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Clinical Trials

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: Overview

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...

Blind Procedures

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...

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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...

Blinding

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.

Bioequivalence studies: Biowaivers

Bioequivalence studies: Biowaivers

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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Related Experiment Video

Updated: Jul 1, 2026

In Silico Clinical Trials for Cardiovascular Disease

In Silico Clinical Trials for Cardiovascular Disease

Published on: May 27, 2022

Industry-sponsored ghostwriting in clinical trial reporting: a case study.

Leemon B McHenry¹, Jon N Jureidini

¹Department of Philosophy, California State University, Northridge, California 91330, USA. leemon.mchenry@csun.edu

Accountability in Research

|September 17, 2008

Summary

Ghostwriting clinical trial results, like Study 329 for paroxetine, can manipulate data. This case study reveals how a ghostwritten publication misrepresented negative findings as positive, influencing medical practice.

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Published on: September 20, 2019

Area of Science:

Medical ethics
Pharmaceutical industry practices
Clinical trial reporting

Background:

Clinical trial data integrity is crucial for patient safety and effective treatment.
Publication bias and ghostwriting can distort the scientific record.
Study 329 investigated the efficacy and safety of paroxetine in pediatric patients.

Purpose of the Study:

To examine the impact of ghostwriting on the interpretation and dissemination of clinical trial results.
To analyze how Study 329's findings were misrepresented in its publication.
To illustrate the influence of sponsor-controlled messaging in medical literature.

Main Methods:

Case study analysis of litigation documents related to Study 329.
Comparison of original study data with the published manuscript.
Examination of author contributions and sponsor influence on the publication.

Main Results:

Study 329 demonstrated negative efficacy and positive harm for paroxetine in pediatric use.
The ghostwritten publication falsely concluded paroxetine was effective and safe.
Despite revisions, the sponsor maintained control over the publication's core message.

Conclusions:

Ghostwriting can significantly manipulate clinical trial data to favor specific medications.
Misrepresentation of study findings poses risks to patient care and public health.
Transparency and accountability in clinical trial publication are essential to prevent data manipulation.