Kathryn Blake1, Janet T Holbrook2, Holly Antal3, David Shade4, H Timothy Bunnell5, Suzanne M McCahan6, Robert A Wise7, Chris Pennington8, Paul Garfinkel9, Tim Wysocki10. 1. Center for Pharmacogenomics and Translational Research, Nemours Children's Specialty Care, 807 Children's Way, Jacksonville, FL 32207, USA. Electronic address: kathryn.blake@nemours.org. 2. Center for Clinical Trials and Evidence Synthesis, Johns Hopkins University, 415 N Washington Street, Baltimore, MD 21205, USA. Electronic address: janet.holbrook@jhu.edu. 3. Division of Psychiatry and Psychology, Nemours Children's Specialty Care, 807 Children's Way, Jacksonville, FL 32207, USA. Electronic address: holly.antal@nemours.org. 4. Center for Clinical Trials and Evidence Synthesis, Johns Hopkins University, 415 N Washington Street, Baltimore, MD 21205, USA. Electronic address: dshade1@jhu.edu. 5. Bioinformatics Core Facility, Nemours/Alfred I. duPont Hospital for Children, 1600 Rockland Road, Wilmington, DE 19803, USA. Electronic address: tim.bunnell@nemours.org. 6. Bioinformatics Core Facility, Nemours/Alfred I. duPont Hospital for Children, 1600 Rockland Road, Wilmington, DE 19803, USA. Electronic address: Suzanne.mccahan@nemours.org. 7. Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA. Electronic address: rwise@jhmi.edu. 8. Bioinformatics Core Facility, Nemours/Alfred I. duPont Hospital for Children, 1600 Rockland Road, Wilmington, DE 19803, USA. Electronic address: chris.pennington@nemours.org. 9. Nemours Office of Human Subjects Protection, Nemours Foundation, 10140 Centurion Parkway North, Jacksonville, FL 32256, USA. Electronic address: paul.garfinkel@nemours.org. 10. Center for Health Care Delivery Science, Nemours Children's Specialty Care, 807 Children's Way, Jacksonville, FL 32207, USA. Electronic address: tim.wysocki@nemours.org.
Abstract
INTRODUCTION: Phase III/IV clinical trials are expensive and time consuming and often suffer from poor enrollment and retention rates. Pediatric trials are particularly difficult because scheduling around the parent, participant and potentially other sibling schedules can be burdensome. We are evaluating using the internet and mobile devices to conduct the consent process and study visits in a streamlined pediatric asthma trial. Our hypothesis is that these study processes will be non-inferior and will be less expensive compared to a traditional pediatric asthma trial. MATERIALS/ METHODS: Parents and participants, aged 12 through 17 years, complete the informed consent process by viewing a multi-media website containing a consent video and study material in the streamlined trial. Participants are provided an iPad with WiFi and EasyOne spirometer for use during FaceTime visits and online twice daily symptom reporting during an 8-week run-in followed by a 12-week study period. Outcomes are compared with participants completing a similarly designed traditional trial comparing the same treatments within the same pediatric health-system. After 8 weeks of open-label Advair 250/50 twice daily, participants in both trial types are randomized to Advair 250/50, Flovent 250, or Advair 100/50 given 1 inhalation twice daily. Study staff track time spent to determine study costs. RESULTS: Participants have been enrolled in the streamlined and traditional trials and recruitment is ongoing. CONCLUSIONS: This project will provide important information on both clinical and economic outcomes for a novel method of conducting clinical trials. The results will be broadly applicable to trials of other diseases.
RCT Entities:
INTRODUCTION: Phase III/IV clinical trials are expensive and time consuming and often suffer from poor enrollment and retention rates. Pediatric trials are particularly difficult because scheduling around the parent, participant and potentially other sibling schedules can be burdensome. We are evaluating using the internet and mobile devices to conduct the consent process and study visits in a streamlined pediatric asthma trial. Our hypothesis is that these study processes will be non-inferior and will be less expensive compared to a traditional pediatric asthma trial. MATERIALS/ METHODS: Parents and participants, aged 12 through 17 years, complete the informed consent process by viewing a multi-media website containing a consent video and study material in the streamlined trial. Participants are provided an iPad with WiFi and EasyOne spirometer for use during FaceTime visits and online twice daily symptom reporting during an 8-week run-in followed by a 12-week study period. Outcomes are compared with participants completing a similarly designed traditional trial comparing the same treatments within the same pediatric health-system. After 8 weeks of open-label Advair 250/50 twice daily, participants in both trial types are randomized to Advair 250/50, Flovent 250, or Advair 100/50 given 1 inhalation twice daily. Study staff track time spent to determine study costs. RESULTS:Participants have been enrolled in the streamlined and traditional trials and recruitment is ongoing. CONCLUSIONS: This project will provide important information on both clinical and economic outcomes for a novel method of conducting clinical trials. The results will be broadly applicable to trials of other diseases.
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