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.

 

 

Pediatric Perceptions & Insights on Clinical Trial Participation

In this November 2020 podcast, the results of a survey of 500 parents and children in the United States, conducted by CISCRP and commissioned by Parexel, are discussed. Key findings include determinants, motivations, barriers  to clinical trial participation and issues surrounding diversity in clinical research. Annick de Bruin, Senior Director, Research Services, CISCRP, moderates.

Register here to access the podcast.

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.