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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

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

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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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Clinical Applications of Epidermal Stem Cells01:19

Clinical Applications of Epidermal Stem Cells

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Epidermal stem cells (EpiSCs) are mainly located at the basal layer of the epidermis. These cells repair minor injuries of the skin and replace dead skin cells. However, EpiSCs’ cannot heal severe wounds such as major burns or those from diabetes or hereditary disorders. In such cases, culturing the epidermal stem cells from the patient is possible and has yielded successful treatment options, such as laboratory-grown skin grafts. These grafts are synthesized using a patient’s own...
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Immunological Memory01:23

Immunological Memory

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Immunological memory, a pivotal pillar of the adaptive immune system, is responsible for the body's ability to remember and respond more swiftly and effectively to previously encountered pathogens. This remarkable feature is what makes vaccines so effective in preventing diseases.
What is Immunological Memory?
Immunological memory is an integral function of the immune system that allows it to recognize and react more rapidly and effectively to pathogens previously encountered. This feature...
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Local Anesthetics: Clinical Application as Spinal Anesthesia01:11

Local Anesthetics: Clinical Application as Spinal Anesthesia

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Spinal anesthetics are given during lower abdomen and limb surgeries to block sensory and motor neurons. They are administered in the mid to low lumbar regions, primarily acting on the cauda equina's nerve roots. The blockade level depends on the local anesthetic (LA) concentration. Usually, low LA concentrations are sufficient to block sensory fibers, while only high LA concentrations block motor fibers. Other factors like injection volume and speed, the patient's posture, and the drug...
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Application of immunologic methods in clinical trials

W C Buhles1

  • 1Clinical Science Consulting, Santa Clara, CA 95054, USA. wbuhles@msn.com

Toxicology
|October 13, 1998
PubMed
Summary

Evaluating a new drug

Area of Science:

  • Immunology
  • Clinical Pharmacology
  • Drug Development

Background:

  • Pharmaceuticals are typically assessed using in vitro and animal models.
  • Early clinical trials offer opportunities to evaluate drug immunologic effects in humans.
  • Immunologic response measures are increasingly used as surrogate clinical endpoints.

Purpose of the Study:

  • To explore the evaluation of immunologic activity of pharmaceutical molecules in early human clinical trials.
  • To highlight the utility of non-invasive immunologic measures in assessing drug effects.
  • To emphasize the importance of robust clinical trial design for immunologic assessments.

Main Methods:

  • Utilizing non-invasive measures to assess immune enhancement or suppression.
  • Detecting and quantifying both antibody and cellular immune responses to the drug molecule in human subjects.

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  • Employing early clinical trial stages for immunologic evaluation.

    • Main Results:

    • Non-invasive methods can effectively determine if a test molecule modulates immunity.
    • Both humoral (antibody) and cellular immune responses to novel pharmaceutical agents can be measured in humans.
    • Immunologic parameters can be successfully integrated into clinical trial designs.

    Conclusions:

    • Human clinical trials provide a viable platform for assessing drug immunologic effects.
    • Careful protocol development, site selection, and laboratory evaluation are crucial for successful immunologic endpoint integration.
    • Immunologic assessments in early drug development can inform regulatory decisions and patient outcomes.