Development of a Prospective Real‐World Data Clinical Registry of Children and Adolescents With Migraine
Objective To develop a multicenter, multistakeholder, prospective clinical registry of children and adolescents with migraine to support the collection of real‐world data of sufficient quality to support regulatory submissions and provide site‐based infrastructure support for future clinical trials....
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| Published in: | Headache Vol. 60; no. 2; pp. 405 - 415 |
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| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
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United States
Wiley Subscription Services, Inc
01-02-2020
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| Abstract | Objective
To develop a multicenter, multistakeholder, prospective clinical registry of children and adolescents with migraine to support the collection of real‐world data of sufficient quality to support regulatory submissions and provide site‐based infrastructure support for future clinical trials.
Background
As new migraine treatments come to market, pediatric efficacy and safety trials of these agents are needed. A clinical registry is an ideal regulatory strategy to provide both real‐world data and site infrastructure to execute these trials.
Design
Multicenter, multistakeholder, prospective real‐world data clinical registry of children and adolescents, 4‐17 years of age, diagnosed with migraine with or without aura. Participants will be followed for up to 12 months at 3‐month intervals, with interval recording of clinical data at study sites and self‐reported data via mobile health application, as well as biobanking. We developed electronic case report forms that incorporated routinely collected clinical data with National Institute of Neurological Disorders and Stroke Headache Common Data Elements (Version 2.0). All data are captured in a 21 CFR Part 11 – compliant electronic data capture system – augmented by a real‐time, web‐based, and customizable data visualization platform. We engaged vendors to provide ancillary biobanking, patient data entry, and data visualization services.
Results
We used an iterative and highly collaborative multistakeholder approach to design and implement a streamlined registry protocol with input from all participating US sites. At each design and implementation step, we received input from therapeutic area experts, the US Food and Drug Administration (FDA), the National Institutes of Health, patient and parent advocates, health technology partners, drug developers, and site‐based clinical investigators. The registry is governed by a multistakeholder steering committee with representation from sites, industry partners, patient advocates, and a member from the FDA (non‐voting with respect to steering committee matters). The multistakeholder and site‐driven approach to registry design and execution was highly efficient and resulted in the first patient enrolled within 6 months of concept development.
Conclusions
By ensuring regulatory compliant implementation of the registry, we created both a source of real‐world data and a multisite platform for the conduct of future clinical trials that can be submitted to regulatory authorities to support inclusion of pediatric data in approved drug labeling. A highly collaborative approach with broad stakeholder engagement at all stages of the registry development was a key to our operational success. |
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| AbstractList | To develop a multicenter, multistakeholder, prospective clinical registry of children and adolescents with migraine to support the collection of real-world data of sufficient quality to support regulatory submissions and provide site-based infrastructure support for future clinical trials.
As new migraine treatments come to market, pediatric efficacy and safety trials of these agents are needed. A clinical registry is an ideal regulatory strategy to provide both real-world data and site infrastructure to execute these trials.
Multicenter, multistakeholder, prospective real-world data clinical registry of children and adolescents, 4-17 years of age, diagnosed with migraine with or without aura. Participants will be followed for up to 12 months at 3-month intervals, with interval recording of clinical data at study sites and self-reported data via mobile health application, as well as biobanking. We developed electronic case report forms that incorporated routinely collected clinical data with National Institute of Neurological Disorders and Stroke Headache Common Data Elements (Version 2.0). All data are captured in a 21 CFR Part 11 - compliant electronic data capture system - augmented by a real-time, web-based, and customizable data visualization platform. We engaged vendors to provide ancillary biobanking, patient data entry, and data visualization services.
We used an iterative and highly collaborative multistakeholder approach to design and implement a streamlined registry protocol with input from all participating US sites. At each design and implementation step, we received input from therapeutic area experts, the US Food and Drug Administration (FDA), the National Institutes of Health, patient and parent advocates, health technology partners, drug developers, and site-based clinical investigators. The registry is governed by a multistakeholder steering committee with representation from sites, industry partners, patient advocates, and a member from the FDA (non-voting with respect to steering committee matters). The multistakeholder and site-driven approach to registry design and execution was highly efficient and resulted in the first patient enrolled within 6 months of concept development.
By ensuring regulatory compliant implementation of the registry, we created both a source of real-world data and a multisite platform for the conduct of future clinical trials that can be submitted to regulatory authorities to support inclusion of pediatric data in approved drug labeling. A highly collaborative approach with broad stakeholder engagement at all stages of the registry development was a key to our operational success. ObjectiveTo develop a multicenter, multistakeholder, prospective clinical registry of children and adolescents with migraine to support the collection of real‐world data of sufficient quality to support regulatory submissions and provide site‐based infrastructure support for future clinical trials.BackgroundAs new migraine treatments come to market, pediatric efficacy and safety trials of these agents are needed. A clinical registry is an ideal regulatory strategy to provide both real‐world data and site infrastructure to execute these trials.DesignMulticenter, multistakeholder, prospective real‐world data clinical registry of children and adolescents, 4‐17 years of age, diagnosed with migraine with or without aura. Participants will be followed for up to 12 months at 3‐month intervals, with interval recording of clinical data at study sites and self‐reported data via mobile health application, as well as biobanking. We developed electronic case report forms that incorporated routinely collected clinical data with National Institute of Neurological Disorders and Stroke Headache Common Data Elements (Version 2.0). All data are captured in a 21 CFR Part 11 – compliant electronic data capture system – augmented by a real‐time, web‐based, and customizable data visualization platform. We engaged vendors to provide ancillary biobanking, patient data entry, and data visualization services.ResultsWe used an iterative and highly collaborative multistakeholder approach to design and implement a streamlined registry protocol with input from all participating US sites. At each design and implementation step, we received input from therapeutic area experts, the US Food and Drug Administration (FDA), the National Institutes of Health, patient and parent advocates, health technology partners, drug developers, and site‐based clinical investigators. The registry is governed by a multistakeholder steering committee with representation from sites, industry partners, patient advocates, and a member from the FDA (non‐voting with respect to steering committee matters). The multistakeholder and site‐driven approach to registry design and execution was highly efficient and resulted in the first patient enrolled within 6 months of concept development.ConclusionsBy ensuring regulatory compliant implementation of the registry, we created both a source of real‐world data and a multisite platform for the conduct of future clinical trials that can be submitted to regulatory authorities to support inclusion of pediatric data in approved drug labeling. A highly collaborative approach with broad stakeholder engagement at all stages of the registry development was a key to our operational success. Objective To develop a multicenter, multistakeholder, prospective clinical registry of children and adolescents with migraine to support the collection of real‐world data of sufficient quality to support regulatory submissions and provide site‐based infrastructure support for future clinical trials. Background As new migraine treatments come to market, pediatric efficacy and safety trials of these agents are needed. A clinical registry is an ideal regulatory strategy to provide both real‐world data and site infrastructure to execute these trials. Design Multicenter, multistakeholder, prospective real‐world data clinical registry of children and adolescents, 4‐17 years of age, diagnosed with migraine with or without aura. Participants will be followed for up to 12 months at 3‐month intervals, with interval recording of clinical data at study sites and self‐reported data via mobile health application, as well as biobanking. We developed electronic case report forms that incorporated routinely collected clinical data with National Institute of Neurological Disorders and Stroke Headache Common Data Elements (Version 2.0). All data are captured in a 21 CFR Part 11 – compliant electronic data capture system – augmented by a real‐time, web‐based, and customizable data visualization platform. We engaged vendors to provide ancillary biobanking, patient data entry, and data visualization services. Results We used an iterative and highly collaborative multistakeholder approach to design and implement a streamlined registry protocol with input from all participating US sites. At each design and implementation step, we received input from therapeutic area experts, the US Food and Drug Administration (FDA), the National Institutes of Health, patient and parent advocates, health technology partners, drug developers, and site‐based clinical investigators. The registry is governed by a multistakeholder steering committee with representation from sites, industry partners, patient advocates, and a member from the FDA (non‐voting with respect to steering committee matters). The multistakeholder and site‐driven approach to registry design and execution was highly efficient and resulted in the first patient enrolled within 6 months of concept development. Conclusions By ensuring regulatory compliant implementation of the registry, we created both a source of real‐world data and a multisite platform for the conduct of future clinical trials that can be submitted to regulatory authorities to support inclusion of pediatric data in approved drug labeling. A highly collaborative approach with broad stakeholder engagement at all stages of the registry development was a key to our operational success. To develop a multicenter, multistakeholder, prospective clinical registry of children and adolescents with migraine to support the collection of real-world data of sufficient quality to support regulatory submissions and provide site-based infrastructure support for future clinical trials.OBJECTIVETo develop a multicenter, multistakeholder, prospective clinical registry of children and adolescents with migraine to support the collection of real-world data of sufficient quality to support regulatory submissions and provide site-based infrastructure support for future clinical trials.As new migraine treatments come to market, pediatric efficacy and safety trials of these agents are needed. A clinical registry is an ideal regulatory strategy to provide both real-world data and site infrastructure to execute these trials.BACKGROUNDAs new migraine treatments come to market, pediatric efficacy and safety trials of these agents are needed. A clinical registry is an ideal regulatory strategy to provide both real-world data and site infrastructure to execute these trials.Multicenter, multistakeholder, prospective real-world data clinical registry of children and adolescents, 4-17 years of age, diagnosed with migraine with or without aura. Participants will be followed for up to 12 months at 3-month intervals, with interval recording of clinical data at study sites and self-reported data via mobile health application, as well as biobanking. We developed electronic case report forms that incorporated routinely collected clinical data with National Institute of Neurological Disorders and Stroke Headache Common Data Elements (Version 2.0). All data are captured in a 21 CFR Part 11 - compliant electronic data capture system - augmented by a real-time, web-based, and customizable data visualization platform. We engaged vendors to provide ancillary biobanking, patient data entry, and data visualization services.DESIGNMulticenter, multistakeholder, prospective real-world data clinical registry of children and adolescents, 4-17 years of age, diagnosed with migraine with or without aura. Participants will be followed for up to 12 months at 3-month intervals, with interval recording of clinical data at study sites and self-reported data via mobile health application, as well as biobanking. We developed electronic case report forms that incorporated routinely collected clinical data with National Institute of Neurological Disorders and Stroke Headache Common Data Elements (Version 2.0). All data are captured in a 21 CFR Part 11 - compliant electronic data capture system - augmented by a real-time, web-based, and customizable data visualization platform. We engaged vendors to provide ancillary biobanking, patient data entry, and data visualization services.We used an iterative and highly collaborative multistakeholder approach to design and implement a streamlined registry protocol with input from all participating US sites. At each design and implementation step, we received input from therapeutic area experts, the US Food and Drug Administration (FDA), the National Institutes of Health, patient and parent advocates, health technology partners, drug developers, and site-based clinical investigators. The registry is governed by a multistakeholder steering committee with representation from sites, industry partners, patient advocates, and a member from the FDA (non-voting with respect to steering committee matters). The multistakeholder and site-driven approach to registry design and execution was highly efficient and resulted in the first patient enrolled within 6 months of concept development.RESULTSWe used an iterative and highly collaborative multistakeholder approach to design and implement a streamlined registry protocol with input from all participating US sites. At each design and implementation step, we received input from therapeutic area experts, the US Food and Drug Administration (FDA), the National Institutes of Health, patient and parent advocates, health technology partners, drug developers, and site-based clinical investigators. The registry is governed by a multistakeholder steering committee with representation from sites, industry partners, patient advocates, and a member from the FDA (non-voting with respect to steering committee matters). The multistakeholder and site-driven approach to registry design and execution was highly efficient and resulted in the first patient enrolled within 6 months of concept development.By ensuring regulatory compliant implementation of the registry, we created both a source of real-world data and a multisite platform for the conduct of future clinical trials that can be submitted to regulatory authorities to support inclusion of pediatric data in approved drug labeling. A highly collaborative approach with broad stakeholder engagement at all stages of the registry development was a key to our operational success.CONCLUSIONSBy ensuring regulatory compliant implementation of the registry, we created both a source of real-world data and a multisite platform for the conduct of future clinical trials that can be submitted to regulatory authorities to support inclusion of pediatric data in approved drug labeling. A highly collaborative approach with broad stakeholder engagement at all stages of the registry development was a key to our operational success. |
| Author | Hornik, Christoph P. Hershey, Andrew Kessel, Shirley Pezzuto, Tara Bickel, Jennifer McHale, Ian Diaz, Coraly Rathore, Geetanjali Patnyiot, Irene Nahouraii, Robert Pownhall, Margie Arun, Deepa Adams, Julia Gelfand, Amy Morgan, Danielle Gladstein, Jack Hagler, Suzanne Saper, Joel Gruber, Monica Alexander, John J. Aikman, Rachel de Prado, Blanca Marquez Ekers, Heather Ross, Judith Saeed, Isra Irwin, Samantha Hirtz, Deborah Thomas, Melissa Brengle, Lisa Szperka, Christina Kutz, Christen Gelfand, Amy A. Kerman, Karen Utevsky, Amanda Roach, Daniel Lee‐Eng, Jacqueline Doll, Elizabeth Guthrie, Cecilia Blume, Heidi Szperka, Christina L. Victorio, Maria (Cris) Cohen‐Wolkowiez, Michael Quintero, Tami Stieglitz, Kimberly Carabello, Dawn Ryan, Erin Boorigie, Madeline McCune, Susan Turley, Christine Ventimiglia, Jodi Benjamin, Daniel K. Chandler, Zachery David Rothner, A |
| AuthorAffiliation | 3 Children’s Hospital of Philadelphia, Pediatric Headache Program, & Department of Neurology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA 6 Office of Pediatric Therapeutics, US Food and Drug Administration, Silver Spring, MD 7 Division of Pediatric and Maternal Health, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 5 Miles for Migraine, Lafayette Hill, PA 1 Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC 2 University of California San Francisco, Child & Adolescent Headache Program, San Francisco, CA 4 Nemours/Alfred I. DuPont Hospital for Children, Nemours Neurology Headache Program, Wilmington, DE |
| AuthorAffiliation_xml | – name: 6 Office of Pediatric Therapeutics, US Food and Drug Administration, Silver Spring, MD – name: 3 Children’s Hospital of Philadelphia, Pediatric Headache Program, & Department of Neurology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA – name: 2 University of California San Francisco, Child & Adolescent Headache Program, San Francisco, CA – name: 1 Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC – name: 5 Miles for Migraine, Lafayette Hill, PA – name: 4 Nemours/Alfred I. DuPont Hospital for Children, Nemours Neurology Headache Program, Wilmington, DE – name: 7 Division of Pediatric and Maternal Health, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/31758549$$D View this record in MEDLINE/PubMed |
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| CitedBy_id | crossref_primary_10_1186_s10194_022_01447_3 crossref_primary_10_1111_head_14315 crossref_primary_10_1055_s_0043_1771175 crossref_primary_10_1016_j_pediatrneurol_2023_05_019 crossref_primary_10_1007_s11910_022_01224_4 crossref_primary_10_1186_s10194_023_01700_3 crossref_primary_10_1080_14737175_2020_1797493 crossref_primary_10_1093_jamia_ocaa224 |
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| Copyright | 2019 American Headache Society 2019 American Headache Society. 2020 American Headache Society |
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To develop a multicenter, multistakeholder, prospective clinical registry of children and adolescents with migraine to support the collection of... To develop a multicenter, multistakeholder, prospective clinical registry of children and adolescents with migraine to support the collection of real-world... ObjectiveTo develop a multicenter, multistakeholder, prospective clinical registry of children and adolescents with migraine to support the collection of... |
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| SubjectTerms | Adolescent Adolescents Biobanks Child Child, Preschool Children clinical registry Clinical trials Collaboration Data capture Databases, Factual Design Female Follow-Up Studies Headache Health Humans Infrastructure Intersectoral Collaboration Male Migraine Migraine Disorders - diagnosis Mobile Applications Neurological diseases Patients Pediatrics Prospective Studies real‐world data Registries Regulatory agencies regulatory submission Scientific visualization Stakeholder Participation Teenagers United States Visualization |
| Title | Development of a Prospective Real‐World Data Clinical Registry of Children and Adolescents With Migraine |
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