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Related Concept Videos

Clinical Trials01:16

Clinical Trials

10.3K
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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Statistical Software for Data Analysis and Clinical Trials01:12

Statistical Software for Data Analysis and Clinical Trials

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Statistical software is pivotal in data analysis and clinical trials by providing tools to analyze data, draw conclusions, and make predictions. These software packages range from simple data management applications to complex analytical platforms, supporting various statistical tests, models, and simulation techniques. Their significance lies in their ability to handle vast amounts of data with precision and efficiency, enabling researchers to validate hypotheses, identify trends, and make...
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The Evidence for Evolution02:55

The Evidence for Evolution

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Genetic variations accumulating within populations over generations give rise to biological evolution. Evolutionary changes can result in the formation of novel varieties and entire new species. These changes are responsible for the diverse forms of life inhabiting the planet. The evidence for evolution suggests that all living organisms descended from common ancestors.
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Convergent Evolution01:54

Convergent Evolution

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Evolution shapes the features of organisms over time, ensuring that they are suited for the environments in which they live. Sometimes, selection pressure leads to the rise of similar but unrelated adaptations in organisms with no recent common ancestors, a process known as convergent evolution.
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Eukaryotic Evolution01:24

Eukaryotic Evolution

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The endosymbiont theory is the most widely accepted theory of eukaryotic evolution; however, its progression is still somewhat debated. According to the nucleus-first hypothesis, the ancestral prokaryote first evolved a membrane to enclose DNA and form the nucleus. Conversely, the mitochondria-first hypothesis suggests that the nucleus was formed after endosymbiosis of mitochondria.
Contrary to the endosymbiont theory, the eukaryote-first hypothesis proposes that the simpler prokaryotic and...
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The Multiple Sclerosis Performance Test MSPT: An iPad-Based Disability Assessment Tool
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The Multiple Sclerosis Performance Test MSPT: An iPad-Based Disability Assessment Tool

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Evolution of clinical trials in multiple sclerosis.

Yinan Zhang1, Amber Salter2, Erik Wallström3

  • 1Department of Neurology and Neurotherapeutics, the University of Texas Southwestern Medical Center, Dallas, TX, USA.

Therapeutic Advances in Neurological Disorders
|March 6, 2019
PubMed
Summary
This summary is machine-generated.

Clinical trials for multiple sclerosis (MS) have evolved with disease-modifying therapies (DMTs). Modern trials now use active comparators instead of placebos, increasing costs but improving ethical standards for relapsing-remitting MS.

Keywords:
clinical trialsdiagnostic criteriamultiple sclerosisoutcome measureprogressive multiple sclerosistrial design

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A Protocol for the Use of Remotely-Supervised Transcranial Direct Current Stimulation tDCS in Multiple Sclerosis MS
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Area of Science:

  • Neurology
  • Clinical Trial Design
  • Pharmacology

Background:

  • Disease-modifying therapies (DMTs) have transformed multiple sclerosis (MS) treatment.
  • MS clinical trials have adapted to the availability of effective DMTs.

Purpose of the Study:

  • To review significant changes in MS clinical trial methodologies.
  • To discuss the implications of DMTs on trial design and ethics.
  • To highlight advancements in trials for progressive MS.

Main Methods:

  • Analysis of historical and contemporary MS clinical trial designs.
  • Examination of ethical considerations regarding placebo use in DMT trials.
  • Review of strategies to enhance trial efficiency and outcome measures.

Main Results:

  • Modern MS patients in trials present earlier with milder disease.
  • Placebo-controlled trials are no longer ethical for relapsing-remitting MS (RRMS).
  • Active comparator arms increase trial costs due to larger sample size requirements.
  • Adaptive designs and MRI measures improve RRMS trial efficiency.
  • Progressive MS (PMS) trials face challenges with sensitive outcome measures, but new paraclinical measures and neuroprotective agents are emerging.

Conclusions:

  • MS clinical trials have shifted towards active comparators and adaptive designs.
  • Improved outcome measures are crucial for advancing treatments in progressive MS.
  • Ongoing research focuses on neuroprotection and remyelination strategies for MS.