Related Experiment Video

Updated: Aug 22, 2026

How to Study Placebo Responses in Motion Sickness with a Rotation Chair Paradigm in Healthy Participants
08:50

How to Study Placebo Responses in Motion Sickness with a Rotation Chair Paradigm in Healthy Participants

Published on: December 14, 2014

The ethical use of placebo in clinical trials involving children

Albert T Derivan1, Bennett L Leventhal, John March

  • 1Pediatric Drug Development, Johnson & Johnson Pharmaceutical Research & Development, Philadelphia, PA, USA. doc@derivan.org

Journal of Child and Adolescent Psychopharmacology
|August 21, 2004
PubMed

Insights

Ethical guidelines for placebo-controlled trials in minors need updating. A multidisciplinary working group should review and expand current pediatric research ethics, focusing on placebo use in drug evaluations.

Area of Science:

  • Pediatric Research Ethics
  • Clinical Trial Design
  • Bioethics

Background:

  • Current ethical guidelines for placebo-controlled trials in minors are insufficient.
  • The American Academy of Pediatrics (AAP) guidelines from 1995 require review.
  • Ethical considerations in pediatric drug studies are complex.

Purpose of the Study:

  • To review existing statements on ethical placebo use in pediatric clinical trials.
  • To propose an expansion of current ethical guidelines.
  • To advocate for an updated framework for placebo-controlled trials in children.

Main Methods:

  • Review of key ethical documents and statements.
  • Analysis of the AAP's "Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations" (1995).
  • Identification of areas for guideline expansion.

Main Results:

  • Existing guidelines for placebo use in pediatric trials need enhancement.
  • A comprehensive review of ethical considerations is necessary.
  • Current frameworks may not fully address the complexities of pediatric placebo-controlled studies.

Conclusions:

  • There is a need to update and expand ethical guidelines for placebo-controlled trials involving minors.
  • A collaborative working group is recommended for this update.
  • Stakeholder involvement is crucial for developing robust pediatric research ethics.

Keywords:
American Academy of PediatricsBiomedical and Behavioral Research

More Related Videos

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition04:53

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

Related Concept Videos

Blinding01:11

Blinding

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.
Blind Procedures02:07

Blind Procedures

Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which child was...
The Placebo Effect01:54

The Placebo Effect

The placebo effect occurs when people's expectations or beliefs influence or determine their experience in a given situation. In other words, simply expecting something to happen can actually make it happen.
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...
Ethics in Research01:56

Ethics in Research

Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
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...