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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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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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Blinding01:11

Blinding

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Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
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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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Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

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PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...
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Gatekeepers for pragmatic clinical trials.

Danielle M Whicher1, Jennifer E Miller2, Kelly M Dunham3

  • 1Patient-Centered Outcomes Research Institute, Washington, DC, USA dwhicher@pcori.org.

Clinical Trials (London, England)
|September 17, 2015
PubMed
Summary

Implementing pragmatic clinical trials requires navigating resource access. This framework guides gatekeepers, like sponsors and leaders, in making ethical and regulatory-compliant decisions for resource allocation in clinical research.

Keywords:
Gatekeepercomparative effectiveness researchdeliberative democracypragmatic clinical trialresearch ethics

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Area of Science:

  • Clinical Trials
  • Health Services Research
  • Research Administration

Background:

  • Pragmatic clinical trials (PCTs) require substantial resources, including funding, infrastructure, patients, and data.
  • Gatekeepers control access to these essential resources for clinical research implementation.
  • Key gatekeepers in the US include sponsors, regulatory bodies, payers, leadership, and patient advocacy groups.

Purpose of the Study:

  • To present a decision-making framework for gatekeepers involved in resource allocation for pragmatic clinical trials.
  • To outline ethical considerations and regulatory guidance for gatekeepers' decisions.
  • To enhance the legitimacy of gatekeeper decisions through transparency and stakeholder engagement.

Main Methods:

  • Development of a conceptual framework for gatekeeper decision-making.
  • Identification of relevant ethical principles: protecting individuals/communities, advancing organizational goals, and resource stewardship.
  • Application of the framework to various gatekeeper roles within the US clinical research context.

Main Results:

  • The framework integrates ethical considerations (beneficence, organizational mission, stewardship) with regulatory compliance.
  • Transparency and stakeholder engagement are recommended to bolster decision-making legitimacy.
  • Potential conflicts between ethical criteria and regulations are highlighted, impacting resource allocation.

Conclusions:

  • Gatekeepers play a crucial role in facilitating or hindering pragmatic clinical trials through resource management.
  • A structured, ethical, and transparent decision-making process is vital for justifiable resource allocation.
  • Understanding these complex factors enables gatekeepers to make informed choices about valuable research resources.