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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.
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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...

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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.
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Implementation of a Real-Time Psychosis Risk Detection and Alerting System Based on Electronic Health Records using CogStack

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Using real-time alerts for clinical trials: Identifying potential study subjects.

E Chow¹, M Zuberi, R Seto

¹Centre for Innovation in Complex Care , University Health Network.

Applied Clinical Informatics

|April 26, 2013

Summary

This summary is machine-generated.

A mobile real-time alerting system effectively identified potential patients for clinical trials, particularly for time-sensitive influenza studies. This system integrated computerized physician order entry and mobile technology for efficient subject recruitment.

Keywords:

Alerting clinical trials conduct clinical trials recruitment handheld devices messaging

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Area of Science:

Clinical research methodology
Health informatics
Infectious disease epidemiology

Background:

Clinical trials are essential for drug safety and efficacy evaluation.
Patient recruitment is critical for study power, but challenging for seasonal diseases like influenza.
Systematic identification of eligible patients is often difficult in real-time.

Purpose of the Study:

To assess the feasibility of a mobile real-time alerting system for identifying potential subjects.
To evaluate the system's effectiveness in recruiting for a specific influenza clinical trial.
To determine the system's utility for time-sensitive disease research.

Main Methods:

A rules-based alerting system integrated with computerized physician order entry (CPOE) was implemented in a hospital.
Patient identification utilized pharmacy records for antivirals and positive influenza lab results.
Email alerts were sent to study personnel's mobile devices over a 6-month period.

Main Results:

The system generated 779 alerts over 21 weeks, identifying 241 patients.
Of these, 85 were deemed potential study subjects.
The system successfully identified nearly all patients also identified by infection control.

Conclusions:

Integrating CPOE and mobile technology enables real-time identification of potential clinical trial subjects.
This systematic approach is a viable method for hospital-wide patient identification.
The system is particularly beneficial for trials involving time-sensitive disease progression, such as influenza.