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

Survey conducted by CISCRP (Center for Information and Study on Clinical Research Participation) and commissioned by Parexel shows perceptions of clinical research are positive but logistical burdens limit children's participation.


News provided by

CISCRP

Dec 08, 2020, 10:15 ET

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BOSTON, Dec. 8, 2020 /PRNewswire-PRWeb/ -- 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.

“Understanding patient health journeys and study volunteer experiences is critical to designing more patient-friendly trials that ultimately enhance pediatric patient participation,” said Ken Getz, Founder and Chairman at CISCRP.

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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, visit https://www.ciscrp.org/wp-content/uploads/2020/09/Pediatric-PI-Survey-FINAL-2020.pdf

To hear a podcast about the survey results featuring a parent advocate survey respondent, please visit https://www.podbean.com/media/player/t2u24-f45cc0?from=pb6admin&download=1&version=1&auto=0&share=1&download=0&rtl=0&fonts=Helvetica&skin=1&pfauth=&btn-skin=107

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
###

Media Contact

Joan A. Chambers, CISCRP, 617-725-2750 x202, [email protected]

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SOURCE CISCRP

Related Links

http://CISCRP.org

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