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Related Concept Videos

Clinical Trials01:16

Clinical Trials

10.9K
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...
10.9K
Clinical Trials: Overview01:11

Clinical Trials: Overview

5.1K
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...
5.1K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

488
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,...
488
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

165
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
165
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

292
Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
292
Hazard Ratio01:12

Hazard Ratio

641
The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial...
641

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

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Clinical Trial and Registry Data.

Melinda Gooderham, Kim Papp

    Current Problems in Dermatology
    |November 14, 2017
    PubMed
    Summary
    This summary is machine-generated.

    Biologic therapies, including TNF-, IL-12/23-, and IL-17-antagonists, are safe for short- and long-term use. Registries complement clinical trials by confirming safety and efficacy in diverse patient populations.

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    In Silico Clinical Trials for Cardiovascular Disease
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    Area of Science:

    • Immunology and Pharmacology
    • Clinical Trial Design and Biologics
    • Patient Safety and Real-World Evidence

    Background:

    • Physicians depend on pivotal trial data for treatment decisions, but questions about rare events and generalizability persist.
    • Clinical trials provide robust data, yet registries offer complementary insights into real-world effectiveness and safety.
    • Registries evaluate broad patient populations, extending safety observations beyond clinical trial parameters.

    Purpose of the Study:

    • To review safety data from phase 3 clinical trials, long-term extension studies, and biologics registries.
    • To assess the safety profiles of Tumor Necrosis Factor (TNF)-, Interleukin (IL)-12/23-, and IL-17-antagonists.
    • To consolidate and extend safety observations for biologic therapies in patient management.

    Main Methods:

    • Review of phase 3 clinical trial data.
    • Analysis of long-term extension studies.
    • Evaluation of biologics registries for safety and effectiveness.

    Main Results:

    • Biologics demonstrate a safe profile for both short- and long-term utilization.
    • TNF-, IL-12/23-, and IL-17-antagonists exhibit comparable safety regarding infections, malignancy, and cardiovascular events.
    • Screening effectively manages tuberculosis activation risk with TNF agonists; IL-17 blockade is associated with candida infections and inflammatory bowel disease.

    Conclusions:

    • Biologic therapies are a safe treatment option supported by clinical trials and real-world registry data.
    • Different biologic classes (TNF, IL-12/23, IL-17 antagonists) have similar overall safety profiles, with specific considerations for each.
    • Understanding and managing specific risks, such as tuberculosis with TNF agonists and infections/IBD with IL-17 antagonists, is crucial for patient care.