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Exploring Barriers to Pediatric Cancer Clinical Trials: The Role of a Networked, Just-in-Time Study Program
•Tempus TIME for Kids brings the Just-in-Time trial model to pediatric cancer.•TIME for Kids modifies the TIME Program originally created for adults.•The program addresses barriers in pediatric cancer drug development. The Research to Accelerate Cures and Equity (RACE) for Children Act mandates that...
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| Published in: | Clinical therapeutics 2023-11, Vol.45 (11), p.1148-1150 |
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| Main Authors: | , , , , , , , , , |
| Format: | Article |
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| cited_by | cdi_FETCH-LOGICAL-c448t-48c0fcc53e252a8b0725d9e0aaff437b4f4c7c6969c384cc17650bae213b94583 |
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| cites | cdi_FETCH-LOGICAL-c448t-48c0fcc53e252a8b0725d9e0aaff437b4f4c7c6969c384cc17650bae213b94583 |
| container_end_page | 1150 |
| container_issue | 11 |
| container_start_page | 1148 |
| container_title | Clinical therapeutics |
| container_volume | 45 |
| creator | Rivers, Zachary Hyde, Ben Ronski, Karyn Stearns, Duncan Toll, Stephanie Ritt, Kevin Cooney, Matthew Nimeiri, Halla Federman, Noah Kaneva, Kristiyana |
| description | •Tempus TIME for Kids brings the Just-in-Time trial model to pediatric cancer.•TIME for Kids modifies the TIME Program originally created for adults.•The program addresses barriers in pediatric cancer drug development.
The Research to Accelerate Cures and Equity (RACE) for Children Act mandates that newly developed targeted oncology drugs be tested in children when molecular targets are relevant to pediatric cancers. In its first year, the RACE for Children Act was effective in creating novel drug development opportunities for children with cancer; however, significant barriers to clinical trial enrollment persist. Pediatric cancer clinical trials are impacted by challenges surrounding logistics, complexity, and access. As such, there is potential for a networked and centralized study approach to address these barriers. Here we discuss adapting a just-in-time clinical trial approach for adults to serve the pediatric oncology population. Through innovative patient matching solutions leveraging large, real-world datasets with high computational power, the Tempus Integrated Molecular Evaluation (TIME) for Kids Program aims to address barriers in the development of new therapies. This commentary explores the potential for reducing challenges in developing novel pediatric therapeutics, advancing equity in genomic biomarker testing for precision tailored treatment, and improving outcomes for pediatric oncology patients. |
| doi_str_mv | 10.1016/j.clinthera.2023.08.022 |
| format | article |
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The Research to Accelerate Cures and Equity (RACE) for Children Act mandates that newly developed targeted oncology drugs be tested in children when molecular targets are relevant to pediatric cancers. In its first year, the RACE for Children Act was effective in creating novel drug development opportunities for children with cancer; however, significant barriers to clinical trial enrollment persist. Pediatric cancer clinical trials are impacted by challenges surrounding logistics, complexity, and access. As such, there is potential for a networked and centralized study approach to address these barriers. Here we discuss adapting a just-in-time clinical trial approach for adults to serve the pediatric oncology population. Through innovative patient matching solutions leveraging large, real-world datasets with high computational power, the Tempus Integrated Molecular Evaluation (TIME) for Kids Program aims to address barriers in the development of new therapies. This commentary explores the potential for reducing challenges in developing novel pediatric therapeutics, advancing equity in genomic biomarker testing for precision tailored treatment, and improving outcomes for pediatric oncology patients.</description><identifier>ISSN: 0149-2918</identifier><identifier>EISSN: 1879-114X</identifier><identifier>DOI: 10.1016/j.clinthera.2023.08.022</identifier><identifier>PMID: 37783645</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adult ; Biomarkers ; Biomarkers, Tumor - therapeutic use ; Cancer ; Child ; Children ; Clinical trials ; Collaboration ; Drug Development ; Editing ; Enrollments ; Equity ; Humans ; Just in time ; Medical Oncology ; Molecular oncology ; Neoplasms - drug therapy ; Neoplasms - genetics ; Oncology ; Patients ; Pediatric cancer ; Pediatrics ; Supervision ; Targeted therapy ; Time and Motion Studies ; Writing</subject><ispartof>Clinical therapeutics, 2023-11, Vol.45 (11), p.1148-1150</ispartof><rights>2023 The Authors</rights><rights>Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.</rights><rights>2023. The Authors</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c448t-48c0fcc53e252a8b0725d9e0aaff437b4f4c7c6969c384cc17650bae213b94583</citedby><cites>FETCH-LOGICAL-c448t-48c0fcc53e252a8b0725d9e0aaff437b4f4c7c6969c384cc17650bae213b94583</cites><orcidid>0000-0002-4957-4908</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,786,790,27957,27958</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37783645$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rivers, Zachary</creatorcontrib><creatorcontrib>Hyde, Ben</creatorcontrib><creatorcontrib>Ronski, Karyn</creatorcontrib><creatorcontrib>Stearns, Duncan</creatorcontrib><creatorcontrib>Toll, Stephanie</creatorcontrib><creatorcontrib>Ritt, Kevin</creatorcontrib><creatorcontrib>Cooney, Matthew</creatorcontrib><creatorcontrib>Nimeiri, Halla</creatorcontrib><creatorcontrib>Federman, Noah</creatorcontrib><creatorcontrib>Kaneva, Kristiyana</creatorcontrib><title>Exploring Barriers to Pediatric Cancer Clinical Trials: The Role of a Networked, Just-in-Time Study Program</title><title>Clinical therapeutics</title><addtitle>Clin Ther</addtitle><description>•Tempus TIME for Kids brings the Just-in-Time trial model to pediatric cancer.•TIME for Kids modifies the TIME Program originally created for adults.•The program addresses barriers in pediatric cancer drug development.
The Research to Accelerate Cures and Equity (RACE) for Children Act mandates that newly developed targeted oncology drugs be tested in children when molecular targets are relevant to pediatric cancers. In its first year, the RACE for Children Act was effective in creating novel drug development opportunities for children with cancer; however, significant barriers to clinical trial enrollment persist. Pediatric cancer clinical trials are impacted by challenges surrounding logistics, complexity, and access. As such, there is potential for a networked and centralized study approach to address these barriers. Here we discuss adapting a just-in-time clinical trial approach for adults to serve the pediatric oncology population. Through innovative patient matching solutions leveraging large, real-world datasets with high computational power, the Tempus Integrated Molecular Evaluation (TIME) for Kids Program aims to address barriers in the development of new therapies. This commentary explores the potential for reducing challenges in developing novel pediatric therapeutics, advancing equity in genomic biomarker testing for precision tailored treatment, and improving outcomes for pediatric oncology patients.</description><subject>Adult</subject><subject>Biomarkers</subject><subject>Biomarkers, Tumor - therapeutic use</subject><subject>Cancer</subject><subject>Child</subject><subject>Children</subject><subject>Clinical trials</subject><subject>Collaboration</subject><subject>Drug Development</subject><subject>Editing</subject><subject>Enrollments</subject><subject>Equity</subject><subject>Humans</subject><subject>Just in time</subject><subject>Medical Oncology</subject><subject>Molecular oncology</subject><subject>Neoplasms - drug therapy</subject><subject>Neoplasms - genetics</subject><subject>Oncology</subject><subject>Patients</subject><subject>Pediatric cancer</subject><subject>Pediatrics</subject><subject>Supervision</subject><subject>Targeted therapy</subject><subject>Time and Motion Studies</subject><subject>Writing</subject><issn>0149-2918</issn><issn>1879-114X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><recordid>eNqFkc1u1DAYRS0EotPCK4AlNixI8F9im10ZlT9VUMEgsbMc50vraRIPtlPo2-PRlC7YsPLm3PtZ9yD0nJKaEtq-3tZu9HO-gmhrRhiviaoJYw_QiiqpK0rFj4doRajQFdNUHaHjlLaEEK4b9hgdcSkVb0WzQtdnv3djiH6-xG9tjB5iwjngC-i9zdE7vLazg4jX5Zx3dsSb6O2Y3uDNFeCvYQQcBmzxZ8i_QryG_hX-tKRc-bna-Anwt7z0t_gihstopyfo0VCy8PTuPUHf351t1h-q8y_vP65PzysnhMqVUI4MzjUcWMOs6ohkTa-BWDsMgstODMJJ1-pWO66Ec1S2DeksMMo7LRrFT9DLQ-8uhp8LpGwmnxyMo50hLMkwJRlVlEpa0Bf_oNuwxLn8rlCaEU413xfKA-ViSCnCYHbRTzbeGkrM3ofZmnsfZu_DEGWKj5J8dte_dBP097m_AgpwegCgDHJT5jfJeSiT9z6Cy6YP_r9H_gA0AJ9c</recordid><startdate>202311</startdate><enddate>202311</enddate><creator>Rivers, Zachary</creator><creator>Hyde, Ben</creator><creator>Ronski, Karyn</creator><creator>Stearns, Duncan</creator><creator>Toll, Stephanie</creator><creator>Ritt, Kevin</creator><creator>Cooney, Matthew</creator><creator>Nimeiri, Halla</creator><creator>Federman, Noah</creator><creator>Kaneva, Kristiyana</creator><general>Elsevier Inc</general><general>Elsevier Limited</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M7N</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-4957-4908</orcidid></search><sort><creationdate>202311</creationdate><title>Exploring Barriers to Pediatric Cancer Clinical Trials: The Role of a Networked, Just-in-Time Study Program</title><author>Rivers, Zachary ; Hyde, Ben ; Ronski, Karyn ; Stearns, Duncan ; Toll, Stephanie ; Ritt, Kevin ; Cooney, Matthew ; Nimeiri, Halla ; Federman, Noah ; Kaneva, Kristiyana</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c448t-48c0fcc53e252a8b0725d9e0aaff437b4f4c7c6969c384cc17650bae213b94583</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Adult</topic><topic>Biomarkers</topic><topic>Biomarkers, Tumor - therapeutic use</topic><topic>Cancer</topic><topic>Child</topic><topic>Children</topic><topic>Clinical trials</topic><topic>Collaboration</topic><topic>Drug Development</topic><topic>Editing</topic><topic>Enrollments</topic><topic>Equity</topic><topic>Humans</topic><topic>Just in time</topic><topic>Medical Oncology</topic><topic>Molecular oncology</topic><topic>Neoplasms - drug therapy</topic><topic>Neoplasms - genetics</topic><topic>Oncology</topic><topic>Patients</topic><topic>Pediatric cancer</topic><topic>Pediatrics</topic><topic>Supervision</topic><topic>Targeted therapy</topic><topic>Time and Motion Studies</topic><topic>Writing</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rivers, Zachary</creatorcontrib><creatorcontrib>Hyde, Ben</creatorcontrib><creatorcontrib>Ronski, Karyn</creatorcontrib><creatorcontrib>Stearns, Duncan</creatorcontrib><creatorcontrib>Toll, Stephanie</creatorcontrib><creatorcontrib>Ritt, Kevin</creatorcontrib><creatorcontrib>Cooney, Matthew</creatorcontrib><creatorcontrib>Nimeiri, Halla</creatorcontrib><creatorcontrib>Federman, Noah</creatorcontrib><creatorcontrib>Kaneva, Kristiyana</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>PML(ProQuest Medical Library)</collection><collection>Research Library</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rivers, Zachary</au><au>Hyde, Ben</au><au>Ronski, Karyn</au><au>Stearns, Duncan</au><au>Toll, Stephanie</au><au>Ritt, Kevin</au><au>Cooney, Matthew</au><au>Nimeiri, Halla</au><au>Federman, Noah</au><au>Kaneva, Kristiyana</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Exploring Barriers to Pediatric Cancer Clinical Trials: The Role of a Networked, Just-in-Time Study Program</atitle><jtitle>Clinical therapeutics</jtitle><addtitle>Clin Ther</addtitle><date>2023-11</date><risdate>2023</risdate><volume>45</volume><issue>11</issue><spage>1148</spage><epage>1150</epage><pages>1148-1150</pages><issn>0149-2918</issn><eissn>1879-114X</eissn><notes>ObjectType-Article-1</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-Feature-2</notes><notes>content type line 23</notes><abstract>•Tempus TIME for Kids brings the Just-in-Time trial model to pediatric cancer.•TIME for Kids modifies the TIME Program originally created for adults.•The program addresses barriers in pediatric cancer drug development.
The Research to Accelerate Cures and Equity (RACE) for Children Act mandates that newly developed targeted oncology drugs be tested in children when molecular targets are relevant to pediatric cancers. In its first year, the RACE for Children Act was effective in creating novel drug development opportunities for children with cancer; however, significant barriers to clinical trial enrollment persist. Pediatric cancer clinical trials are impacted by challenges surrounding logistics, complexity, and access. As such, there is potential for a networked and centralized study approach to address these barriers. Here we discuss adapting a just-in-time clinical trial approach for adults to serve the pediatric oncology population. Through innovative patient matching solutions leveraging large, real-world datasets with high computational power, the Tempus Integrated Molecular Evaluation (TIME) for Kids Program aims to address barriers in the development of new therapies. This commentary explores the potential for reducing challenges in developing novel pediatric therapeutics, advancing equity in genomic biomarker testing for precision tailored treatment, and improving outcomes for pediatric oncology patients.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>37783645</pmid><doi>10.1016/j.clinthera.2023.08.022</doi><tpages>3</tpages><orcidid>https://orcid.org/0000-0002-4957-4908</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Clinical therapeutics, 2023-11, Vol.45 (11), p.1148-1150 |
| issn | 0149-2918 1879-114X |
| language | eng |
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| source | ScienceDirect Journals |
| subjects | Adult Biomarkers Biomarkers, Tumor - therapeutic use Cancer Child Children Clinical trials Collaboration Drug Development Editing Enrollments Equity Humans Just in time Medical Oncology Molecular oncology Neoplasms - drug therapy Neoplasms - genetics Oncology Patients Pediatric cancer Pediatrics Supervision Targeted therapy Time and Motion Studies Writing |
| title | Exploring Barriers to Pediatric Cancer Clinical Trials: The Role of a Networked, Just-in-Time Study Program |
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