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Related Concept Videos

Clinical Trials01:16

Clinical Trials

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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

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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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Insomnia01:27

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Insomnia is a prevalent sleep disorder characterized by difficulty falling asleep, frequent awakenings during the night, and waking up too early without being able to return to sleep. People with insomnia often experience these disruptions at least three nights a week for at least one month. Chronic insomnia, which lasts for at least three months, can lead to increased anxiety, which in turn can worsen sleep difficulties, creating a cycle of sleeplessness and stress.
Multiple factors contribute...
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Statistical Software for Data Analysis and Clinical Trials01:12

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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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Management of Insomnia01:19

Management of Insomnia

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The sleep cycle, an integral part of human health, consists of several stages with distinct characteristics and functions. It begins with a transition from wakefulness to sleep, known as the light sleep phase, followed by the restorative deep sleep phase, essential for physical recovery and growth. The cycle concludes with the Rapid Eye Movement (REM) phase, characterized by high brain activity and vivid dreaming. Insomnia, a prevalent sleep disorder, involves difficulty falling asleep, staying...
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The Representativeness Heuristic02:13

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The representative heuristic describes a biased way of thinking, in which you unintentionally stereotype someone or something. For example, you may assume that your professors spend their free time reading books and engaging in intellectual conversation, because the idea of them spending their time playing volleyball or visiting an amusement park does not fit in with your stereotypes of professors.
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In Silico Clinical Trials for Cardiovascular Disease
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How representative are insomnia clinical trials?

T Roehrs1, J C Verster2, G Koshorek3

  • 1Sleep Disorders & Research Center, Henry Ford Hospital, Detroit, MI, USA; Dept. Psychiatry, SOM, Wayne State University, Detroit, MI, USA.

Sleep Medicine
|August 26, 2018
PubMed
Summary
This summary is machine-generated.

Subjects in hypnotic clinical trials for insomnia are not representative of the general insomnia population. Most initial contacts were excluded due to various criteria, resulting in a highly selected sample for these trials.

Keywords:
Clinical trialRemelteonZolpidemZopiclone

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Area of Science:

  • Clinical Psychology
  • Psychopharmacology
  • Medical Research

Background:

  • Insomnia affects a significant portion of the population, leading to the development of various hypnotic medications.
  • Clinical trials are essential for evaluating the efficacy and safety of these hypnotics.
  • Assessing the representativeness of trial participants is crucial for generalizing findings to the broader patient population.

Purpose of the Study:

  • To determine how representative subjects in clinical trials for hypnotic medications are of the general insomnia population.
  • To analyze initial contact rates and reasons for inclusion/exclusion in two hypnotic clinical trials.

Main Methods:

  • Two clinical trials for Food and Drug Administration (FDA)-approved hypnotics were conducted: one for efficacy (12 months, zolpidem/placebo) and one for safety (driving ability).
  • Participants were screened via telephone interview and clinic visit, meeting Diagnostic Statistical Manual, Fourth Edition, Revised (DSM-IVR) criteria for insomnia.
  • Exclusion criteria included failure to meet insomnia criteria, mental health issues, medical problems, and drug use/abuse history.

Main Results:

  • In the US efficacy trial, only 4% of initial contacts entered the study; in the Netherlands safety trial, 0% entered.
  • Major exclusion reasons included: failing to meet insomnia criteria (25% US, 37% NL), mental health issues (24% US, 23% NL), medical problems (23% US, 9% NL), and drug use/abuse history (20% US, 26% NL).
  • Initial contact to clinic visit rates varied significantly (13% US vs. 67% NL).

Conclusions:

  • Participants in insomnia hypnotic clinical trials represent a highly selected sample.
  • These trial participants are unlikely to be representative of the broader insomnia population.
  • Findings suggest caution when generalizing results from these trials to potential medication users.