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固定到灵活临床试验的样本量

2018 年,91% 获得 FDA 批准临床试验的组织使用 nQuery 进行样本量计算。

获得监管批准

始终如一地计算用于FDA/EMA提交的正确样本量

  • 经验证的样本量表和程序
  • 样本量报表生成器
  • 自动化安装和操作认证程序 (IQ/OQ)

 

降低试验的风险和成本

用于优化试验设计的贝叶斯和自适应技术

  • 通过我们的样本量和功效分析计算器中的贝叶斯模块,了解从您的试验中获得“积极”结果的可能性有多大
  • 减少样本量,同时仍确保结果具有统计意义
  • 中期试验自适应修改的非标准测试统计数据

强大的样本量选项

使用我们的样本量计算器快速计算多种场景的样本量

  • 具有 100 个样本量和功效计算程序的样本量计算器
  • 使用绘图功能,轻松执行各种“假设”场景,使您的最终样本量选择与您的科学和预算要求保持一致
  • 使用指定多因素工具微调计算

 

分享与赋能

轻松将计算传达给您的团队

  • 快速分享您的作品
  • 快速有用的报告工具
  • 一个样本量计算器,可为您的团队赋能

 

 

易于使用且直观

干净快速的电子表格样式界面,无需编码

  • 零手动编码
  • 统计帮助卡
  • 定制表格

 

 

插件模块

2018年春季版本
nQuery Bayes - 新的表格

功能列表 Area
Mixed Bayes/Likelihood for Two Means Equal Variance Credible Intervals
 Unequal Variance Means - Known Precision Credible Intervals
 Unequal Variance Means - Mixed Credible Intervals
 Difference in Two Proportions - Unknown Precision Credible Intervals
 Difference in Two Proportions - Mixed Credible Intervals
 Bayesian Reassessment Methods (Phase 1) Other
 Superiority Assurance for one Proportion Assurance
 Bayesian Assurance for One Group Test of Normal Mean Assurance
 Bayesian Assurance for One Group Test - Uniform Prior Assurance
 Bayesian Assurance for Two Proportions - Beta prior for P1 Assurance
 Bayesian Assurance for Two Proportions - Beta prior for P2 Assurance
 Bayesian Assurance for Two Proportions - Beta prior for P1 and P2 Assurance
 Bayesian Assurance for Mean Difference with Common Variance - Prior for δ and σ² (Simulation) Assurance
Bayesian Assurance for Mean Difference with Uncommon Variance - Prior for δ and each σ² (Simulation) Assurance
Bayesian Assurance for Two Group Non-Inferiority Test of Normal Means - Uniform Prior Assurance
Bayesian Assurance for Two Group Non-Inferiority Test of Normal Means - Uniform Prior Assurance
Bayesian Assurance for Two Group Test of Survival Curves - Normal Prior for log (HR) Assurance
Bayesian Assurance for Two Group Test of Survival Curves - Lognormal Prior for HR Assurance
Bayesian Assurance for Two Group Test of Survival Curves - Inverse Gamma Prior for λt Assurance
Bayesian Assurance for Two Group Test of Survival Curves - Inverse Gamma Prior for λc Assurance

nQuery Bayes 插件模块
(请注意 - 列出的表格仅在您购买 nQuery Bayes 附加模块时可用)

  1. One Sample Bayesian Credible Interval with Known Precision
  2. One Sample Bayesian Credible Interval with Unknown Precision
  3. One Sample Mixed Bayesian Likelihood Average Coverage Criterion with Unknown Precision
  4. Two Sample Bayesian Credible Interval with Known Precision
  5. Two Sample Bayesian Credible Interval with Unknown Precision
  6. Assurance for Two Group Test of Normal Means
  7. Assurance for Equivalence Test of Two Normal Means
  8. Assurance for Non-inferiority Test of Two Normal Means
Bonus 表格
  1. n-of-1 Trials
  2. Gamma Regression

nQuery Advisor + nTerim

nQuery Advisor 7.0现在和nTerim一起发售

nTerim提供用于成组序贯试验(group sequential trial) 的功效和样本大小计算。 nTerim使用Lan&DeMets的alpha消耗函数(alpha-spending function),包括 O’Brien-Fleming,Pocock, Hwang-Shih-DeCani和其他人的消耗函数。

nQuery Advanced Highlights

Expanded Survival Analysis Suite

17 new tables including one and two sample log rank tests, Gehan-Breslow and Tarone-Ware linear-rank tests

Automated Installation & Operational Qualification (IQ/OQ) Procedures

New IQ and OQ tools simplify the process of validating nQuery in regulated industries

Extended Cluster Randomized Trial Suite

New tables for two means, proportions & incidence rates (matched pairs) and two incidence rates (completely randomized)

Modernized Interface, Auto-updates, New nQuery Community & much more

nQuery Bayes Highlights

Optional Add-On Module For Alternative Sample Size Methods

Additional Sample Size Tables

  • One Sample Bayesian Credible Interval with Known Precision
  • One Sample Bayesian Credible Interval with Unknown Precision
  • One Sample Mixed Bayesian Likelihood Average Coverage Criterion with Unknown Precision
  • Two Sample Bayesian Credible Interval with Known Precision
  • Two Sample Bayesian Credible Interval with Unknown Precision
  • Assurance for Two Group Test of Normal Means
  • Assurance for Equivalence Test of Two Normal Means
  • Assurance for Non-inferiority Test of Two Normal Means

Bonus Tables

  • n-of-1 trials
  • Gamma regression

快速和方便的计算您的样本大小和功效

统计功效分析和样本大小决定对于研究设计来说是关键因素。一个太小的研究可能产生不确定的结果,然后一个太大的研究则会浪费稀缺资源。nQuery Advisior样本大小软件可以在两者之间取得平衡!

点击查看Sample Size in 4 Easy Steps

方便生成您的样本大小理由声明

nQuery Advisor样本大小软件出具样本大小/功效决策证明。这些自动的样本大小理由声明使得以FDA/ICH指导方针一致的正确的语言和格式来报告样本大小/功效决策非常方便。

通过方便的自定义图形来比较不同的选项

通过nQuery Advisor的系列图形可以快速的评估大量情境。画出大量参数,比如功效,样本大小,效应值(effect size)等

为众多的统计分析计算样本大小和功效

nQuery Advisor样本大小软件为均值,比率,一致性,回归,幸存分析,非参数检验等计算样本大小和功效。nQuery Advisor同样帮助您提供您需要用来制定样本大小和功效分析计算的标准差和效应值信息。

其他重要的特征

创建随机化列表

Random subset of cases
Select a random subset of n cases from N subjects

Randomization list (Basic)
Enter names for the groups and the total sample size

Randomization list (Advanced/Complex)

For designs with unequal sample sizes, centers/strata, choice of block sizes, mixed block sizes, randomization seed, etc.

Distributions Functions

z (Gaussian / Normal) Distribution
t (Central)
t (Non-Central)
χ2 (Central)
χ2 (Non-Central)
F (Central)
F (Non-Central)
Cumulative Binomial

杂项特征

Equal or nonequal n’s
Finite population corrections
Cluster sample corrections
Kupper-Hafner CI modifications
Plots
Sample size justification statements
Effect size assistance
References
Standard deviation calculator
Column names
Tables, statements, guides in RTF format
Decimal display controls

 

 

购买咨询

有关nQuery Advanced软件的更多信息,请联系产品代表:

400-621-1085
021-50391087

或点击下面的链接直接在线提交购买咨询信息

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2021/3/2