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1.
《Statistics In Biopharmaceutical Research》2013,5(2):153-164
The objective of dose-finding trials is to identify the doses that are sufficiently effective and safe for either future late-phase trials or the ultimate patients. Most methodologies for analyzing data from Phase II dose-finding trials mainly focus on finding the effective doses or minimum effective dose through hypothesis testing, while Phase I studies focus on finding the maximum tolerated dose. In this article, we focus on benefit–risk assessment through both hypothesis testing and point estimation. For purposes of efficiency, monotone dose–response relationships will be assumed for the safety parameter. However, the monotone assumption cannot be made directly for the benefit–risk measure. This consideration can limit the use of downward or upward sequential procedures for multiplicity adjustment for benefit-risk assessment. Several different approaches will be discussed and evaluated. Numerical and data examples will be used to illustrate the properties of these approaches. 相似文献
2.
Arming the immune system against cancer has emerged as a powerful tool in oncology during recent years. Instead of poisoning a tumor or destroying it with radiation, therapeutic cancer vaccine, a type of cancer immunotherapy, unleashes the immune system to combat cancer. This indirect mechanism‐of‐action of vaccines poses the possibility of a delayed onset of clinical effect, which results in a delayed separation of survival curves between the experimental and control groups in therapeutic cancer vaccine trials with time‐to‐event endpoints. This violates the proportional hazard assumption. As a result, the conventional study design based on the regular log‐rank test ignoring the delayed effect would lead to a loss of power. In this paper, we propose two innovative approaches for sample size and power calculation using the piecewise weighted log‐rank test to properly and efficiently incorporate the delayed effect into the study design. Both theoretical derivations and empirical studies demonstrate that the proposed methods, accounting for the delayed effect, can reduce sample size dramatically while achieving the target power relative to a standard practice. Copyright © 2016 John Wiley & Sons, Ltd. 相似文献
3.
Earl Hopper 《British Journal of Psychotherapy》2009,25(2):214-229
Presented in honour of Dr Estela Welldon as a friend and colleague, and in acknowledgement of her contributions to forensic psychotherapy and group analysis for people who suffer from extreme anxieties associated with confused sex and gender identifications and choices, sado-masochism and criminality, this article integrates Bionian and Foulkesian perspectives in group analysis by conceptualizing a fourth basic assumption in the unconscious life of social systems. The basic assumption of Incohesion: Aggregation/Massification or (ba) I:A/M is derived from a relational rather than an instinctual metapsychology, and assumes that helplessness and the fear of annihilation precede the emergence of envy, thus emphasizing the importance of traumatogenic processes. Traumatized people with crustacean and amoeboid defences/protections against the fear of annihilation are likely to personify aggregation and massification processes, respectively. This theory can be applied in the group treatments of our most disturbed patients, and in understanding the dynamics of traumatized social systems, ranging from families to organizations and even societies. 相似文献
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《Substance use & misuse》2013,48(3):489-509
The existing literature on drinking patterns of Black alcoholics is relatively limited; however, most of the data suggest that drinking behavior of Blacks may be different from that of Whites. A summary of recent studies in this area is presented in Table 1. Robins et al. (1968) indicated that heavy drinking is a common pattern among Black urban males and that drinking behavior usually resulted in objective difficulties and personal worry. Maddox and Williams (1968) reported that drinking is twice as common in urban Black men as in urban White men of similar socioeconomic class origins. King et al. (1969), in a study of the social problems of Black men, demonstrated the significance of alcohol abuse in the Black urban ghetto and how this related to broken homes, delinquency, sexual and reproductive irresponsibility, and underemployment. 相似文献
7.
Robert J Casson DPhil FRANZCO Lachlan DM Farmer MBBS 《Clinical & experimental ophthalmology》2014,42(6):590-596
Linear regression (LR) is a powerful statistical model when used correctly. Because the model is an approximation of the long‐term sequence of any event, it requires assumptions to be made about the data it represents in order to remain appropriate. However, these assumptions are often misunderstood. We present the basic assumptions used in the LR model and offer a simple methodology for checking if they are satisfied prior to its use. In doing so, we aim to increase the effectiveness and appropriateness of LR in clinical research. 相似文献
8.
现行医院会计制度存在的问题及其改革设想 总被引:4,自引:0,他引:4
完善医院会计制度是准确核算医院财务状况的前提。随着经济环境的变迁和卫生改革的深入,现行医院会计制度的局限性正日益凸现, 必须对其加以改进。 相似文献
9.
The suicide substrate reaction is a model for certain enzyme-inhibitingdrugs. This reaction system is examined assuming that the substratediffuses freely while the enzyme remains fixed. Two sets ofinitial and boundary conditions are examined: one modellingan instantaneous point source, akin to an injection of substrate,the other, a continuous point source, akin to a continuing influx,or intravenous drip, of substrate. The quasi-steady-state assumptionis applied to obtain analytical solutions for a limited parameterspace. Finally, further applications of numerical and analyticalexperimentation on pharmaceutical mechanisms are described. 相似文献
10.
The equal-environment assumption (EEA), upon which twin methodology is based, was examined for the impact of physical similarity on phenotypic resemblance in five common psychiatric disorders: major depression, generalized anxiety disorder, phobia, alcoholism, and bulimia. A population-based sample of 882 female-female twin pairs of known zygosity was rated for similarity of appearance by color photographs. Psychiatric diagnoses were made by clinical assessment of personal interviews of the twins. Structural equation modeling of the data using physical similarity as a form of specified common environment provided no evidence for a significant effect of physical resemblance on concordance for major depression, generalized anxiety disorder, phobia, and alcoholism, thereby supporting the validity of the EEA in twin studies of these disorders. Results for bulimia, on the other hand, suggest, within the limitations of this study, that physical similarity may significantly influence twin resemblance for this disorder. 相似文献