审判委员会制度重塑

作为我国独特创举的审判委员会制度,长期以来为学界所争议。总体上看,当下我国法律界对其的批评已逐渐成为主流,并且主要指向审判委员会"审判分离"、侵犯当事人诉讼权利、行政化倾向严重、责任分担不明等问题。在试图对审判委员会制度的历史沿革及现状进行剖析的基础之上,尝试提出初步的改革设想,使这一具有中国特色的诉讼制度能够符合司法审判的规律,满足司法审判实践的要求。     

Monte-Carlo Sensitivity Analysis for Controlled Direct Effects Using Marginal Structural Models in the Presence of Confounded Mediators

In randomized trials, investigators are frequently interested in estimating the direct effect of a treatment on an outcome that is not relayed by intermediate variables, in addition to the usual intention-to-treat (ITT) effect. Even if the ITT effect is not confounded due to randomization, the direct effect is not identified when unmeasured variables affect the intermediate and outcome variables. Although the unmeasured variables cannot be adjusted for in the models, it is still important to evaluate the potential bias of these variables quantitatively. This article proposes a sensitivity analysis method for controlled direct effects using a marginal structural model that is an extension of the sensitivity analysis method of unmeasured confounding introduced in the context of observational studies. The proposed method is illustrated using a randomized trial of depression.     

Adaptive Crossover Design for Normal Responses

In a response-adaptive design, we review and update the trial on the basis of outcomes in order to achive a specific goal. In clinical trials our goal is to allocate a larger number of patients to the better treatment. In the present paper, we use a response adaptive design in a two-treatment two-period crossover trial where the treatment responses are continuous. We provide probability measures to choose between the possible treatment combinations AA, AB, BA, or BB. The goal is to use the better treatment combination a larger number of times. We calculate the allocation proportions to the possible treatment combinations and their standard errors. We also derive some asymptotic results and provide solutions on related inferential problems. The proposed procedure is compared with a possible competitor. Finally, we use a data set to illustrate the applicability of our proposed design.     

An efficient sequential design of clinical trials

We propose an efficient group sequential monitoring rule for clinical trials. At each interim analysis both efficacy and futility are evaluated through a specified loss structure together with the predicted power. The proposed design is robust to a wide range of priors, and achieves the specified power with a saving of sample size compared to existing adaptive designs. A method is also proposed to obtain a reduced-bias estimator of treatment difference for the proposed design. The new approaches hold great potential for efficiently selecting a more effective treatment in comparative trials. Operating characteristics are evaluated and compared with other group sequential designs in empirical studies. An example is provided to illustrate the application of the method.     

Operating Characteristics for Group Sequential Trials Monitored Under Fractional Brownian Motion

Brownian motion has been used to derive stopping boundaries for group sequential trials, however, when we observe dependent increment in the data, fractional Brownian motion is an alternative to be considered to model such data. In this article we compared expected sample sizes and stopping times for different stopping boundaries based on the power family alpha spending function under various values of Hurst coefficient. Results showed that the expected sample sizes and stopping times will decrease and power increases when the Hurst coefficient increases. With same Hurst coefficient, the closer the boundaries are to that of O'Brien-Fleming, the higher the expected sample sizes and stopping times are; however, power has a decreasing trend for values start from H = 0.6 (early analysis), 0.7 (equal space), 0.8 (late analysis). We also illustrate study design changes using results from the BHAT study.     

公正的网络道德审判是否可能?——基于旁观者视角

网络道德审判是对传统道德审判的继承与发展,存在着显著的伦理困境：它理应通过激发正向羞耻感来促进对行为者的伦理教化,但在诸多情况中却因引发负向羞耻感而产生对行为者的伦理排斥。网络道德审判作为一种典型的道德评价形态,可以利用情感主义伦理学中的旁观者视角来加以考察。据此可发现,网络旁观者的同情、想象、事实判断能力存在着诸多困境,同时其群体性特征又进一步加剧了潜在的风险。实现公正的网络道德审判,需要汲取和借鉴“公正的旁观者”的多重意蕴来构建可能的伦理进路。     

Bayesian sample size determination for phase IIA clinical trials using historical data and semi‐parametric prior's elicitation

The Simon's two‐stage design is the most commonly applied among multi‐stage designs in phase IIA clinical trials. It combines the sample sizes at the two stages in order to minimize either the expected or the maximum sample size. When the uncertainty about pre‐trial beliefs on the expected or desired response rate is high, a Bayesian alternative should be considered since it allows to deal with the entire distribution of the parameter of interest in a more natural way. In this setting, a crucial issue is how to construct a distribution from the available summaries to use as a clinical prior in a Bayesian design. In this work, we explore the Bayesian counterparts of the Simon's two‐stage design based on the predictive version of the single threshold design. This design requires specifying two prior distributions: the analysis prior, which is used to compute the posterior probabilities, and the design prior, which is employed to obtain the prior predictive distribution. While the usual approach is to build beta priors for carrying out a conjugate analysis, we derived both the analysis and the design distributions through linear combinations of B‐splines. The motivating example is the planning of the phase IIA two‐stage trial on anti‐HER2 DNA vaccine in breast cancer, where initial beliefs formed from elicited experts' opinions and historical data showed a high level of uncertainty. In a sample size determination problem, the impact of different priors is evaluated.     

我国民事证据交换制度的反思与完善

证据交换制度作为我国民事审判方式改革进程中的重要内容,对于完善审理结构、提高诉讼效率和质量、实现集中审理具有重要意义.在推进以审判为中心的诉讼制度改革的背景下,针对司法实践中证据交换制度适用率较低的现状,需要进一步完善证据交换制度的程序设计,明确证据交换的实施主体、组织方式及法律效果,从而更好地发挥证据交换制度的作用.     

刑事侦查模式与审判模式的机制冲突

修改后的《刑事诉讼法》第一次出现了'公正审判'一词,在刑事审判阶段大量吸收英美法系当事人主义的审判模式内容,使校辩双方地位趋于平等化。但侦查阶段,我国始终奉行的是职权主义模式,几千年义务本位的法文化背景直接或间接地使犯罪嫌疑人和被告人地位的实际客体化,从而使犯罪嫌疑人和辩护人与国家侦查机关的地位不平等,没有达到'公正侦查',以至于形成'控'、'辩'前提条件不完备的诉讼结构失衡,我们所期待的公正审判将只能是一座空中楼阁。因此笔者试图在我国侦查阶段引入以'弹劾制'侦查现为支撑的当事人主义侦查摸式,使其与当事人主义趋向的庭审相适应、并且适当做好侦查与庭审之间的衔接工作,以完善我国刑事诉讼运行体制。     

A Parametric Estimation Procedure for Relapse Time Distributions

In a relapse clinical trial patients who have recovered from some recurrent disease (e.g.,ulcer or cancer) are examined at a number of predetermined times. A relapse can be detected either at one of these planned inspections or at a spontaneous visit initiated by the patient because of symptoms. In the first case the observations of the time to relapse, X, is interval-censored by two predetermined time-points. In the second case the upper endpoint of the interval is an observation of the time to symptoms,Y . To model the progression of the disease we use a partially observable Markov process. This approach results in a bivariate phase-type distribution for the joint distribution of (X,Y). It is a flexible model which contains several natural distributions for X, and allows the conditional distributions of the marginals to smoothly depend on each other. To estimate the distributions involved we develop an EM-algorithm. The estimation procedure is evaluated and compared with a non-parametric method in a couple of examples based on simulated data.