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Related Concept Videos

Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
Comparing the Survival Analysis of Two or More Groups01:20

Comparing the Survival Analysis of Two or More Groups

Survival analysis is a cornerstone of medical research, used to evaluate the time until an event of interest occurs, such as death, disease recurrence, or recovery. Unlike standard statistical methods, survival analysis is particularly adept at handling censored data—instances where the event has not occurred for some participants by the end of the study or remains unobserved. To address these unique challenges, specialized techniques like the Kaplan-Meier estimator, log-rank test, and Cox...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Kaplan-Meier Approach01:24

Kaplan-Meier Approach

The Kaplan-Meier estimator is a non-parametric method used to estimate the survival function from time-to-event data. In medical research, it is frequently employed to measure the proportion of patients surviving for a certain period after treatment. This estimator is fundamental in analyzing time-to-event data, making it indispensable in clinical trials, epidemiological studies, and reliability engineering. By estimating survival probabilities, researchers can evaluate treatment effectiveness,...
Study Design in Statistics01:15

Study Design in Statistics

A study design is a set of techniques that allow a researcher to collect and analyze data from different variables defined for a specific research problem. Statistics is commonly for effective study design and more robust experiments,
Does aspirin reduce the risk of heart attacks? Is one brand of fertilizer more effective at growing roses than another? Is fatigue as dangerous to a driver as the influence of alcohol? Questions like these are answered using randomized experiments with proper...

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Updated: Jun 26, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
04:53

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

Statistical methods for targeted clinical trials under enrichment design.

Jen-Pei Liu1, Jr-Rung Lin

  • 1Division of Biometry, Graduate Institute of Agronomy, National Taiwan University, Taipei, and Division of Biostatistics and Bioinformatics, National Health Research Institutes, Zhunan, Taiwan. jpliu@ntu.edu.tw

Journal of the Formosan Medical Association = Taiwan Yi Zhi
|January 9, 2009
PubMed
Summary

New statistical methods provide unbiased treatment effect inference for targeted therapies, accounting for diagnostic inaccuracies in patients with molecular targets. This improves precision medicine outcomes.

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Pretargeted Radioimmunotherapy Based on the Inverse Electron Demand Diels-Alder Reaction

Published on: January 29, 2019

Area of Science:

  • Biostatistics
  • Genomics
  • Precision Medicine

Background:

  • The Human Genome Project enables identification of molecular targets for disease treatment.
  • Individualized treatment strategies are advancing, but diagnostic inaccuracies pose challenges.
  • Current statistical inference for targeted therapies can be biased due to imperfect diagnostic devices.

Purpose of the Study:

  • To develop statistical methods for unbiased inference of treatment effects.
  • To address biased statistical inference in targeted therapy for patients with molecular targets.
  • To account for diagnostic device inaccuracies in evaluating treatment efficacy.

Main Methods:

  • Proposed expectation maximization (EM) algorithm with bootstrap for binary data under enrichment design.
  • Incorporated diagnostic device inaccuracy for robust treatment effect inference.
  • Conducted simulation studies and a numerical example to validate methods.

Main Results:

  • The proposed estimation method demonstrated unbiasedness with adequate precision.
  • Confidence intervals achieved satisfactory coverage probability.
  • The testing procedure controlled statistical size and provided sufficient power, revealing significant treatment effects when diagnostic inaccuracy was considered.

Conclusions:

  • The developed estimation and testing procedures offer adequate statistical methods.
  • These methods enable reliable inference of treatment effects for patients with molecular targets.
  • Accurate statistical inference is crucial for effective targeted therapy in precision medicine.