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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

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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...

Drug Discovery: Overview

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Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...

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.
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Structure-Activity Relationships and Drug Design

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Related Experiment Video

Updated: Jul 15, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

Design, simulate, refine: simulation-guided clinical trials for accelerated drug development.

Elias Laurin Meyer^1,2, Tim Friede^3,4,5, Andrew P Grieve^6,7

¹Berry Consultants, Vienna, Austria. elias@berryconsultants.com.

Nature Reviews. Drug Discovery

|July 13, 2026

Summary

Simulation-guided design enhances complex clinical trials by optimizing research questions and improving communication. This approach helps refine trial designs for scientific rigor, ethical soundness, and efficient delivery of therapies.

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In Silico Clinical Trials for Cardiovascular Disease

In Silico Clinical Trials for Cardiovascular Disease

Published on: May 27, 2022

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Last Updated: Jul 15, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

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Published on: December 11, 2016

In Silico Clinical Trials for Cardiovascular Disease

In Silico Clinical Trials for Cardiovascular Disease

Published on: May 27, 2022

Area of Science:

Clinical trial methodology
Biostatistics
Drug development

Background:

Modern clinical trials increasingly use complex strategies like adaptive designs and master protocols.
These innovative approaches accelerate discovery but add complexity to study conduct and design comprehension.

Purpose of the Study:

To highlight simulation-guided design as a tool for optimizing complex clinical trial designs.
To explain how simulations aid in understanding and communicating trial operational characteristics and potential risks.

Main Methods:

Utilizing simulations to evaluate operating characteristics of complex trials.
Assessing type I error, false discovery rate, power, and adaptive decision probabilities.
Examining individual simulated trials to understand practical performance.

Main Results:

Simulation-guided design aids in identifying optimal trial designs tailored to research questions.
Simulations provide insights into trial performance, enabling anticipation and mitigation of risks.
This approach enhances cross-functional communication and justifies design choices.

Conclusions:

Simulation-guided design empowers diverse stakeholders in clinical development.
It fosters scientifically rigorous, ethically sound, and operationally practical trial designs.
Ultimately, simulation facilitates the efficient delivery of safe and effective therapies to patients.