@ciscrp.org.