Growing risk avoidance in Asian oncology site selection: how trends in site selection are limiting growth of the Asia cancer trial landscape

Abstract

David Horsburgh,1 Yi-Chen Josey Lee,2 Elvira Zenaida Lansang,1 Ken J Lee,3 Malcolm Ogg,4 Karen Wai1 1Feasibility and Site Identification Asia, Quintiles East Asia Pte Ltd, Singapore; 2Feasibility and Site Identification Asia, Quintiles East Asia Pte Ltd, Taipei, Taiwan; 3Site Services Asia, Quintiles East Asia Pte Ltd, Singapore; 4Global Integrated Site Services, Quintiles, Green Park, Reading, Berkshire, United Kingdom Background: Asia-Pacific represents the fastest-growing region for clinical trials, with growth in oncology studies being a strong contributor. Such demand has seen a rapid change in Asia's total site pool and the number of experienced and inexperienced, or naïve, sites being activated. Given the perceived risks involved with naïve sites, this study aims to investigate changes in the rate of naïve site selection and how this risk management may influence future growth within the region. Methods: Rates of total naïve and experienced sites initiated per year, per protocol, and the relative contribution of each to the yearly site total were analyzed. Data was collected from Quintiles internal metrics as well as from the publicly available ClinicalTrials.gov database and was filtered to include oncology studies involving at least one Asian country, between the years 2000 and 2012. Results and discussion: Despite a general increase in the number of sites activated overall, the contribution of naïve sites to the yearly total fell to 20% in 2012. Experienced sites were heavily favored, with reliance on the existing site network preferred to expansion through naïve sites. This is likely a result of the perceived challenges with using inexperienced sites and the industry desire to avoid this risk. However, fluctuations in naïve sites activation suggest that the limited level of growth in the site pool may not be enough to sustain demand, with sudden outreaches to naïve sites necessary as current site pool capacity is occasionally reached. This may cause a sudden period of high risk converse to the initial risk-avoidance strategy. On the basis of this analysis we propose an alternative site selection policy of steady site pool expansion through naïve site activation, combined with risk management policies. This constant managed-risk method could allow for greater prediction of site challenges and could provide the necessary site network as Asia continues to increase its contribution to the global clinical trial landscape. Keywords: site, naïve, experienced, inexperienced, capacity, risk, site contribution, trend, growth, sustainable, oncology, landscape