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Related Concept Videos

Clinical Trials01:16

Clinical Trials

6.9K
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...
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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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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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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,...
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Chronic Pancreatitis I: Introduction01:24

Chronic Pancreatitis I: Introduction

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The pancreas, an elongated and flat gland situated behind the stomach, serves a vital function in digesting food and managing blood sugar levels.
Pancreatitis is the inflammation of the pancreas, which occurs when the immune system becomes active and causes swelling, pain, and disruptions in organ function. Pancreatitis can manifest as either an acute or chronic condition.
Acute pancreatitis arises suddenly and lasts for a brief duration, while chronic pancreatitis is a long-term affliction...
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Preclinical Development: Overview01:28

Preclinical Development: Overview

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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Chronic Pancreatitis II: Collaborative Care01:29

Chronic Pancreatitis II: Collaborative Care

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The management of chronic pancreatitis is multifaceted, involving a comprehensive approach that includes thorough assessment, diagnostic testing, and a variety of management strategies.
Assessment:
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Incorporation of a Survivable Liver Biopsy Procedure in Mice to Assess Non-alcoholic Steatohepatitis NASH Resolution
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Clinical Trial Landscape in NASH.

Stephen A Harrison1, Rohit Loomba2, Julie Dubourg3

  • 1Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom; Pinnacle Clinical Research, San Antonio, Texas.

Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association
|April 14, 2023
PubMed
Summary
This summary is machine-generated.

Nonalcoholic steatohepatitis (NASH) treatments are advancing, with promising results from recent clinical trials and a potential FDA approval in 2023. This review covers drug development, mechanisms, and challenges for effective NASH therapies.

Keywords:
CirrhosisLiverNAFLDNASH

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Area of Science:

  • Hepatology and Gastroenterology
  • Pharmacology and Drug Development
  • Metabolic Diseases

Background:

  • Nonalcoholic fatty liver disease (NAFLD) encompasses a range of conditions, potentially progressing to nonalcoholic steatohepatitis (NASH), fibrosis, cirrhosis, and liver cancer.
  • The increasing prevalence of obesity and type 2 diabetes has driven a parallel rise in NASH cases.
  • Significant research efforts are underway to develop effective treatments for NASH due to its high prevalence and severe complications.

Purpose of the Study:

  • To review current drug development for NASH, including mechanisms of action and clinical trial outcomes.
  • To discuss the challenges associated with developing pharmacological therapies for NASH.
  • To provide an overview of the therapeutic landscape for NASH, from early-phase to late-stage development.

Main Methods:

  • Analysis of phase 2A and phase 3 clinical trial data for various NASH drug candidates.
  • Review of scientific literature and regulatory agency requirements for NASH drug approval.
  • Examination of different therapeutic targets and mechanisms of action being investigated for NASH.

Main Results:

  • Early-phase trials (Phase 2A) have explored diverse mechanisms of action across the NAFLD spectrum.
  • Late-phase trials (Phase 3) primarily focus on NASH with fibrosis (stage 2+), utilizing liver histology as a key endpoint.
  • Recent studies show promising results, with the first FDA-approved NASH drug anticipated in 2023, despite prior drug failures.

Conclusions:

  • The development of pharmacological treatments for NASH is progressing, with several promising drug candidates in late-stage trials.
  • Regulatory agencies require robust histological endpoints for phase 3 trials, influencing trial design.
  • Despite challenges, the outlook for NASH pharmacotherapy is improving, offering hope for patients with this progressive liver disease.