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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...

Preclinical Development: Overview

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...

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...

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...

Bioequivalence of Drugs: Drugs with Multiple Indications

Bioequivalence of Drugs: Drugs with Multiple Indications

The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each indication due to...

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Related Experiment Video

Updated: Jul 11, 2026

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

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

Published on: September 20, 2019

Clinical trials: bridging the gap between efficacy and effectiveness.

Colin Depp¹, Barry D Lebowitz

¹Sam and Rose Stein Institute for Research on Aging, University of California, San Diego, California 92161, USA.

International Review of Psychiatry (Abingdon, England)

|September 27, 2007

Summary

Clinical psychiatry research is evolving beyond traditional efficacy trials to effectiveness trials. These public-health focused studies provide more practical information for patients and clinicians in real-world settings.

Related Experiment Videos

Last Updated: Jul 11, 2026

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

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

Published on: September 20, 2019

Area of Science:

Psychiatry
Clinical Trials
Public Health

Background:

Traditional efficacy trials in clinical psychiatry have limitations in providing practical information to diverse stakeholders.
The development of new clinical trial approaches is crucial for advancing psychiatric research.
Effectiveness or public-health models offer a more practical approach to intervention research.

Purpose of the Study:

To review the principles and practical considerations of efficacy-oriented trials in psychiatry.
To explore the shift towards effectiveness-oriented trials in psychiatric research.
To highlight the impact and challenges of public-health oriented trials in psychiatry.

Main Methods:

Review of existing literature on clinical trial methodologies in psychiatry.
Analysis of principles underlying efficacy and effectiveness trial designs.
Discussion of practical considerations for implementing public-health focused psychiatric trials.

Main Results:

Efficacy trials, while foundational, often fall short in delivering actionable insights for real-world practice.
Effectiveness trials, targeting diverse patient groups in varied settings, yield more clinically meaningful information.
NIMH-funded trials in schizophrenia, Alzheimer's disease, depression, and bipolar disorder demonstrate the impact of this model.

Conclusions:

Effectiveness-oriented trials represent a significant advancement in psychiatric research, offering practical insights.
Public-health focused trials are essential for addressing the needs of diverse patient populations in real-world settings.
Understanding the principles and challenges of effectiveness trials is key for future psychiatric research and clinical practice.