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Related Concept Videos

Clinical Trials01:16

Clinical Trials

10.4K
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...
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Clinical Trials: Overview01:11

Clinical Trials: Overview

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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...
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Trends in Lattice Energy: Ion Size and Charge02:54

Trends in Lattice Energy: Ion Size and Charge

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An ionic compound is stable because of the electrostatic attraction between its positive and negative ions. The lattice energy of a compound is a measure of the strength of this attraction. The lattice energy (ΔHlattice) of an ionic compound is defined as the energy required to separate one mole of the solid into its component gaseous ions. For the ionic solid sodium chloride, the lattice energy is the enthalpy change of the process:
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Sample Size Calculation01:19

Sample Size Calculation

6.7K
Knowledge of the sample size is the first requirement to conduct random sampling or an experiment. The sample size is the total number of units, observations, or groups (in some cases) used to get the data to estimate a population parameter. As the name suggests, the sample size is that of the sample drawn from the population and differs from the population size.
The sample size for the given experiment or sampling effort is fundamental to any study design. Sample size decides the number of...
6.7K
The Binomial Theorem01:30

The Binomial Theorem

323
The Binomial Theorem is a foundational principle in algebra used to expand expressions raised to a power. It provides a structured approach for expanding binomials of the form (a+b)n, where a and b are variables or constants representing algebraic expressions, and n is a non-negative integer.The general form of the Binomial Theorem is:Each term in the expansion involves a binomial coefficient, which is calculated using factorials:The exponent of a in each term decreases from n to 0, while the...
323
Longitudinal Research02:20

Longitudinal Research

13.3K
Sometimes we want to see how people change over time, as in studies of human development and lifespan. When we test the same group of individuals repeatedly over an extended period of time, we are conducting longitudinal research. Longitudinal research is a research design in which data-gathering is administered repeatedly over an extended period of time. For example, we may survey a group of individuals about their dietary habits at age 20, retest them a decade later at age 30, and then again...
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Related Experiment Video

Updated: Jan 31, 2026

Characterizing Exon Skipping Efficiency in DMD Patient Samples in Clinical Trials of Antisense Oligonucleotides
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Characterizing Exon Skipping Efficiency in DMD Patient Samples in Clinical Trials of Antisense Oligonucleotides

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Sample size re-estimation for clinical trials with longitudinal negative binomial counts including time trends.

Thomas Asendorf1, Robin Henderson2, Heinz Schmidli3

  • 1Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.

Statistics in Medicine
|December 22, 2018
PubMed
Summary

This study introduces a new method for adjusting clinical trial sample sizes mid-trial, improving accuracy for disease progression markers like magnetic resonance imaging (MRI) lesion counts in multiple sclerosis.

Keywords:
adaptive designgamma frailtylesion countsnegative binomialsample size re-estimation

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Area of Science:

  • Biostatistics
  • Clinical Trial Design
  • Neuroimaging

Background:

  • Longitudinal lesion counts from magnetic resonance imaging (MRI) are crucial for tracking disease progression in conditions like multiple sclerosis.
  • Clinical trials often face uncertainty in sample size due to complex, overdispersed count data and nuisance parameters.

Purpose of the Study:

  • To develop a novel blinded sample size re-estimation procedure for longitudinal count data in clinical trials.
  • To address limitations of existing methods by allowing for time trends in mean response, unlike time-constant assumptions.

Main Methods:

  • Proposed a new statistical modeling approach for longitudinal count data with time trends.
  • Conducted a simulation study to compare blinded re-estimation with fixed sample size designs.
  • Applied the procedure to magnetic resonance imaging (MRI) data from a multiple sclerosis clinical trial.

Main Results:

  • Blinded sample size re-estimation procedures maintain desired statistical power.
  • The proposed method effectively controls the Type I error rate.
  • The procedure demonstrated practical utility on real-world multiple sclerosis MRI data.

Conclusions:

  • The new modeling approach enhances the reliability of sample size adjustments in ongoing clinical trials.
  • This method offers a flexible and robust alternative for studies with longitudinal count outcomes, particularly in neurodegenerative diseases.
  • Accurate sample size determination is critical for efficient and ethical clinical trial conduct.