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Related Concept Videos

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...
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...
Preparation of Diols and Pinacol Rearrangement01:57

Preparation of Diols and Pinacol Rearrangement

Compounds bearing two hydroxyl groups are known as diols. When the hydroxyl groups are located on adjacent carbon atoms, the diols are called vicinal diols or glycols. Under acidic conditions, vicinal diols undergo a specific reaction called pinacol rearrangement.
The reaction begins with transferring a proton from the acid catalyst to one of the hydroxyl groups, producing an oxonium ion.

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A Proboscis Extension Response Protocol for Investigating Behavioral Plasticity in Insects: Application to Basic, Biomedical, and Agricultural Research
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Postregistration trials: should we? How do we?

Lorenzo Del Sorbo1, B Taylor Thompson, V Marco Ranieri

  • 1Dipartimento di Anestesiologia e Rianimazione, Università di Torino, Ospedale S. Giovanni Battista-Molinette, Torino, Italy.

Critical Care Medicine
|December 24, 2008
PubMed
Summary
This summary is machine-generated.

Postregistration trials evaluate approved treatments for effectiveness and rare side effects. Ethical challenges include reporting bias and placebo use when proven treatments exist, particularly for recombinant human activated protein C in sepsis.

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Area of Science:

  • Clinical Trials
  • Pharmacovigilance
  • Medical Ethics

Background:

  • Postregistration (Phase IV) trials assess approved treatments for effectiveness, rare side effects, and new indications.
  • Ethical considerations in postmarketing surveillance are crucial for drug safety and efficacy evaluation.
  • The use of placebo in trials with existing treatments presents significant ethical dilemmas.

Purpose of the Study:

  • To examine ethical challenges in postregistration trials, focusing on reporting bias and placebo use.
  • To discuss the relevance of these ethical issues in critical care, specifically concerning recombinant human activated protein C (rhAPC).
  • To review the ongoing debate surrounding placebo-controlled studies for rhAPC in severe sepsis.

Main Methods:

  • Literature review and ethical analysis of postregistration trial methodologies.
  • Case study analysis focusing on recombinant human activated protein C (rhAPC) in severe sepsis.
  • Examination of regulatory perspectives, including the European Medicines Agency's stance on rhAPC trials.

Main Results:

  • Industry-sponsored research may introduce reporting bias, affecting true treatment effectiveness.
  • The use of placebos in trials where effective treatments exist raises ethical concerns regarding patient welfare.
  • The European Medicines Agency has requested further placebo-controlled studies for rhAPC due to unresolved efficacy and safety questions.

Conclusions:

  • Ethical scrutiny of postregistration trials is vital, particularly concerning reporting bias and placebo use.
  • The case of rhAPC highlights the complexities of balancing established treatments with the need for rigorous evidence generation.
  • Further research and ethical deliberation are required to optimize postmarketing surveillance and ensure patient safety.