2. 您的位置
3. 首页
4. 会议论文
5. Sequential safety monitoring for alerting and stopping a development program

Sequential safety monitoring for alerting and stopping a development program

来源 :上海交通大学 | 被引量 : 0次 | 上传用户：coni

【摘 要】

：

In pivotal Phase 3 trials where adverse events have been identified in advance,regulatory requirements often call for development programs to adequately demonstrate an acceptable drug safety profile.

【作 者】

：

Fei Chen 

【机 构】

：

Janssen Pharmaceutical Research & Development,Raritan,NJ 08812,USA

【出 处】

：

上海交通大学

【发表日期】

：

2016年4期

【关键词】

：

Sequential safety monitoring Multiplicity 

下载到本地 , 更方便阅读

下载此文 赞助VIP

声明 : 本文档内容版权归属内容提供方 , 如果您对本文有版权争议 , 可与客服联系进行内容授权或下架

论文部分内容阅读

　　In pivotal Phase 3 trials where adverse events have been identified in advance,regulatory requirements often call for development programs to adequately demonstrate an acceptable drug safety profile.

其他文献

On testing a high-dimensional white noise

Testing for white noise is a classical yet important problem in statistics,especially for diagnostic checks in time series modeling.

会议

large auto-covariance matrixHosking's testLi-McLeod testhigh-dimensional

The AVaR Optimization Problems for semi-Markov Decision Processes

This talk discusses the average value-at-risk(AVaR)criterion for finite horizon semi-Markov decision processes(SMDPs)in continuous-time.

会议

Semi-Markov decision processesfinite horizon costaverage value-at-riskvalue i

Some optimization problems for the risk model with dependence structure

In this talk,I will give some kinds of risk model with dependence structure,and some criteria under which we discuss the optimization problems.

会议

Hamilton-Jacobi-Bellman equationDependence structureInvestmentProportional re

DATA SCIENCE:NOVEL TRAINING PROGRAMS

Data Science programs,including academic,professional,short course and boot-camps,now abound worldwide.

会议

Data scienceLearning experienceStatistical methodsTraining programs

Prediction of long term outcome from pathological complete response for early breast cancer

As the treatments for breast cancer improve,disease free survival time is extensively prolonged and pharmaceutical developer faces a new challenge in clinical trial design and conduct based on long te

会议

Sequential Monte Carlo of dynamic network for animal population estimation

We propose a dynamic network model for the evolution of an open animal population that is subject to an environmental catastrophe.

会议

Capture-recapturehybrid MCMCpopulation sizesequential importance sampling

A Bayesian logistic regression model with cohort size adaptation based on posterior probabilities in

The primary objective of cancer phase Ⅰ studies is to determine the maximum tolerated dose(MTD).

会议

Bayesian logistic regression modeldose-findingcohort size adaptationphase Ⅰ c

A Nonparametric Composite Likelihood Approach to Multiple Change-Point Problems

In this talk,we will talk about embedding a non-parametric multiple change-point problem into a parametric framework.

会议

Composite likelihoodDNA copy number alterationsMultiple change-pointsPermutat

Optimal Sequential Enrichment Designs for Phase Ⅱ Clinical Trials

In the early phase development of molecularly targeted agents(MTAs),a commonly encountered situation is that the MTA is expected to be more effective for a certain biomarker subgroup,say marker-positi

会议

subgroupspersonalized medicinemolecularly targeted agentsphase Ⅱ trials

Statistical Inference for Functional Partial Linear Model with Missing Response at Random

In this paper,we consider functional partial linear models proposed by Lian(2011)when the response variables are missing at random.

会议

Functional Partial Linear ModelsMissing at RandomPolynomial SplineFunctional