The rheumatoid arthritis (RA) clinical trial space is very competitive, and recruiting and retaining subjects is of critical importance. Feasibility studies are a central component of ensuring successful recruitment and retention. A feasibility study is an assessment of the practicality of a proposed study protocol, with the goal of understanding challenges and providing risk mitigation strategies leading to better subject enrolment and study start-up should the assessment be favorable. This paper presents findings from a retrospective case series of RA feasibilities, describing important parameters to consider in the highly competitive RA space in Asia. Key parameters identified and discussed are how decisions on clinical development strategy necessitate changes in the clinical operational delivery strategy, with focus on changes in inclusion and exclusion criteria and patient contribution load; how small the patient population becomes when the clinical trial needs to target the patient population that is refractory to standard therapy; regulatory timelines; and the competitive clinical trial landscape. Feasibility assessments are a snapshot in time exercise. Multiple parameters change over time, and, particularly in a space that has become competitive for subjects, one cannot rely on one static feasibility assessment to predict trial performance accurately. Continuous feasibility assessment will also provide insight into the resourcing needs on the part of the sponsor, contract research organization, and investigative site.

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.

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This is a cross-sectional survey conducted from January to March 2014. A validated survey questionnaire was distributed among physician-members of the American Association of Clinical Endocrinologists-Philippine Chapter, Diabetes Philippines, Philippine Society of Endocrinology and Metabolism and Philippine Society of Pediatric Metabolism & Endocrinology. The survey questionnaire was reviewed for content by a team of Quintiles' representatives with expertise in clinical study feasibility, pediatric