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Plain Language Summaries & Patient Engagement in Pediatrics

2021 年 8 月 25 日

Plain language summaries (PLS) of clinical trial results ensure that study participants are informed about study results and that they understand the value of their contribution to science and public health. Patient engagement is key to support PLS development. Factoring patient insights and experience into PLS development drives improvement of PLS quality, readability, and comprehension.

This webinar discussed a recently developed online patient engagement portal to enable patients to provide direct feedback on PLS. Results of surveys taken by reviewers in this portal were be presented. We included perspectives on partnering with patient advocacy groups to ensure that patients can comment and assess the readability of PLS. This webinar focused on the pediatric PLS space, with consideration given to the cognitive development and unique needs and perceptions of children and young people. A model for pediatric patient engagement and PLS development was presented and discussed. By building this level of engagement, sponsors can not only advance clinical research and meet data transparency and disclosure requirements, but also foster closer relationships with the patient community in both the adult and pediatric arenas.


Amy Ohmer, Director of the International Children’s Advisory Network, Inc. (iCAN)

Ms. Ohmer specializes in creating collaboration through patient-centered programs by focusing on the needs of patients/families as partners within research and medical communities. Amy’s efforts include engaging the unique population of children living with chronic, rare, and complicated medical conditions through community building for adolescents, providers, clinicians, and caregivers. She is an active advocate for clinical research leading to better outcomes through co-design within the T1D Exchange as Co-Chair of the Patient/Family Advisory Board, C.S. Mott Children’s Hospital Patient/Family Advisory Council (PFAC) at Michigan Medicine, and as a patient advocate for the American Diabetes Association Call to Congress/ Camp Midicha and JDRF Teen Central. In 2019, Amy was the recipient of the Sally Joy Award from the State of Michigan Diabetes Patient Advocacy Council and in 2020, Amy received the T1D Outstanding Patient Advocate Award from the T1D Exchange. With a BA from Michigan State University in Advertising, Communications Arts and Science, Amy brings a passion for engaging audiences by offering open communication by utilizing social networks, technology, and marketing to strengthen the pediatric patient community. Amy is a mom to two children, both diagnosed with T1D at young ages.  She enjoys spending time with her family and enjoying the outdoor beauty of her home state of Michigan.

Theresa Shalaby, Senior Manager, Regulatory Services, Certara

Ms. Shalaby has over 30 years of experience in the clinical research and drug development industry. Throughout that time,, she held several writing roles including lead author and contributing writer for investigator’s brochures (IBs), phase 2 and phase 3 clinical study reports (CSRs), investigational new drug applications (INDs), new drug applications (NDAs), study protocols, informed consent forms (ICFs), and plain language summaries (PLS). She has experience in the therapeutic areas of pediatrics, neonatology, pediatric and adult oncology, hematology, gastroenterology, pulmonary and respiratory diseases, genetic diseases, cardiology, multiple sclerosis, and rare diseases. She is the functional lead for PLS at Certara Synchrogenix. 

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