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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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Bioequivalence studies: Biowaivers01:13

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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...
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Implementing two-stage consent pathway in neonatal trials.

Eleanor Mitchell1, Sam J Oddie2, Jon Dorling3

  • 1Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK eleanor.mitchell@nottingham.ac.uk.

Archives of Disease in Childhood. Fetal and Neonatal Edition
|December 24, 2021
PubMed
Summary
This summary is machine-generated.

Rapid recruitment in perinatal trials is crucial for time-sensitive interventions. A two-stage consent process, involving oral assent followed by written consent, is being implemented in the fluids exclusively enteral from day one (FEED1) trial to address this need.

Keywords:
ethicsintensive care unitsneonatalneonatology

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Area of Science:

  • Neonatal research
  • Clinical trial methodology
  • Informed consent procedures

Background:

  • Perinatal clinical trials often necessitate rapid participant recruitment for time-critical interventions.
  • A two-stage consent pathway, involving initial oral assent and subsequent written informed consent, is supported by national guidance for such trials.
  • Apprehension exists regarding the oral assent component due to concerns about record-keeping, information standardization, and process familiarity.

Purpose of the Study:

  • To describe the implementation of a two-stage consent pathway in the fluids exclusively enteral from day one (FEED1) trial.
  • To outline the support provided to trial sites by the FEED1 trial team.
  • To offer recommendations for future trials considering a similar consent pathway.

Main Methods:

  • The FEED1 trial utilizes a two-stage consent process, requiring randomization within 3 hours of birth.
  • Trial sites were provided with specific support measures to facilitate the implementation of the oral assent pathway.
  • The study describes the practical application and challenges encountered during the oral assent phase.

Main Results:

  • The FEED1 trial has implemented a two-stage consent pathway to enable rapid recruitment for time-critical interventions.
  • Specific strategies were employed to support clinical sites in managing the oral assent process.
  • Apprehensions regarding the oral assent pathway were identified, mirroring previous research findings.

Conclusions:

  • The two-stage consent pathway, including oral assent, is a viable method for rapid recruitment in time-critical perinatal trials like FEED1.
  • Proactive support and clear guidelines are essential for successful implementation of oral assent procedures.
  • Recommendations are provided to assist future research endeavors in adopting similar consent strategies.