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Related Concept Videos

Clinical Trials01:16

Clinical Trials

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...
Clinical Trials: Overview01:11

Clinical Trials: Overview

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...
Preclinical Development: Overview01:28

Preclinical Development: Overview

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

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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

Bioavailability Study Design: Healthy Subjects Versus Patients

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,...
Dosage Regimens: Designs and Approaches01:28

Dosage Regimens: Designs and Approaches

Designing a dosage regimen, which refers to the manner of drug administration, is a complex process involving the selection of drug dose, route, and frequency. This process is underpinned by pharmacokinetic parameters derived from tests and population averages. These parameters are then tailored to patient-specific variables such as diagnosis, demographics, and allergy status. Once therapy commences, therapeutic response monitoring is critical and achieved through clinical and physical...

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Involving Individuals with Developmental Language Disorder and Their Parents/Carers in Research Priority Setting
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Involving Individuals with Developmental Language Disorder and Their Parents/Carers in Research Priority Setting

Published on: June 6, 2020

Developing a guideline for clinical trial protocol content: Delphi consensus survey.

Jennifer Marie Tetzlaff1, David Moher, An-Wen Chan

  • 1Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada. jtetzlaff@ohri.ca

Trials
|September 26, 2012
PubMed
Summary
This summary is machine-generated.

Experts reached consensus on essential content for randomized clinical trial (RCT) protocols using a Delphi survey. This work guides the development of standardized RCT protocol guidelines.

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Area of Science:

  • Clinical Trials
  • Research Methodology
  • Health Sciences

Background:

  • Clinical trial protocols often exhibit deficiencies impacting various stakeholders.
  • Existing guidelines for randomized clinical trial (RCT) protocol content lack standardization and systematic development methods.
  • This study is a key step in developing a comprehensive guideline for RCT protocol content.

Purpose of the Study:

  • To develop and refine minimum content requirements for randomized clinical trial (RCT) protocols.
  • To establish a consensus on essential items for RCT protocols through a systematic process.
  • To inform the creation of a standardized guideline for clinical trial protocol development.

Main Methods:

  • A three-round Delphi consensus survey was employed.
  • Expert panellists (n=96) from diverse stakeholder groups were recruited iteratively.
  • Panellists rated the importance of protocol content items, with consensus levels analyzed.

Main Results:

  • Sixty-three of 88 concepts were rated as highly important for minimum RCT protocol content.
  • Fifty concepts achieved a high importance rating (25th percentile ≥ 8).
  • Moderate and low importance items were also identified, providing nuanced insights.

Conclusions:

  • A diverse panel of experts achieved consensus on essential RCT protocol content.
  • The Delphi process identified areas of agreement and divergence in protocol requirements.
  • Findings will contribute to developing a robust guideline for clinical trial protocol content.