Statistical modeling for Bayesian extrapolation of adult clinical trial information in pediatric drug evaluation

Children represent a large underserved population of “therapeutic orphans,” as an estimated 80% of children are treated off‐label. However, pediatric drug development often faces substantial challenges, including economic, logistical, technical, and ethical barriers, among others. Among many efforts trying to remove these barriers, increased recent attention has been paid to extrapolation; that is, the leveraging of available data from adults or older age groups to draw conclusions for the pediatric population. The Bayesian statistical paradigm is natural in this setting, as it permits the combining (or “borrowing”) of information across disparate sources, such as the adult and pediatric data. In this paper, authored by the pediatric subteam of the Drug Information Association Bayesian Scientific Working Group and Adaptive Design Working Group, we develop, illustrate, and provide suggestions on Bayesian statistical methods that could be used to design improved pediatric development programs that use all available information in the most efficient manner. A variety of relevant Bayesian approaches are described, several of which are illustrated through 2 case studies: extrapolating adult efficacy data to expand the labeling for Remicade to include pediatric ulcerative colitis and extrapolating adult exposure‐response information for antiepileptic drugs to pediatrics.     

The role of tourism in national human resource development: a Jamaican perspective

Research in the national human resource development (NHRD) field is increasingly considering unique cultural and economic conditions and the influence this may have on a number of employment-related indicators. To date, the NHRD literature has largely ignored issues related to skills training and workforce development in the tourism industry, despite the expanding nature of this dynamic service sector in many nations. This literature review study of NHRD in Jamaica examined ongoing national-level human resource development (HRD) initiatives with specific attention to the current and future impact of NHRD on the tourism industry. The results showed that governmental development plans clearly identified tourism as a key sector for economic growth to support larger economic and social development goals. Furthermore, the development of human resources in the tourism sector was seen as being of vital importance for tourism organizations and for the continued development of Jamaica. The existing NHRD literature has largely overlooked the potential influence and future role of the tourism industry to assist in education, training and development goals at the national level. Recommendations are made for additional research exploring connections between NHRD and tourism employment.     

Repurposing Materials and Waste through Online Exchanges: Overcoming the Last Hurdle

Online material and waste exchanges (OMWEs) provide online channels to repurpose by‐products, unused materials and waste from industrial and commercial facilities. Unfortunately, OMWE's also have challenges. First, sellers may have access to other disposal options and, as a result, may not fully commit to the exchange. Second, buyers can face high uncertainty about the product exchanged and the transaction being undertaken. Overcoming these challenges is the “last hurdle” to making OMWEs successful. This study investigates the factors that reduce the buyers' uncertainty and increase the sellers' commitment to the OMWE. We analyze novel transaction‐level data from an online exchange (MNExchange.org) combined with other archival public records on county‐level repurposing and disposal statistics. First, we find that regional repurposing policies and alternatives have a complementary effect on sellers' commitment toward OMWEs, resulting in increased OMWE exchanges. However, regional disposal policies and alternatives have a substitution effect on sellers' commitment, resulting in reduced exchange success. Further, greater product and transaction information reduce the buyer's uncertainty and increase exchange success. Finally, the analysis shows that users' (buyers and sellers) heavily rely on their prior experience with OMWEs. Specifically, higher familiarity between the buyer–seller pair and familiarity with the OMWE system leads to higher likelihood of exchange success. This study lays the foundation for understanding OMWEs and has important implications for developing policies and operations to increase online transactions of by‐products, materials and wastes.