Establishing consistency across all regions in a multi-regional clinical trial

In recent years, global collaboration has become a conventional strategy for new drug development. To accelerate the development process and shorten approval time, the design of multi-regional clinical trials (MRCTs) incorporates subjects from many countries/regions around the world under the same protocol. After showing the overall efficacy of a drug in a global trial, one can also simultaneously evaluate the possibility of applying the overall trial results to all regions and subsequently support drug registration in each region. However, most of the recent approaches developed for the design and evaluation of MRCTs focus on establishing criteria to examine whether the overall results from the MRCT can be applied to a specific region. In this paper, we use the consistency criterion of Method 1 from the Japanese Ministry of Health, Labour and Welfare (MHLW) guidance to assess whether the overall results from the MRCT can be applied to all regions. Sample size determination for the MRCT is also provided to take all the consistency criteria from each individual region into account. Numerical examples are given to illustrate applications of the proposed approach.     

Dynamic pricing and revenue management process in Internet retailing under uncertainty: An integrated real options approach

Competition and demand volatility often cause modern enterprises to be confronted by uncertain environments. When a firm manages revenue in such competitive and risky environments, the optimization of pricing and capacity allocation, subject to a fixed time and capacity, becomes a complicated problem. Many previous papers concerning revenue management (RM) and pricing require that the firm possesses the ability to know the demand curve (or demand distribution) and set prices on it to maximize profits. However, this assumption may not be the case in some industries. Therefore, this paper focuses on the dynamic lead indicators rather than assumptive lag indicators to establish a concise and flexible decision model for practical use. This paper provides an integrated real options (IRO) approach with analytic hierarchy process (AHP) for the auction RM problem under competitive/dynamic pricing and revenue uncertainty in Internet retailing. A numerical example is also presented to illustrate that the IRO approach can generate better decisions than the naı¨ve (or risk unawareness) approach in revenue quality of safety and profitability. The new perspective and approach proposed by this paper can be extended to other RM fields whenever both profitability and risk are critical to decision making.     

The Impacts of Acculturative Stress and Social Competence on the Mental Health of Mainland Chinese Immigrant Youth in Hong Kong

Correspondence to Dr Daniel Fu Keung Wong, Associate Professor in the Department of Social Work and Social Adminstration, 1317 K K Leung Building, The University of Hong Kong, Pokfulam Road, Hong Kong.E-mail: dfkwong{at}hkucc.hku.hk Summary Attempts were made to examine migration stressors, social competence,and mental health status of immigrant youth in Hong Kong andto examine the effects of social competence on stress and themental health of immigrant youth. Data on 106 immigrant youth,which were collected through a structured questionnaire, wereanalysed. It was discovered that immigrant youth found survivalissues and losses, rather than cultural differences and unfulfilledexpectations, to be stressful. Male immigrant youth exhibitedmore psychological distress symptoms than female immigrant youth.Hierarchical regression analyses revealed that social competenceexerted moderating effects on stress and the mental health ofimmigrant youth. Immigrant youth who had a higher level of socialcompetence, in terms of self-control, empathy, assertivenessand the ability to read social cues, had less stress and enjoyedbetter mental health. In conclusion, personal and socio-culturalreasons are put forward to explain the findings. Practice andpolicy implications are also discussed.     

Quality of Life in Older Adults: Benefits from Caring Services in Hong Kong

Many older adults are in need of care. Therefore, older people would generally benefit from the use of caring services, notably including home care, residential care, nursing, and medical services. The contributory factors underlying caring services tend to be a caring perspective that aspires to sustain older people’s social relationships and real-life involvement. To gauge the benefits from various social and health services, the present study relies on a large-scale survey of 3000 older adults in Hong Kong, using quality of life as a criterion. Results showed that an older adult who had used (ordinary or enhanced) home care services for a longer time turned out to have appreciably more improvement in quality of life. Besides, those who joined an interest group more frequently were higher in quality of life, including the health domain. On the other hand, frequent use of medical and meal-to-home services were signals that reflected problems detrimental to the older user’s quality of life. Despite this, the quality of clinics or hospitals, as perceived by the older adult, was the most beneficial. As such, caring services that foster older adults’ interests, cater to their health care needs, and embody quality can have principal contribution to their users’ quality of life.     

Orientalist Knowledge and Social Theories: China and the European Conceptions of East‐West Differences from 1600 to 1900

This paper examines the long‐term development of Orientalism as an intellectual field, with the European learning of China between ca.1600 and ca.1900 as an exemplary case. My analysis will be aided by a theoretical framework based on a synthesis of the world‐system and network perspectives on long‐run intellectual change. Analyzing recurrent debates on China within European intellectual circles, I demonstrate that the Western conception of the East has been oscillating between universalism and particularism, and between naive idealization and racist bias. This oscillation is a function as much of the changing political economy of the capitalist world‐system as of the endogenous politics of the intellectual field. Despite their contrasting views, both admirers and despisers of the East viewed non‐Western civilizations as uniform wholes that had never changed. I argue that the fundamental fallacy of Orientalism lay, not in its presumptions about the ontological differences between East and West and the former's inferiority, as previous critics of Orientalism have supposed, but in its reductionism. Understanding non‐Western civilizations in their full dynamism and heterogeneity is a critical step toward the renewal of the twentieth‐century social theories that were built upon and impaired by the Orientalist knowledge accumulated in the previous centuries.     

Politics and Productivity

We use a stochastic frontier approach to study the effects of political and regulatory institutions on aggregate productivity in 39 countries from 1975 to 1990. We show that technical efficiency is positively related to policies supporting laissez-faire and political structures that promote policy stability. Moreover, models of technical efficiency incorporating both measures perform better than models including only one or the other. This suggests that economic performance depends not only on current policies but also on the confidence of market participants and outside investors that these policies will remain in place.     

On cubic 2-independent Hamiltonian connected graphs

A graph G=(V,E) is Hamiltonian connected if there exists a Hamiltonian path between any two vertices in G. Let P ₁=(u ₁,u ₂,…,u _|V|) and P ₂=(v ₁,v ₂,…,v _|V|) be any two Hamiltonian paths of G. We say that P ₁ and P ₂ are independent if u ₁=v ₁,u _|V|=v _|V|, and u _i ≠v _i for 1<i<|V|. A cubic graph G is 2-independent Hamiltonian connected if there are two independent Hamiltonian paths between any two different vertices of G. A graph G is 1-Hamiltonian if G−F is Hamiltonian for any F⊆V∪E with |F|=1. A graph G is super 3^*-connected if there exist i internal disjoint paths spanning G for i=1,2,3. It is proved that every super 3^*-connected graph is 1-Hamiltonian. In this paper, we prove that every cubic 2-independent Hamiltonian connected graph is also 1-Hamiltonian. We present some cubic 2-independent Hamiltonian connected graphs that are super 3^*-connected, some cubic 2-independent Hamiltonian connected graphs that are not super 3^*-connected, some super 3^*-connected graphs that are not 2-independent Hamiltonian connected, and some cubic 1-Hamiltonian graphs that are Hamiltonian connected but neither 2-independent Hamiltonian connected nor super 3^*-connected. Dedicated to Professor Frank K. Hwang on the occasion of his 65th birthday. This work was supported in part by the National Science Council of the Republic of China under Contract NSC 94-2213-E-233-011.     

Practices and challenges in educational program evaluation in the Asia-Pacific region: results of a Delphi study

While educational program evaluation has become more important in recent years because of increasing governmental demands for accountability, little is known about the development of and issues in regard to this topic in the Asia-Pacific region. The findings from a Delphi study conducted in a number of relevant countries are provided in this article. Thirty panelists participated in three rounds of iterations to identify current status, challenges, and concerns in the near future. The results should be of value to educational evaluators, researchers, and decision makers.     

Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset

With the advances in human genomic/genetic studies, the clinical trial community gradually recognizes that phenotypically homogeneous patients may be heterogeneous at the genomic level. The genomic technology brings a possible avenue for developing a genomic (composite) biomarker to predict a genomically responsive patient subset that may have a (much) higher likelihood of benefiting from a treatment. Randomized controlled trial is the mainstay to provide scientifically convincing evidence of a purported effect a new treatment may demonstrate. In conventional clinical trials, the primary clinical hypothesis pertains to the therapeutic effect in all patients who are eligible for the study defined by the primary efficacy endpoint. The aspect of one-size-fits-all surrounding the conventional design has been challenged, particularly when the diseases may be heterogeneous due to observable clinical characteristics and/or unobservable underlying the genomic characteristics. Extension from the conventional single population design objective to an objective that encompasses two possible patient populations will allow more informative evaluation in the patients having different degrees of responsiveness to medication. Building in conventional clinical trials, an additional genomic objective can generate an appealing conceptual framework from the patient's perspective in addressing personalized medicine in well-controlled clinical trials. There are many perceived benefits of personalized medicine that are based on the notion of being genomically proactive in the identification of disease and prevention of disease or recurrence. In this paper, we show that an adaptive design approach can be constructed to study a clinical hypothesis of overall treatment effect and a hypothesis of treatment effect in a genomic subset more efficiently than the conventional non-adaptive approach.     

Comparative assessment of gridded population data sets for complex topography: a study of Southwest China

Population and Environment - Population estimates for high-resolution spatial grid cells data can reflect detailed spatial distribution of population, which are valuable for epidemiological...