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PubMedDate not supplied

Ethnic variations of a retinoblastoma susceptibility gene (RB1) polymorphism in eight Asian populations.

An A --> G single nucleotide polymorphism (SNP) at nucleotide 153,104 in the retinoblastoma susceptibility locus (RB1) at 13q14 was previously reported to be present only in Asians. In this study, we determined the distribution of this SNP in normal Southeast Asian populations (Chinese, Malay, Javanese, Thai, Filipino), in South Asian populations (Bangladeshi, Pakistani Pushtun and Indian) and in Chinese retinoblastoma cases and control subjects. The RB1 SNP was present in all populations at an overall frequency of =/< 0.18. Heterozygosity was higher in the Southeast Asian groups (0.14-0.34) than in the South Asian groups (Bangladeshi and Indian) (0.04-0.06). Significant differences in allele frequencies were found between the two population groups. Interestingly, our Pakistani population comprised of ethnic Pushtuns from northwest Pakistan was significantly different from the neighbouring Bangladeshi and Indian populations. No significant difference was found between Chinese case patients and control subjects. This RB1 SNP appears to be an ethnic variant prevalent in Southeast Asian populations and may be useful for studying RB1 inheritance by pedigree analysis.

Asia↗
PubMed1999

Relation of triglyceride stores in skeletal muscle cells to central obesity and insulin sensitivity in European and South Asian men.

AIMS/HYPOTHESIS: To compare the relation between intramyocellular lipid content, central obesity and insulin sensitivity in Europeans and South Asians. METHODS: Cross-sectional study of 40 South Asian and European non-diabetic men matched for age and body mass index. We measured intramyocellular lipid by proton magnetic resonance spectroscopy of soleus muscle, insulin sensitivity by the short insulin tolerance test, per cent body fat by dual-energy x-ray absorptiometry and visceral fat by single-slice computed tomography of the abdomen. RESULTS: South Asians compared with Europeans had a higher mean per cent body fat (26.8% vs 22.5%, p = 0.05) and lower insulin sensitivity (mean +/- SEM 2.4 +/- 0.2 vs 3.4%/min +/- 0.3, p = 0.013). Mean (+/- SEM) intramyocellular lipid content was higher in South Asians than in Europeans (72.1 +/- 7.5 vs 53.6 +/- 4.9 mmol/kg dry weight, p = 0.046). In Europeans intramyocellular lipid was correlated with per cent body fat (r = 0.50, p = 0.028), waist:hip ratio (r = 0.74, p < 0.001), visceral fat (r = 0.62, p = 0.004) and insulin sensitivity (r = -0.53, p = 0.016). In South Asians intramyocellular lipid was not significantly related to insulin sensitivity or obesity, and the strongest associations of insulin sensitivity were with fasting plasma triglyceride and waist:hip ratio. CONCLUSION/INTERPRETATION: The association of intramyocellular lipid with insulin sensitivity and obesity in Europeans is consistent with the hypothesis that muscle triglyceride mediates the effect of obesity on insulin sensitivity. The absence of a similar relation of insulin sensitivity to intramyocellular lipid in South Asians suggests that other mechanisms underlie the high insulin resistance observed in this group.

Absorptiometry, Photon↗
PubMed2004

Care pathways for south Asian and white people with depressive and anxiety disorders in the community.

BACKGROUND: South Asian people with common mental disorders are less likely to have their problems recognised by their general practitioner and have lower rates of uptake of psychiatric services compared to native born white people. Less consideration has been given to their understanding of their mental health problems, their use of alternative supports and the treatment they receive in primary care. METHODS: A general population sample identified, using a semi-structured diagnostic interview, as having DSM-IIIR depressive or anxiety disorders was obtained. South Asian and white participants' appraisal of their mental health problems and their use of informal and formal assistance during the period they were unwell in the previous 6 months were compared. RESULTS: There was no difference between south Asian and white people, either in what they understood to be the matter with them or in what they perceived to be the cause of their problems. No south Asian participants reported seeking help from lay or traditional healers, while white people more often discussed their problems with a relative or friend. Most south Asian people consulted their GP and this was significantly higher than for whites. However, only around half the people in both groups reported disclosing their problem to a GP and only one in ten received psychiatric medication or was referred to specialist psychiatric services. CONCLUSIONS: Along with public education and GP training, the availability of appropriate and acceptable interventions for south Asian, and indeed white people, with common mental disorders consulting in primary care is key to ensuring that they gain access to necessary mental health care.

Adolescent↗
PubMed2002

A public forum to promote organ donation amongst Asians: the Scottish initiative.

There is a chronic shortage of organs for transplantation in the UK. This problem is particularly acute amongst Asians living within the UK. The Transplant Unit, University of Glasgow, joined forces with local businessmen to initiate a public meeting to promote awareness of transplant issues affecting Asians in the greater Glasgow area. During the Forum, we conducted a survey to determine the level of knowledge about organ transplantation, donation and willingness to donate, in relationship to the age, gender, marital status and religious affiliation amongst the attendees. The Forum was conducted at a public hall after publicity in the local press and Asian shops. The meeting was attended by over 300 people of Asian origin. Of the 90 survey forms handed out, 80 were returned fully completed. There was almost no opposition to organ donation, and many of the respondents were aware that religious leaders in the UK had endorsed organ donation. However, favourable disposition to these issues was not accompanied by carrying of the organ donor card, despite an awareness of the National Donor Register. The majority of the respondents were willing to undergo live organ donation, but were undecided about cadaveric donation. The issue of presumed consent drew mixed responses. Asians in the Glasgow region are not sympathetic to the matter of organ transplantation and donation, despite their recognition of the issues of organ shortage. We suggest that the matter needs to be further integrated into Asian culture by religious leaders and business persons. Our findings indicate that women over the age of 30 and based in the home may be in a unique position of influence by virtue of their position of centrality within the social network. This approach may also be suitable in other areas of the UK and the world with a large number of ethnic minorities.

Adult↗
PubMed1999

Awareness and attitudes towards organ donation and transplantation among the asian population. A preliminary survey in Luton, UK.

Currently the demand for transplant organs, particularly kidneys, far outstrips the supply in the UK. This problem is particularly severe for the Asian population, which has been shown to have a disproportionately large representation on kidney-transplant waiting lists in some regions of the UK. The situation is clear: there is an urgent need to address the number of Asians requiring a kidney transplant, otherwise the human and economic costs will be very high. An exploratory qualitative study was therefore undertaken with the aim of assessing current awareness of organ donation and transplantation and to explore attitudes towards these issues in a cross section of the Asian population in Luton. It was found that nearly half of the respondents in this survey did not know what a donor card was used for, and approximately half of these had never seen one; only 6 of the 64 people interviewed had heard of the National Donor Register. Of the three people who carried a donor card, two had an immediate family member who had received a transplant. This suggests that media campaigns aimed at attracting donors from the Asian population have had limited success thus far. It appears that the vast majority of the Asian population is at the initial stage of the process of making a decision about donating their organs, that of simply knowing that transplantation takes place. Very little debate of pertinent issues seems to have taken place, which is essential for reaching a decision on whether or not to donate an organ. The study should be seen as exploratory but is nonetheless an important initial step towards the establishment of a greater knowledge and understanding of the issues affecting the low donation rate in the Asian population.

Asia↗
PubMed2004

Validation of a food frequency questionnaire to assess macro- and micro-nutrient intake among South Asians in the United Kingdom.

BACKGROUND: The South Asian population is one of the largest minority ethnic groups in the United Kingdom (UK), forming 2.7% of the UK population. Risk of diseases such as CHD, NIDDM is high in South Asians and risk of cancer low in this population compared both to the native UK population and other migrant groups. It is useful to investigate the experience of disease and dietary exposures for aetiological clues in South Asians. The FFQ was designed for a population-based case-control study of diet and breast cancer. AIMS: To validate a food frequency questionnaire (FFQ) to assess macro- and micronutrient intake among South Asians in the United Kingdom (UK). METHODS: A one-year long study of current diet was conducted using monthly telephone 24-hour recalls followed by administration of an interviewer-administered FFQ to ascertain usual diet during this period. General practices in the Thames and West Midlands regions, England were used to sequentially recruit 100 women from a larger random sample of South Asian migrants from general practitioners' patient lists participating as controls in a case-control study of diet and breast cancer. RESULTS: A total of 133 women were invited to achieve the final sample of 100 (76% response rate). The proportion of individuals classified by the two dietary assessment methods into the same or adjacent quartiles was high ranging from 65% (vitamin A) to 96% (protein). Misclassification into opposite quartiles was very low (0 % to 5 %), except for vitamin A (10 %). Energy-adjusted Spearman correlation coefficients were reasonable for almost all nutrients being highest for protein (0.76), NSP (0.71), folate (0.70) and cholesterol (0.69). Correction for within-person variation in monthly 24-hour recalls had little effect on the magnitude of the nutrient correlations between the FFQ and the 24-hour recalls. Calibration coefficients to correct relative risks for nutrient-disease associations were above 0.50 for most nutrients indicating that the degree of attenuation introduced by the FFQ would be acceptable. CONCLUSIONS: This FFQ was specifically designed for South Asian women in the UK. Despite the diversity of diets, the FFQ had reasonable validity. The role of diet in breast cancer disease aetiology in this population is being assessed with this instrument.

Adult↗
PubMed1994

Interactions between infant care practices and physiological development in Asian infants.

Asian infants are less likely to suffer cot death despite apparently higher prevalence of some risk factors. This paper compares the development of night time body temperature patterns in a small sample of Asian babies with the pattern already established for white infants, where babies who develop an adult-like night time temperature pattern later than usual share characteristics with victims of SIDS. The Asian infants had similar body temperature patterns to whites, but tended to develop the adult-like pattern later, not earlier as might have been expected. More Asian infants than white in our sample slept in the parental bed, and, before the adult-like body temperature patterns appeared, co-sleeping infants had higher body temperatures than those in their own cots. Asian infants slept in significantly warmer rooms than whites, but under similar amounts of bedding. These studies do not therefore reveal any physiological difference between Asians and whites which might account for low vulnerability to cot death, indeed, if anything the reverse.

Adult↗
PubMed1994

Sex and ethnic group differences in fat distribution in young United Kingdom South Asians and Europids.

South Asians (Asians) have a high prevalence of non-insulin-dependent diabetes (NIDDM) and a high incidence of ischaemic heart disease (IHD). To investigate whether this predisposition can be detected in young adult life, metabolic risk factors for these diseases were compared in U.K. Europid and Asian students. Among the 80 Europid and 80 Asian students aged between 20 and 23 years and well matched for body mass index (BMI), Asians were found to be relatively hyperglycaemic [5.1 (5.0-5.2) vs 4.6 (95% CI: 4.5-4.7) mmol/l] and hypercholesterolaemic [5.3(5.2-5.4) vs 4.9 (4.8-5.0) mmol/l] and to have a higher waist/hip and subscapular/triceps ratio. The waist/hip ratio was found to be a better predictor of glucose and cholesterol than calliper measurements in both ethnic groups although the subscapular/triceps ratio was independently related to both glucose and cholesterol. Predictors of both IHD and NIDDM are present at an early age in U.K. Asians.

Adipose Tissue↗
PubMed2004

Understanding mental health needs of Southeast Asian refugees: historical, cultural, and contextual challenges.

Research and clinical information pertaining to mental health needs of Asians residing in the United States is limited but growing. There is a tendency to group all persons of Asian descent together and, therefore, the empirical literature does not sufficiently address the mental health needs in specific subgroups. The focus of this article is to understand the mental health needs of one subgroup of Asians--Southeast Asian refugees (SEAR). The main purpose is to review the relevant literature pertaining to Southeast Asian refugees' experiences and to understand the manifestation of psychiatric disorders by examining historical, cultural, and contextual challenges. Despite the well-documented mental health needs for SEAR, most do not present for mental health services. Therefore, resilience and protective factors are discussed. Research and clinical implications are described and suggestions are offered on how to apply information obtained from Southeast Asian refugees' experiences to future refugees.

Asia, Southeastern↗
PubMed2005

Derivation and validation of diabetes risk score for urban Asian Indians.

OBJECTIVE: Simple risk scores for identifying people with undiagnosed diabetes have been developed, mostly in Caucasian groups. This may not be suitable for Asian Indians, therefore this study was undertaken to develop and validate a simple diabetes risk score in an urban Asian Indian population with a high prevalence of diabetes. We also tested whether this score was applicable to South Asian migrants living in a different cultural context. RESEARCH DESIGN AND METHODS: A population based Cohort of 10,003 participants aged >or=20 years was divided into two equal halves (Cohorts 1 and 2), after excluding people with known diabetes. Cohort 1 (n=4993) was used to derive the risk score. Validation of the score was performed in the other half of the survey population (Cohort 2) (n=5010). The validation was also done in a separate survey population in Chennai, India (Cohort 3) (n=2002) (diagnosis of diabetes was based on OGTT) and in the South Asian Cohort of the 1999 Health Survey for England (n=676) (fasting glucose value>or=7 mmol/l and HbA1c>or=6.5% were used for diagnosis). A logistic regression model was used to compute the beta coefficients for risk factors. The risk score value was derived from a receiver operating characteristic curve. RESULTS: The significant risk factors included in the risk score were age, BMI, waist circumference, family history of diabetes and sedentary physical activity. A risk score value of >21 gave a sensitivity, specificity, positive predictive value and negative predictive value of 76.6%, 59.9%, 9.4% and 97.9% in Cohort 1, 72.4%, 59%, 8.3% and 97.6% in Cohort 2 and 73.7%, 61.0%, 12.2% and 96.9% in Cohort 3, respectively. The higher distribution of risk factors in the UK Cohort means that at the same cut point the score was much more sensitive but also less specific. (sensitivity 92.2%, specificity 25.7%, positive predictive value of 21.6% and negative predictive value of 93.7%). CONCLUSIONS: A diabetes risk score involving simple non-biochemical measurements was developed and validated in a native Asian Indian population. This easily applicable simple score could play an important role as the first step in the process of identifying individuals with an increased likelihood of having prevalent but undiagnosed diabetes. The different distribution of risk factors with the migrant Asian Indians living in England and the different relationship between sensitivity and specificity for the same score demonstrate that risk scores and cut-points developed and tested even within one ethnic group cannot be generalized to individuals of the same ethnic group living in a different cultural setting where the distribution of risk factors for diabetes is different.

Adult↗
PubMedDate not supplied

Diabetes-related comorbidities in Asian Americans: results of a national health survey.

OBJECTIVE: The aim of this study was to compare the prevalence of diabetes-related comorbidities in Asian Americans to the prevalence in other racial and ethnic groups in the United States using data from the 2001 Behavioral Risk Factor Surveillance System (BRFSS). METHODS: The BRFSS is a population-based telephone survey of the health status and health behaviors of 212,510 Americans aged > or = 18 years in all 50 states, Guam, Puerto Rico, and the U.S. Virgin Islands. In 2001, participants included 196 Asian Americans, 1138 African Americans, 1276 Hispanics, 294 Native Americans, 71 Pacific Islanders, and 7799 non-Hispanic Whites with a self-reported physician diagnosis of diabetes. Comorbidity was determined by self-report. Odds ratios (OR) were adjusted for age, sex, body mass index (BMI) or height and weight, duration of diabetes, smoking, and health-insurance status. RESULTS: The adjusted prevalences of hypercholesterolemia and retinopathy were similar across groups. Relative to Asian Americans, only African Americans were more likely to report hypertension [adjusted OR=2.1, 95% confidence interval (CI)=1.0-4.2, P<.05]. Higher odds of current or past foot ulceration was observed for Hispanics (adjusted OR=2.8, 95% CI=1.2-6.9), Native Americans (adjusted OR=4.2, 95% CI=1.4-12.8), and Pacific Islanders (adjusted OR=7.4, 95% CI=1.3-41.2) compared with Asian Americans. CONCLUSIONS: Among Americans with diabetes, Asian Americans have a prevalence of hypertension, hypercholesterolemia, retinopathy, and foot ulceration that is similar to that in Whites. Asian Americans had a significantly lower prevalence of hypertension than African Americans did and a lower prevalence of foot ulceration than Hispanics, Native Americans, and Pacific Islanders did.

Asia↗
PubMed1997

Attitudes of Asian and American graduate nursing students towards death and dying.

This study compared the difference in attitudes towards death and dying between 17 Asian and 11 American graduate nursing students. Asian and American students did not significantly differ in attitudes related to fear of death, of self, or others, but Asian students were significantly more afraid than American students of their own process of dying. Asian students were more averse than American students to interacting and discussing death with dying patients. Talking about death with dying patients was the most difficult aspect of care for both groups. However, Asian students gained more personal satisfaction than American students in caring for dying patients. The findings provoke discussion regarding differences in nursing practice by Asian and American graduate nursing students.

Attitude of Health Personnel↗
PubMed2002

Increased fibrinogen, von Willebrand factor and tissue plasminogen activator levels in insulin resistant South Asian patients with ischaemic stroke.

The aim of this study was to determine differences in atherothrombotic risk factors in South Asian subjects with a history of ischaemic stroke and South Asian subjects free from personal and family history of clinically detectable stroke. Eighty South Asian patients with ischaemic stroke (confirmed on cranial computerised scan) and 80 South Asian controls with similar age and gender distributions were recruited at random. The frequency of hypertension (P=<0.0001), myocardial infarction (P=0.003) and diabetes mellitus (<0.0001) were significantly higher in stroke patients. Stroke patients had lower high-density lipoprotein cholesterol (0.95 vs. 1.1 mmol/l, P=<0.0001), higher plasma glucose (8.1 vs. 6.6 mmol/l, P=0.01) and trendwise higher HBA(1C) (6.4 vs. 6.0%, P=0.09). There was no difference in insulin levels but insulin resistance was significantly higher in stroke patients (3.75 vs. 2.66, P=0.01). Stroke patients showed elevated levels of fibrinogen (3.78 vs. 3.41 mg/dl, P=0.02), von Willebrand factor (1.78 vs. 1.50 IU/ml, P=0.006) and tissue plasminogen activator (12.8 vs. 11.3 ng/ml, P=0.04), but the differences did not persist after adjustment for glucose, triglycerides, HDL, WHR, and BMI. Higher levels of fibrinogen, von Willebrand factor and t-PA in South Asian stroke patients disappeared after adjustment for features of insulin resistance syndrome but persisted after adjustment for presence of diabetes, confirming that these changes are essentially dependant on features of insulin resistance syndrome. A prospective study would be required to elucidate the role of thrombotic risk factors in South Asians with ischaemic stroke.

Asia, Southeastern↗
PubMed1996

Referral of Asian patients to a GI clinic.

This study compared gastrointestinal (GI) symptoms and psychiatric morbidity in consecutive new out-patients presenting to a district general hospital. In a 6-month period 36 patients of South Asian origin were referred to the clinic. They were compared in terms of GI symptoms and psychiatric morbidity with white European controls, both with a large sample of clinic attenders, and with a subsample of 36 matched for age, gender, and diagnosis. A total of 72% (26 of 36) of Asian patients had functional GI disorders compared to 48% (42 of 88) of white patients (p < 0.05). However, comparisons of matched patients showed that Asian patients with functional GI disorders had less severe GI symptoms than the matched white patients, and fewer had psychiatric disorder (23% of Asians and 42% of white Europeans). These results suggest that the threshold for referral for Asian patients with functional GI disorders to hospital clinics is lower than for white patients. Detection and management of somatization in Asian patients in primary care need to be improved, and referral patterns of general practitioners need to be explored in future research.

Adolescent↗
PubMed2000

Decreased chronic lymphocytic leukemia incidence in Asians in Los Angeles County.

Chronic lymphocytic leukemia (CLL) is rare in Asians living in Asia and possibly in US Asians. In contrast, CLL is the most common leukemia in whites. The basis for this ethnic and geographic variation is unknown. We compared average annual age-adjusted incidence rates (AAIR) of CLL diagnosed from 1972 to 1995 among Los Angeles County-resident Asians, non-Spanish-surnamed- and Spanish-surnamed whites (non-Hispanic and Hispanic-whites) and blacks using the University Southern California-Cancer Surveillance Program (USC-CSP), the population-based cancer registry for Los Angeles County. Asian groups studied included Chinese, Japanese, Filipinos and Koreans. Expected numbers of CLL cases were based on the age-adjusted incidence rates in non-Hispanic whites and compared to numbers of cases observed in Chinese, Japanese and Filipinos. Possible association of socioeconomic state (SES) was assessed using AAIRs with SES-specific denominators. In the absence of denominators by birthplace, the association of birthplace and CLL-incidence was evaluated using proportional odds ratios (POR). Los Angeles County Asian males and females had significantly lower AAIRs than non-Hispanic whites (males: AAIR=0.7 per 100000 population, 95% confidence interval (CI), 0.5-1.0 vs. 4.4, 95% CI, 4.3-4.6; and females: AAIR=0.5, 95% CI, 0.3-0.7 vs. 2.3, 95% CI, 2.2-2.4). Fewer Japanese Chinese and Filipinos were diagnosed with CLL than expected (P<0.01). There was no association of birthplace (POR=0.9, 95% CI, 0. 5-1.9) or SES on CLL-risk. CLL-risk was markedly lower in Los Angeles County Asians compared to non-Hispanic whites. Neither birthplace nor socioeconomic state accounted for this difference suggesting a role for genetic or other environmental factors in decreasing CLL-risk.

Adult↗
PubMed1998

Atrial fibrillation amongst the Indo-Asian general practice population. The West Birmingham Atrial Fibrillation Project.

Whilst there are recognised ethnic differences in cardiovascular disease, with a higher prevalence of hypertension and complications such as stroke amongst black/Afro-Caribbean populations, and ischaemic heart disease being more prevalent amongst Indo-Asians, the literature describing the clinical epidemiology of atrial fibrillation (AF) in non-caucasian groups is scarce. To survey the clinical features and management amongst Indo-Asian patients with known AF, we studied patients from six general practices in the west of Birmingham. The six general practices had a combined practice population of 25051, from which, the Indo-Asian population was 14670. A total of 12 Indo-Asian patients (six male, six female; mean age, 67 years; range, 42 to 95 years) with known AF were identified, suggesting a prevalence of AF in Indo-Asians aged >50 years of 0.6%. Six patients had chronic AF, two had recent onset (defined as onset <six months) and four had paroxysmal AF. Five patients had a history of ischaemic heart disease, three had hypertension, seven had heart failure, two had alcohol excess, four had mitral valve disease, and one patient with paroxysmal AF had sick sinus syndrome. None could be classified as having lone AF. Only four patients were anticoagulated, but, of the remaining eight, who were not taking warfarin, six were taking aspirin. None of the patients had contraindications to warfarin, but one of the patients who was taking aspirin had poor compliance to warfarin. In this survey of a general practice Indo-Asian population of approximately 14670, we found 12 patients with known AF. More information on the clinical epidemiology of AF in non-caucasian groups is still needed and urgently required, in view of the public health implications of this common cardiac arrhythmia.

Adult↗
PubMed1987

Comparative prevalence of non-insulin-dependent diabetes mellitus in Asian and white Caucasian adults.

The prevalence of diabetes mellitus in adults was determined within a specific area of Leicester City, containing 20,053 Asians and 18,068 White Caucasian over the age of 16 years in the 1981 census. Subjects who had ever had classical symptoms with a random venous plasma glucose greater than or equal to 11.1 mmol/l were taken as diabetic. Exact numbers were ascertained from an analysis of diabetic clinic records and specialist health visitor records. The latter have formed an important part of community care for diabetics in Leicester for the last 30 years, and patients are referred by hospital consultants and nursing staff, and by general practitioners. Diabetes was ascertained in 967 Asians and 1194 White Caucasians. Age-adjusted relative risk of diabetes (95% confidence interval) increased in Asians over 45 years of age and was 1.6 (1.3-1.8) and 2.7 (2.5-3.2) for those aged 45-64 years and over 65 years, respectively. Relative risk of NIDDM was significantly higher (approximately x 2) in Asians in all age-groups. Our study shows that in Asians the prevalence of diabetes rises above 45 years of age and that NIDDM occurs more frequently in adult Asians. The causes and long-term effects of this require further analysis.

Adolescent↗
PubMed2001

Clinical trials for drug registrations in Asian-Pacific countries: proposal for a new paradigm from a statistical perspective.

The world has become more interdependent in the movement of free trade and global markets. The regulations for approval of new drugs in the Asian markets have always been an important issue in the free trade negotiation between the U.S.- and E.U.-based international manufacturers and the Asian-Pacific countries, since pharmaceuticals are of large trade value for them. In 1998 the University of Hong Kong and the Singapore National Medical Research Council jointly hosted the first Asian Clinical Trials Conference. The Society for Clinical Trials was invited as a collaborator for the event, which signified a milestone for interaction between the East and West in the discussion of clinical trials. Many have participated in the discussion of drug approval and registration issues for the Asian region based on the drug development experience in the United States. However, there are many interesting differences between the two regions, which lead to different approval processes for new drugs developed by the U.S.- and E.U.-based international manufacturers. This article highlights some regulatory dilemmas and some key statistical concepts pertinent to these differences. The purpose of this paper is to resolve the regional regulatory and scientific dilemma. A new paradigm of sample size design and data analysis for drug approval for countries in the Asian-Pacific region is proposed. The central premise is that substantial information from multicenter studies has already shown efficacy in the United States or the European Union when a drug manufacturer seeks marketing approval in an Asian country. This leads to the idea of a "consistency trial" using the method of Bayesian most plausible prediction. The method is illustrated with an example.

Asia↗