Pediatric Clinical Trials: Current Scenario in the Asia Pacific Region

Abstract

Lisa Marie Saldanha,1 Saumya Nayak,1 Adeline Sng,1 Mei-Ling Long,1 Elisabeth Schrader,2 Amanur Rahman,3 Elvira Zenaida Lansang,1 Karen Wai,1 Ken Lee41Feasibility and Site Identification Asia, Quintiles East Asia Private Limited, Singapore; 2Quintiles Pediatric Center of Excellence, Durham, NC, USA; 3Faculty of Engineering, National University of Singapore, Singapore; 4Asia Site Services, Quintiles East Asia Private Limited, SingaporeObjective: This site survey was conducted to understand the current pediatric clinical trial landscape across countries in the Asia Pacific region, specifically in terms of interest, experience, capabilities, requirements of the ethics committee, patient availability, and overall challenges involved in conducting pediatric trials.Methods and materials: Between May and June 2012, an English language survey form was sent to sites (identified through Quintiles’ internal database) with pediatric capability and referrals from doctors during a preliminary outreach. In July 2012, the responses from the completed survey forms were entered into SurveyMethods, a web-based central repository. Data analysis was performed in August–September 2012 using SurveyMethods.Results: Seventy-seven sites were contacted for this survey across the Asia Pacific region. Sixty-four percent (49 sites) completed 63 surveys and confirmed interest to participate in clinical trials in the pediatric population. Seventy-one percent of the sites had prior experience. Eighty percent confirmed needing an assent from pediatric patients; 81%–95% confirmed acceptance of placebo-controlled and pharmacokinetic studies by ethics committees; and 37% cited challenges in conducting studies in this population.Conclusion: This survey indicates that there is a high level of interest among sites in the Asia Pacific region in conducting pediatric trials across various therapeutic indications. No major insurmountable challenges were identified in conducting pediatric trials. Complexity of the consent and assent process across the countries needs to be considered. Also to be considered are the sites’ needs as well as trial design adaptations for this population to ensure compliance (minimize invasive procedures, placebo control, visit schedules versus school timings, etc). There also appears to be an adequate patient pool in many indications, and the availability of a database of healthy subjects can assist in faster screening of subjects for vaccine trials.Keywords: Site survey, ethical, challenges, consent patients