[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-0-en-105":3,"doc-seo-231475-105":59,"doc-detail-231475-en":130},{"code":4,"msg":5,"data":6},0,"success",[7,13,18,23,28,33,38,43,48,51,55],{"id":8,"doc_module":4,"doc_module_name":9,"category_name":10,"show_sort_weight":11,"slug":12},1,"Document","Story & Novel",90,"story-novel",{"id":14,"doc_module":4,"doc_module_name":9,"category_name":15,"show_sort_weight":16,"slug":17},2,"Literature",80,"literature",{"id":19,"doc_module":4,"doc_module_name":9,"category_name":20,"show_sort_weight":21,"slug":22},4,"Exam",70,"exam",{"id":24,"doc_module":4,"doc_module_name":9,"category_name":25,"show_sort_weight":26,"slug":27},5,"Comic",60,"comic",{"id":29,"doc_module":4,"doc_module_name":9,"category_name":30,"show_sort_weight":31,"slug":32},6,"Technology",50,"technology",{"id":34,"doc_module":4,"doc_module_name":9,"category_name":35,"show_sort_weight":36,"slug":37},7,"Healthcare",40,"healthcare",{"id":39,"doc_module":4,"doc_module_name":9,"category_name":40,"show_sort_weight":41,"slug":42},8,"Research & Report",30,"research-report",{"id":44,"doc_module":4,"doc_module_name":9,"category_name":45,"show_sort_weight":46,"slug":47},9,"Religion & Spirituality",20,"religion-spirituality",{"id":46,"doc_module":4,"doc_module_name":9,"category_name":49,"show_sort_weight":46,"slug":50},"World Cup","world-cup",{"id":52,"doc_module":4,"doc_module_name":9,"category_name":53,"show_sort_weight":52,"slug":54},10,"Lifestyle","lifestyle",{"id":56,"doc_module":4,"doc_module_name":9,"category_name":57,"show_sort_weight":24,"slug":58},19,"General","general",{"code":4,"msg":60,"data":61},"ok",{"site_id":62,"language":63,"slug":64,"title":65,"keywords":66,"description":67,"schema_data":68,"social_meta":123,"head_meta":125,"extra_data":127,"updated_unix":129},105,"en","the-annual-review-2021-2022-ptn-achievements-and-research-highlights","THE ANNUAL REVIEW 2021-2022 - PTN Achievements and Research Highlights","","Annual Review covering the Pediatric Trials Network (PTN) mission to improve children’s health through research, participant engagement, and science sharing across 2021–2022. Details progress in FDA label changes supported by PTN-conducted studies under the Best Pharmaceuticals for Children Act, highlights ongoing clinical trials and submitted clinical study reports, and explains how results guide future pediatric dosing evidence. Also addresses diversity initiatives, including participant input on diversity meaning, feedback on assent forms, creative anthology development, and personalized thank-you notes.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":40,"@type":76,"position":81},"https://docshare.wps.com/document/research-report/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/the-annual-review-2021-2022-ptn-achievements-and-research-highlights/231475/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/the-annual-review-2021-2022-ptn-achievements-and-research-highlights/231475.png","ImageObject",300,407,{"name":92,"@type":93},"Felix Montgomery","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-11-03","2026-09-10",true,{"@type":102,"interactionType":103,"userInteractionCount":29},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What impact did PTN research have on FDA drug and device labels in 2022?","Question",{"text":112,"@type":113},"PTN research informed label changes by providing FDA with dosing and usage guidance for children. Clinical study reports submitted in 2022 supported additional label updates.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"Which ongoing PTN studies were active in 2022, and what do they cover?",{"text":117,"@type":113},"PTN had five ongoing studies in 2022, spanning topics including COVID-19 treatment, anesthetics, lactation and infant exposure, long-term antipsychotic safety, and sildenafil enrollment for infants.",{"name":119,"@type":110,"acceptedAnswer":120},"How did PTN approach diversity and participant engagement during 2022?",{"text":121,"@type":113},"PTN engaged pediatric participants by asking how they define diversity in pediatric clinical research and by involving them in developing clinical trial assent forms. It also created a participant anthology and sent personalized thank-you notes to participants and families.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},231475,1789065568,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":39,"category_name":40,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":29,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":24,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":129,"read_time":143,"preview_page_count":4},549768064778,"https://ap-avatar.wpscdn.com/davatar_6f874abed73319feea01a86fa6f0fab8","THE ANNUAL REVIEW  \n2021–2022  \nA MESSAGE FROM PTN LEADERSHIP  \nDanny Benjamin, MD, PhD, MPH  \nPTN Lead Principal Investigator  \nRachel Greenberg, MD, MB, MHS  \nPTN Steering Committee Chair  \nIn 2022, the Pediatric Trials Network (PTN) carried out its mission to improve health for all children by performing research, engaging participants, and sharing science. To date, the PTN has informed 17 label changes for drugs and devices to include dosing/usage guidance for children. Clinical study reports on several drugs were submitted to the FDA this year and will be used to inform more label changes. The PTN had five ongoing studies in 2022, which address topics like COVID-19 treatment, anesthetics, and drug dosages for participants ranging from infants, to 21-year-olds, to breastfeeding mothers. The Sildenafil study in particular has enrolled over 80 infants across two cohorts, and is expecting to open another cohort soon.  \nIn addition to the upcoming Sildenafil cohort, the PTN is expecting to open three new studies in 2023. Two of these studies will be a bit different than what we’re used to, because they will involve adult participants. One will study intravenous methadone in healthy adults (MTH02), and the other will study terbutaline sulfate in adults with asthma (TBS02) . The answers learned from these clinical trials will inform the development of trials for pediatric participants. The third study enrolling in 2023 will evaluate guanfacine for children with Down Syndrome (HYP01) .  \nSince last year’s report, the PTN has released nine new publications to share these important data with the scientific community. We also developed a Results-at-a-Glance webpage to be the home of quick, easy-to-read study summaries that can be shared with the public and study participants.  \nDiversity and participant engagement were also a big focus of the PTN in 2022. We engaged pediatric participants by asking them what diversity in pediatric clinical research means to them, as well as directly involving them with the development of clinical trials by allowing them to provide feedback on clinical trial assent forms. We developed an anthology of creative works by pediatric trial participants to spotlight their voices and experiences. Additionally, we showed gratitude to participants and their families by developing and sending personalized thank-you notes.  \nContinue reading this Annual Review for more details on these accomplishments. We look forward to an exciting 2023 and thank you for your commitment to determining the safest and most effective medications and devices for children.  \nDanny Benjamin, MD, PhD, MPH  \nPediatric Trials Network, Principal Investigator  \nRachel Greenberg, MD, MB, MHS  \nPediatric Trials Network, Steering Committee Chair  \n THIS YEAR PTN…PERFORMED RESEARCH  \nPTN Label Changes to Date  \nUnder the Best Pharmaceuticals for Children Act (BPCA), the PTN works to provide the United States Food and Drug Administration (FDA) with research and data to inform label changes so that health care providers can prescribe the most appropriate doses of medications to children. As a result of research conducted through the BPCA program, led by the PTN, the following label changes have been made:  \n• Acyclovir  \n• Ampicillin  \n• Caffeine  \n• Clindamycin (2)  \n• Diazepam  \n• Doxycycline  \n• Lisinopril  \n• Lithium  \n• Lorazepam  \n• Mercy babyTAPE  \n• 2D and 3D Mercy TAPE  \n• Meropenem  \n• Propylthiouracil  \n• Pralidoxime  \n• Sodium nitroprusside  \nOngoing PTN Studies  \nPTN has five ongoing studies, four of which are enrolling and one that is in the follow-up phase. Pediatric participants of these studies range in age from infants to 21 years old, and we have also enrolled breastfeeding mothers. Through these studies, PTN continues to generate evidence to advise dosing of medications commonly used in children.  \n• Anesthetics and Analgesics in Children (ANA)  \n• Commonly used drugs during lactation and infant  exposure (CUDDLE)  \n• Long-t","cbCaiqJDOwOaWWWa","https://ap.wps.com/l/cbCaiqJDOwOaWWWa","pdf",597826,"English","# A Message From PTN Leadership\n# This Year PTN Performed Research\n## PTN Label Changes to Date\n## Ongoing PTN Studies\n## Clinical Study Reports Submitted\n# Diversity and Participant Engagement","[{\"question\":\"What impact did PTN research have on FDA drug and device labels in 2022?\",\"answer\":\"PTN research informed label changes by providing FDA with dosing and usage guidance for children. Clinical study reports submitted in 2022 supported additional label updates.\"},{\"question\":\"Which ongoing PTN studies were active in 2022, and what do they cover?\",\"answer\":\"PTN had five ongoing studies in 2022, spanning topics including COVID-19 treatment, anesthetics, lactation and infant exposure, long-term antipsychotic safety, and sildenafil enrollment for infants.\"},{\"question\":\"How did PTN approach diversity and participant engagement during 2022?\",\"answer\":\"PTN engaged pediatric participants by asking how they define diversity in pediatric clinical research and by involving them in developing clinical trial assent forms. It also created a participant anthology and sent personalized thank-you notes to participants and families.\"}]","THE ANNUAL REVIEW 2021-2022 - PTN Achievements and Research Highlights | PDF",13]