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.

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)

CISCRP Provides Plain Language Clinical Trial Communication Services to Support Operation Warp Speed Vaccine Sponsors

Boston, MA | January 14, 2021—The Center for Information and Study on Clinical Research Participation (CISCRP) today announced that it is providing plain language communication consulting and services to companies involved in Operation Warp Speed vaccine studies.  Late last year, CISCRP pledged to donate its expertise and production capabilities to assist Operation Warp Speed sponsors.  At that time, companies soon-to-receive emergency use authorizations and those in late-stage clinical trials began collaborating with CISCRP.

 

Public, patient, and health care community demand for plain language information about the results of COVID-19 vaccine clinical trials is extremely high.  At the same time, health officials and Operation Warp Speed vaccine sponsors believe that transparency and disclosure of clinical trials results and information is essential to engendering public trust and facilitating broad support for vaccination programs that are now rolling out globally.

 

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 deliver on its pledge, CISCRP is assisting Operation Warp Speed vaccine sponsors in a variety of ways including sharing best practices; developing, producing, and distributing plain language trial results summaries; and 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 donating its services in collaboration with CISCRP on this important initiative. 

 

“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,” said Ken Getz, CISCRP’s founder and board chair.  “We’re very pleased to be collaborating with so many COVID-19 vaccine sponsors.  And in the process, CISCRP is able to ensure consistent, high quality and compliant practices across sponsor companies,” he added.

 

For more information about CISCRP’s pledge to support Operation Warp Speed vaccine studies, contact Jill McNair, Senior Director, Health Communication, CISCRP via email jmcnair@ciscrp.org or phone at 617-725-2750 (Ext 101).

 

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)

 

Contact:                 Joan Chambers
                                 Senior Director, Marketing
                                 jchambers@ciscrp.org
                                 617 725 2750 ext. 202

Parents & Children Share Perceptions & Experiences with Clinical Research: Survey

During the month of April 2020, CISCRP conducted an online US-based survey among 500 parents and their children. The goal of this survey was to gain insight into general perceptions of pediatric trials, preferred channels of communication, key information parents and their children would want about pediatric clinical trials, as well as past or current experiences participating in pediatric clinical trials.

The findings of this Pediatric Perceptions and Insights Study illustrate what matters most to patients and their parents and offer ways to best support and inform prospective pediatric volunteers and their guardians before, during, and after the clinical research process. You can review the report here.

Understanding and Awareness of Clinical Research High among Parents, but Children were Unsure

Parents generally self-report high levels of understanding about clinical research, and generally high willingness to have their child participate in a clinical research study. Awareness, understanding, and willingness to have their child participate were greatest among parents whose children have previously participated in clinical research.

Among children, levels of awareness of clinical research vary by child’s age, as older children were more likely to have heard of clinical research compared to younger children. Overall, few report that they understand clinical research “Very Well.” Though many were not sure whether they would want to participate, 50% report that they would be willing. The top motivation to participate was altruistic as children wanted to advance science through their participation.

Parents and Children Alike Report Burdensome Participation Experiences Despite Good Communication with the Study Team

During participation, parents report highly burdensome experiences and high levels of disruption to their daily routine. Top burdens included traveling to the study clinic and having their child complete lab work (like blood draws and urine tests). However, the majority of parents said that they received updates or study results once their child finished participation.

Results also indicate that children generally received adequate information about their participation. 92% remembered getting information about the clinical trial before they joined, and 85% found this information ‘Kind of’ or ‘Very Easy’ to understand. Despite these expectation-setting measures, children reported some study requirements as difficult to complete, most notably taking the study medication and undergoing blood draws. However, though children report burdensome study experiences, most indicate that the study exceeded their expectations and they would be willing to participate again.

HCPs Key for Parents to Decide to Have Their Child Participate

A consistent theme throughout the survey findings was the critically important role that healthcare professionals play at several points along the journey toward participation. For example, parents discuss clinical research with their child’s doctors often and cite their child’s doctors as the top way they learn about participation opportunities. Children would also most prefer to learn about clinical research through their doctor. Doctor’s recommendations were ultimately the top reason that parents decide to have their child participate.

You can view other CISCRP reports on clinical research perceptions and experiences here.

 

 

2020 Pediatric Perceptions & Insights Study Yields Important Insights on How to Enhance Pediatric Clinical Trial Participation

Survey Conducted by CISCRP and Commissioned by Parexel Shows Perceptions of Clinical Research Are Positive but Logistical Burdens Limit Children's Participation

BOSTON, MA, Dec. 8, 2020 – A 2020 survey of 500 parents and children in the U.S. conducted by the Center for Information and Study on Clinical Research Participation (CISCRP) and commissioned by Parexel has yielded critical insights into why families choose to participate in clinical research and how to design clinical trials to better fit their needs, according to the survey report.

Pediatric participation in clinical trials is essential to understanding how drugs perform in children, whose physiologic responses to medications and unique disease variants are often different from adults.

While survey respondents expressed largely positive views of pediatric clinical research, actual participation in pediatric research remains low. Only 16.7 percent of clinical trials registered on the World Health Organization’s (WHO) portal involve pediatric patients, and only 12% of trials registered on clinicaltrials.gov are pediatric trials, even though children contributed to almost 60 percent of the total disease burden of the conditions being studied.1  As a result of low pediatric participation, the majority of drugs prescribed to children are only evaluated in adults.2

“Understanding patient health journeys and study volunteer experiences is critical to designing more patient-friendly trials that ultimately enhance pediatric patient participation, so that we can continue to develop newer, safer and more effective drugs for children,” said Ken Getz, Founder and Chairman at CISCRP.

Among the key findings from the survey:

  • Determinants: Parents cited their pediatrician’s recommendation as the most important factor when deciding to enroll their child in a trial, and they ranked the potential risks and benefits of the study drug as the most important information they needed to make a decision
  • Motivations: Children cited the desire to help scientists and doctors learn more about their disease as a primary motivation for participating
  • Barriers: 52 percent of children indicated it was very important to have some or all of their study visits at home if they were part of a research study
  • Diversity: Parents who identified as Black self-reported a better understanding of clinical research and were more willing to enroll their child in a clinical trial than parents who identified as Caucasian
  • Perceptions: The majority of children reported a positive experience with clinical trials, and 90 percent indicated that they would join another study

“The results from this survey inform tangible steps we can take as an industry to encourage more pediatric participation in clinical trials, including more decentralized clinical trial approaches, enhanced communication with caregivers about clinical trials as a care option and better engagement between industry and pediatric providers,” said Sy Pretorius, MD, Executive Vice President and Chief Medical & Scientific Officer at Parexel. “The pandemic has further demonstrated the benefits of bringing trials to patients in their homes, rather than asking patients to come into the clinic for every visit, and this is amplified in the context of pediatric trials.”

Pediatric participation in clinical trials is an issue of growing importance as the medical community has embraced the need to better understand the effects of medications in children. In 2012, Congress passed the Food and Drug Administration Safety and Innovation Act to incorporate pediatric evaluations earlier in the drug development process, legislation which has resulted in 500 pediatric-specific drug-labeling changes. 2

The Pediatric Perceptions & Insights Study was created, in part, as an outgrowth of questions included in the baseline CISCRP Perceptions & Insights Study that is conducted biennially in adult populations, which gauges public and patient perceptions, motivations, and experiences regarding clinical research participation. Its goal is to monitor trends and identify opportunities to better inform and engage the public and patients as stakeholders and partners in contributing to the clinical research enterprise.

To view the Pediatric Perceptions & Insights Study final report, please click here.

To hear a podcast about the survey results featuring a parent advocate survey respondent, please visit click here

About Parexel
Parexel is focused on supporting the development of innovative new therapies to improve patient health. We do this through a suite of services that help life science and biopharmaceutical customers across the globe transform scientific discoveries into new treatments for patients. From clinical trials to regulatory and consulting services to commercial and market access, our therapeutic, technical and functional ability is underpinned by a deep conviction in what we do. For more information, visit https://www.parexel.com/.

 

About CISCRP
CISCRP (Center for Information and Study on Clinical Research Participation) is an internationally recognized non-profit organization dedicated to educating and informing the public and patients about clinical research. Located in Boston, Massachusetts, CISCRP works to raise awareness, enhance experiences, and strengthen communication and relationships among participants, research professionals and the public through various services and events. For more information, visit https://www.ciscrp.org/.

References: 1https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4345947/#:~:text=Despite%20about%2027%25%20of%20the,Organization%20(WHO)%20portal%2034

2 https://pediatrics.aappublications.org/content/144/4/e20191571

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Clinical Research Process Demystified on December 8th with Interactive Webinar

Local Partners, Nonprofit Advocates & International Organizations Share Information about Clinical Trials

Miami, FL, December 2, 2020CISCRP (Center for Information and Study on Clinical Research Participation), a non-profit, invites members of the Miami community to attend AWARE for All – Miami, a free, interactive webinar that:

  • demystifies clinical trials
  • reveals what the experience is like for participants
  • reviews the role and responsibilities of involved medical professionals
  • reinforces the critical role that individuals who participate in clinical trials play in advancing new medicines and treatments

The webinar is scheduled for Tuesday, December 8th, from 4-6pm EDT via a customized, secure online platform.

“The idea of participating in clinical trials is an unfamiliar one, for the vast majority of individuals,” said Joan Chambers, Senior Director CISCRP. “Most people first learn about them at the same time they’ve been diagnosed with a serious illness for which no medication is adequate, or available. There’s a rush for patients and their loved ones to navigate this unfamiliar terrain, in order to make the decision to participate – or not. They have to discuss options with their health care providers. Our AWARE for All programs provide vital information and insight, with a local focus, that can help.”

During the free webinar, attendees learn about clinical trials straight from the patients and researchers who take part in them with a facilitated conversation and will be able to submit questions via a chatbox during the program. Dr. Rishi Kakar, Chief Scientific Officer & Associate Medical Director, Segal Trials, will be the overview speaker. There will be two 5-minute health assessments, including a breast cancer assessment offered by the Florida Breast Cancer Foundation and a mental health/depression exercise offered by Segal Trials.

A virtual health fair with over 30 local and national health and wellness organizations providing educational resources is also part of the platform.

CISCRP’s AWARE for All – Miami program comes at a critically important time. Public interest in learning about clinical trials is high and the need for study volunteers in all disease conditions—including COVID-19 clinical trials—has increased significantly. Led by CISCRP and supported by local research organizations, advocacy groups and a consortium of biopharmaceutical and service provider companies, the educational program is open to all members of the public.

Paulette McDaniels shared that she participates in clinical trials because as an African American woman, she thinks it is important to bring parity to health care. She has participated in studies that focus on osteoporosis, asthma and breast cancer research. “I want to contribute to making health care better for all African Americans,” she said.

“At CISCRP, helping patients and the public learn about the importance of clinical research participation is at the heart of our mission. We’re extremely excited to be presenting this event with support from a diverse team of stakeholders from the Miami community,” said Joan Chambers.

The AWARE for All – Miami supporters include Allergy & Asthma Network, American Kidney Foundation, Arianna’s Center, k, Clinical Pharmacology of Miami, Clinical Site Partners, LLC, Debbie’s Dream, Florida Breast Cancer Foundation, JDRF, , Lupus Research Alliance, Myovant, NAMI, National Kidney Foundation, National MS Society, Pals for Health, Peoples Science, Segal Trials, Susan G. Komen,  and the AWARE Industry Consortium.

AWARE for All – Miami Clinical Research Webinar will be held Tuesday, December 8th, from 4-6pm EDT.  Attendance is free, but please register today by clicking here. To learn more, visit awareforall.org or call 877-633-4376.

About CISCRP

The Center for Information and Study on Clinical Research Participation (CISCRP) is a 501(c)(3) non-profit organization dedicated to engaging the public and patients as partners in the clinical research process. CISCRP provides free education and outreach to the general public and patient communities. Visit www.CISCRP.org for more information or to participate in CISCRP’s educational initiatives. For additional questions about AWARE for All, contact awareforall@ciscrp.org or call 877-633-4376.

Clinical Research Process is Explained in Miami-focused Webinar December 8th

Local Partners, Nonprofit Advocates & International Organizations Share Information on Clinical Research

Miami, FL, November 23, 2020— The AWARE for All – Miami webinar is an important program that builds awareness about both clinical research participation and the critical role that individuals who participate in clinical trials play in advancing new medicines and treatments.

The Center for Information and Study on Clinical Research Participation (CISCRP) invites the Miami community to attend AWARE for All, a free webinar about clinical trials on Tuesday, December 8th, from 4-6pm EDT via a customized, secure online platform.

For the vast majority of individuals, the idea of clinical trials is a new and unfamiliar one. Most people first learn about clinical trials at the same time they are diagnosed with a serious illness for which no medication is available or adequate. Patients, their families, friends and health care providers must gather information quickly to make decisions about whether to participate. This rush to navigate the unfamiliar terrain of clinical trials is often overwhelming and confusing.

CISCRP’s AWARE for All – Miami program comes at a critically important time. Public interest in learning about clinical trials is high and the need for study volunteers in all disease conditions—including COVID-19 clinical trials—has increased significantly. The free program aims to offer an introduction and insight into the clinical research process, the decision to participate, and even the research team and their roles. Led by CISCRP, a non-profit, and supported by local research organizations, advocacy groups and a consortium of biopharmaceutical and service provider companies, the educational program is open to all members of the public.

Clinical research participant Jim Butler thanks his wife who brought the clinical trial opportunity to his attention and feels it was “an important way to be proactive about his diagnosis.” Jim referred to his research participation as something that he “feels really good about doing and is glad he can contribute to…”

Tomma Hargraves is a clinical trial participant and credits her participation with surviving Stage 3 lung cancer 14 years ago. Since then, she has participated in other clinical trials and serves as a patient liaison helping others navigate clinical trials.

Dr. Rishi Kakar, Chief Scientific Officer & Associate Medical Director, Segal Trials will be the overview speaker. In addition to a facilitated conversation with patients, researchers and health care professionals, there will also be two – 5-minute health exercises and a virtual health fair with over 30 local and national community health organizations.

“This unique online program will answer a lot of key questions about the clinical research process, how clinical trials work, and what to expect as a study participant´ said Joan Chambers, Senior Director at CISCRP.  “Viewers will learn about clinical trials, straight from the patients and researchers who take part in them with a facilitated conversation and be able to submit questions via a chatbox during the program. We’re extremely excited to be presenting this event with support from a diverse team of stakeholders from the Miami community.”

AWARE for All – Miami Clinical Research Webinar will be held Tuesday, December 8th, from 4-6pm EDT.  Attendance is free, but please register today by clicking here. To learn more, visit awareforall.org or call 877-633-4376.

The AWARE for All – Miami supporters include Allergy & Asthma Network, American Kidney Foundation, Arianna’s Center, Bladder Cancer Advocacy Network, Clinical Pharmacology of Miami, Clinical Site Partners, LLC, Debbie’s Dream, Florida Breast Cancer Foundation, JDRF, Latino’s Salud, Lupus Research Alliance, Myovant, NAMI, National Kidney Foundation, National MS Society, Pals for Health, Peoples Science, Segal Trials, Susan G. Komen,  and the AWARE Industry Consortium.

About CISCRP

The Center for Information and Study on Clinical Research Participation (CISCRP) is a 501(c)(3) non-profit organization dedicated to engaging the public and patients as partners in the clinical research process. CISCRP provides free education and outreach to the general public and patient communities. Visit www.CISCRP.org for more information or to participate in CISCRP’s educational initiatives. For additional questions about AWARE for All, contact awareforall@ciscrp.org or call 877-633-4376.

 

 

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CISCRP Webinar About Clinical Trials Set for November 18th Featuring the Los Angeles Community

CISCRP (Center for Information and Study on Clinical Research Participation), a non-profit, announces it's AWARE for All webinar about clinical trials and clinical research participation. This free event has a Los Angeles focus, with patients and researchers from the area participating in a moderated panel. There is also a virtual health fair.

Los Angeles, CA — November 5th — CISCRP (Center for Information and Study on Clinical Research Participation) invites the Los Angeles Community to attend AWARE for All, a free webinar about clinical trials on Wednesday, November 18th, from 4-6PM PDT, via a customized, secure online platform.

CISCRP’s AWARE for All – Los Angeles program comes at a critically important time. Public interest in learning about clinical trials is high and the need for study volunteers in all disease conditions—including COVID-19 clinical trials—has increased significantly. The free program aims to inform and empower the public in understanding the clinical research process in order to make decisions about their health care. Led by CISCRP, a non-profit, and supported by local research organizations, advocacy groups and a consortium of biopharmaceutical and service provider companies, the educational program is open to all members of the public.

“We’re excited to be presenting this event,” said Joan Chambers, Senior Director at CISCRP. “The online program will answer a lot of key questions about the clinical research process, how clinical trials work, and what to expect as a study participant. Viewers will learn about clinical trials, straight from the patients and researchers who take part in them with a facilitated conversation and be able to submit questions via a chatbox during the program.”

Dr. Jonathan Jackson from Massachusetts General Hospital and the Harvard Medical School will be the overview speaker. In addition to the panel discussion, there will also be two – 5-minute health exercises and a virtual health fair with local and national community health advocates and researchers..

“Clinical research awareness is vital to the success of clinical trials,” added Dr. Jonathan Jackson, Ph.D., Director of Community Access, Recruitment, and Engagement (CARE) Research Center. “The success of clinical trials also depends on including a diverse and inclusive group of individuals representative of those who may receive the new therapy if it is approved for use.”

Paulette McDaniels is a clinical research participant and encourages others to learn as much as they can about a clinical trial before they decide to join. She also says you learn more about your own health and body in a clinical study, and that can help inform the study team. “It’s a team effort. If you aren’t working with your doctors and the team that’s doing the study, nobody is going to get anywhere,” says McDaniels.

Clinical research participant Jim Butler thanks his wife who brought the clinical trial opportunity to his attention and feels it was “an important way to be proactive about his diagnosis.” Jim referred to his research participation as something that he “feels really good about doing and is glad he can contribute to…”

AWARE for All – Los Angeles Clinical Research Webinar will be held Wednesday, November 18th, from 4-6pm PDT. Attendance is free, but please register today by clicking here. To learn more, visit awareforall.org or call 877-633-4376.

The AWARE for All – Los Angeles supporters include Allergy & Asthma Network, City of Hope, Pancreatic Cancer Action Network, PALS for Health, Alzheimer’s LA, Debbie’s Dream Foundation, Alliance for a Better Community, Being Alive LA, WeSPARK Cancer Support Center, Providence Clinical Research, Peer Plus, and the AWARE Industry Consortium.

About CISCRP
The Center for Information and Study on Clinical Research Participation (CISCRP) is a 501(c)(3) non-profit organization dedicated to engaging the public and patients as partners in the clinical research process. CISCRP provides free education and outreach to the general public and patient communities. Visit http://www.CISCRP.org for more information or to participate in CISCRP’s educational initiatives. For additional questions about AWARE for All, contact awareforall@ciscrp.org or call 877-633-4376.

Clinical Trials Explained, Research Participants Honored

AWARE for All Event Shares How COVID-19 Pandemic is Affecting Clinical Research

RALEIGH, N.C. (OCTOBER 5, 2020) — The Center for Information and Study on Clinical Research Participation (CISCRP) hosted its AWARE for All – Raleigh virtual community event on October 22. Hundreds of individuals attended to ask questions and to learn about the clinical research process and the role it plays in developing new treatments, vaccines, and devices. This free online event brought clinical research education directly to patients and the public and featured North Carolina-based study participants, research professionals, advocates, and industry stakeholders.

The AWARE for All – Raleigh event featured an overview presentation followed by a facilitated lively conversation with patients and health professionals, virtual health exercises—a Shibashi movement exercise and a lung cancer risk assessment; and a virtual health fair with exhibits from local Raleigh-area health and wellness organizations. The event was organized by the Center for Information and Study on Clinical Research Participation (CISCRP), a leading non-profit dedicated to educating the general public and patient communities about clinical participation. It was the organization’s third virtual event since the start of the global health pandemic in March.

Stefanie Belanger, Assistant Director of Clinical Research Operations at the Clinical Protocol Office of the UNC Lineberger Comprehensive Cancer Center presented an overview of clinical research. Clinical trials are carefully designed research studies in human volunteers to answer specific health questions. They are the fastest and safest way to find treatments that work in people and ways to improve public health.  Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.

The event featured a facilitated conversation with study volunteer Tomma Hargraves; Pablo Graiver, Vice President of Patient Engagement, IQVIA; Dr. Brian Rothman, Associate Director at Otsuka Pharmaceutical Companies; Mary Hart, Director of Research, Allergy & Asthma Network; and Dr. Purvi Parikh, Medical Director of Allergy & Asthma Associates of Murray Hill. CISCRP Founder and Board Chair Ken Getz moderated the discussion. Attendees asked a variety of questions to the patients and health care professionals to answer, making the discussion more interactive, lively and informative.

Hargraves credits her participation in a clinical trial with surviving Stage 3 lung cancer 14 years ago. Since then, she has participated in other clinical trials and serves as a patient liaison helping others navigate clinical trials.

The COVID-19 pandemic has impacted clinical trials positively in general, the panel agreed. They are generally continuing under new safety protocols to minimize contact and maintain patient and physician safety including in-home, virtual visits and telemedicine appointments.

“Remote visits, online diaries and medication delivery make it easier for patients to stay safe and continue to participate,” said Parikh. “It has become more convenient for people from rural communities to participate.”

Rothman said increased patient participation and access to clinical trials is critical. “We need data that is representative of the entire population,” he said. “The success of clinical trials also depends on including a diverse and inclusive group of people representative of those who may receive the new therapy if it is approved for use.”

As part of this online educational clinical research program, attendees had the opportunity to visit over 20 local health and wellness organizations in the virtual health fair and access educational materials and read Medical Hero articles – https://www.ciscrp.org/events/aware-raleigh-virtual-health-fair/  Organizations include Duke Health, Hemophilia of NC, Parkinson’s Association of the Carolinas, LGBT Center of Raleigh, Ronald McDonald House of Chapel Hill, and many more. The Raleigh virtual health fair remains open.

CISCRP is a non-profit organization dedicated to educating the general population and patient communities about clinical participation. They work with local advocates around the country to plan and host educational events about the clinical research process. Contact CISCRP at 1-877-MED-HERO or www.ciscrp.org to learn more about CISCRP’s mission, ‘education before participation.’

CISCRP recently launched informational videos about the different phases of clinical research participation and highlights why it takes so long to develop new therapies. The first video of the series can be viewed here: https://www.youtube.com/watch?v=iid3BMqopMM.  Additional clinical research videos are also available to watch.

The AWARE for All – Raleigh supporters include Allergy & Asthma Network, Brain Injury Association of North Carolina, Debbie’s Dream Foundation, Duke – Office of Clinical Research, Hemophilia of North Carolina, Javara, LGBT Center of Raleigh, Lung Cancer Initiative, Lupus Research Alliance, Parkinson Association of the Carolinas, PRA Health Sciences – Rare Disease Center, Ronald McDonald House of Chapel Hill and the AWARE Industry Consortium.

About CISCRP

The Center for Information and Study on Clinical Research Participation (CISCRP) is a 501(c)(3) non-profit organization dedicated to engaging the public and patients as partners in the clinical

research process. Visit www.CISCRP.org for more information or to participate in CISCRP’s educational initiatives. For additional questions about AWARE for All, contact awareforall@ciscrp.org or call 877-633-4376.

“Medical Heroes,” Participants in Clinical Trials Honored

AWARE for All Event Shares How Clinical Research Plays into Advancing Public Health

The Center for Information and Study on Clinical Research Participation (CISCRP) hosted its AWARE for All – Philadelphia virtual community event on October 1st. Three-hundred individuals attended to learn more about the clinical research process and the role it plays in developing new treatments and vaccines.  This free event brought clinical research education directly to patients and the public and featured Philadelphia-based study participants, research professionals, advocates, and industry stakeholders.

The AWARE for All online event featured a keynote and overview presentation followed by a panel discussion; virtual health exercises—a Tai Chi guided demonstration and Mindful Meditation; and a virtual health fair with exhibits from local Philadelphia-area health and wellness organizations.

Keynote speaker, Dr. Edith Mitchell, Clinical Professor of Medicine and Medical Oncology; Director of the Center to Eliminate Cancer Disparities; and Associate Director of Diversity Affairs at Sidney Kimmel Cancer Center in Philadelphia described how as a young girl growing up in rural eastern Tennessee she saw her family develop a schedule to personally care for her ill great grandfather because they believed he was more likely to survive under their care than at the local hospital as a Black man. That experience triggered her desire to become a physician and battle medical inequalities.

“Thanks to clinical research volunteers, we are all living longer, healthier lives, but we still need to increase the diversity of those who participate in clinical research,” said Dr. Jonathan Jackson, Ph.D., Director of the Community Access, Recruitment, and Engagement (CARE) Research Center.  “The success of clinical trials also depends on including a diverse and inclusive group of people representative of those who may receive the new therapy if it is approved for use.”

Jackson described the need for increased minority participation in COVID-19 clinical trials in part because the virus has disproportionally impacted minority communities. He also explained that some COVID-19 trials are moving faster than research on other diseases because research done on similar viruses is informing the COVID-19 research.

The COVID-19 pandemic has impacted clinical trials in a variety of ways, but they are generally continuing under new safety protocols to minimize contact and maintain patient and physician safety including in-home, virtual visits and telemedicine appointments.

The panel discussion was led by Ken Getz, founder and board chair of CISCRP.  Study participants and researchers focused on clinical research experiences and misconceptions, health advocacy and equity, and how the pandemic has impacted clinical trials.

During the panel discussion, study volunteers Mary Reppart and Ashley Kulp shared challenges when participating in a clinical trial, but they stated that it has always been worthwhile for them participate. They encouraged prospective study volunteers to be aware of potentially long sessions or treatments and they suggested ways to manage stress and transportation to the clinical trial site. Kulp said receiving her medication mail order and going to a local lab for blood tests has been a huge relief during the pandemic.

Jamie Houde, Senior Manager of Clinical Strategy and Innovation at EMD Serono, a panel member, described how her organization has redesigned its studies to better reflect patient diversity. She said research is a partnership between researchers and patients, and patients should always share ideas or ask questions to better understand the study in which they are participating.

Panel member Andy Lee, SVP Head of Global Clinical Trial Operations at Merck, said he appreciates AWARE for All’s focus on patient education, evaluating the decision to participate, and fully understanding what it means to participate because that underscores the philosophy of clinical research: patient safety is the first tenet of medical research.

“Our medical advances can only happen through the efforts of many people, especially the patients who volunteer for clinical trials. They are our partners in research,” said Lee.

CISCRP is a non-profit organization dedicated to educating the general population and patient communities about clinical participation. They work with local advocates around the country to plan and host educational events about the clinical research process. Anyone interested in learning more about participating in clinical trials can obtain information from CISCRP at 1-877-MED-HERO or www.ciscrp.org.

CISCRP offers a free service designed to help patients and caregivers find clinical trials within their medical condition and location at www.searchclinicaltrials.org. CISCRP also recommends that individuals consult with a trusted health professional for more information and review key websites devoted to clinical trials:

  • ClinicalTrials.gov is a site maintained by the National Institutes of Health (NIH) that includes trial and enrollment information.

CISCRP recently launched informational videos about the different phases of clinical research participation and highlights why it takes so long to develop new therapies. The first video of the series can be viewed here: https://www.youtube.com/watch?v=iid3BMqopMM.

Supporters of the AWARE for All – Philadelphia event include Albert Einstein Healthcare Network, Drexel University College of Medicine, Greenphire, Lazarex Cancer Foundation, National Alliance on Mental Health – Montgomery County chapter, Allergy & Asthma Network, Fox Chase Cancer Center, TREND Community and the AWARE Industry Consortium.

About CISCRP

The Center for Information and Study on Clinical Research Participation (CISCRP) is a 501(c)(3) non-profit organization dedicated to engaging the public and patients as partners in the clinical research process. Visit www.CISCRP.org for more information or to participate in CISCRP’s educational initiatives. For additional questions about AWARE for All, contact awareforall@ciscrp.org or call 877-633-4376.