High quality clinical trial research in child health is needed in order to provide children with safe and effective treatments. Unfortunately, recent reviews show that trials in child health lack validity and precision, and therefore fail to inform decision making at the bedside and system level. Clinical research in child health is, in some respects, more challenging than research involving adults. These challenges include relatively small numbers of children with serious medical problems, the need for developmentally appropriate outcome measures for children of different ages, the complexities of parental involvement and obtaining consent, and the adaptations required in research procedures and settings to accommodate children's physical, cognitive, and emotional development.
New insights in efficient trial design are needed for implementation in child health to overcome some of these challenges and prevent research “waste” from occurring. The effectiveness of clinical trial design can be improved by adopting a more integrated approach that increases flexibility and maximizes the use of accumulated knowledge. The Enhancing Research in International Child Health (EnRICH) group (http://www.sickkids.ca/Research/EnRICH/index.html) adopts this unified approach and aims to enhance child health through the development of evidence, tools and training opportunities. These initiatives seek to improve the quality of design, conduct, and reporting of pediatric clinical research.
This three day intermediate-level course takes an integrative approach to trial design by teaching a conceptual framework that includes outcome selection and measurement, value of information, cost effectiveness, risk of bias, and choice of comparators. Mastery of these concepts enables students to prepare winning child health grant proposals in the face of uncertainty. Each day will include a mix of plenary sessions, group discussion, breakout sessions, and computer-based tutorials. The course will also feature an interactive half-day session for consultation where attendees can discuss their clinical trial design questions with leading methodologists in child health.
Wednesday, May 21, 2014 - Friday, May 23, 2014 8:15 AM - 5:00 PMEastern Time Zone
Peter Gilgan Centre for Research & LearningThe Hospital for Sick Children686 Bay StreetToronto, Ontario M5G 0A4Canada
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