Inflammatory bowel disease (IBD) – primarily Crohn’s disease and ulcerative colitis – is a debilitating lifelong condition with significant health and economic costs. From diagnosis to management, IBD can cause huge psychosocial concerns to patients and their caregivers. This study reports an experience of a Crohn’s patient, leading to the formation of the first IBD patient support group in Singapore and how this group has evolved in the last 4 years in supporting other IBD patients. IBD patient advocacy and/or support groups facilitate open conversations on patients’ fears, concerns, preferences and needs, and may potentially improve disease knowledge and quality of life for individuals with the condition or their families.

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.

Introduction:Conducting clinical trial feasibility is an important first step in initiating a clinical trial. A robust feasibility process ensures that a realistic capability assessment is made before conducting a trial. A retrospective analysis of vaccine clinical trials was performed to understand changes which could affect feasibility recommendations. Methods: Feasibilities conducted by Quintiles between January 2011 and August 2012 were reviewed. Vaccine studies only involving Asia-Pacific countries were selected, and common study parameters were identified. Information from Quintiles' database was retrieved to examine changes in parameters over time. Results: A total of six vaccine studies were identified within the 1.7-year period. Two studies were excluded because they did not contain feasibility information or had involved sites that were sponsor selected. Four studies were analyzed. Three cases required healthy volunteers, while one case involved a specific patient population. Age requirement and seasonality of disease mainly influenced recommendations for Study 1. Sponsor's marketing strategy influenced the recommendations for Study 2. Study 3 showed the effect of a country's immunization program and reimbursement of vaccines on a study's success. In contrast to the other studies, Study 4 demonstrated the impact of eligibility criteria in recruitment recommendations for a vaccine trial requiring specific patient pools. Conclusion: Feasibility recommendations for vaccine trials are largely based on (1) eligibility criteria; (2) cultural beliefs; (3) country's past recruitment performance; (4) use of advertising; (5) site's access to subject populations; (6) cooperation with local health professionals and government; (7) sponsor's marketing strategies; (8) study design concordance with national immunization programs; (9) reimbursement of vaccines; (10) overall benefit of the vaccine to the population; and where applicable, (11) seasonality of the disease under study.

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.