Related Experiment Video
Updated: Jun 28, 2026
04:53
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Clinical trials subject registration and randomization system (SRAR)
1Moffitt Cancer Center, Tampa, FL, USA.
AMIA ... Annual Symposium Proceedings. AMIA Symposium
|November 13, 2008
Summary
This study introduces a web-based application for clinical trial subject randomization. It programmatically determines patient eligibility and stratum assignment, enhancing multi-institutional data accrual and secure access for cancer research.
Area of Science:
- Oncology
- Clinical Research
- Biostatistics
Background:
- Clinical trials require random treatment assignment for subjects.
- Stratified randomization, based on patient factors, is common in trial protocols.
- Accurate stratum determination is crucial for unbiased trial outcomes.
Purpose of the Study:
- To develop a programmatic application for determining subject eligibility and stratum assignment in clinical trials.
- To facilitate secure, multi-institutional subject registration and randomization via the web.
- To enable blinded distribution of treatment results via email.
Main Methods:
- Development of a web-based application utilizing Open-Source technologies.
- Implementation of programmatic logic for eligibility and stratum determination.
- Secure access protocols for multi-institutional collaboration and data entry.
- Automated email distribution of treatment assignments with blinded recipients.
Main Results:
- Successful implementation of a system for automated, programmatic stratum assignment.
- Enabled secure, web-based multi-institutional subject registration and randomization.
- Facilitated blinded dissemination of treatment allocation information.
Conclusions:
- The developed application streamlines the complex process of stratified randomization in cancer clinical trials.
- It enhances data integrity and security in multi-institutional research settings.
- Open-Source technology provides a flexible and accessible platform for clinical trial management.
Related Concept Videos
01:13Randomized Experiments
The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...
Simple randomization
Simple...
01:11Blinding
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.
01:16Clinical 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...
There are four phases in a clinical trial. A phase one...
01:11Clinical 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...
01:20Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs
Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to subjects...
01:15Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs
Bioequivalence experimental study designs play a pivotal role in testing the effectiveness of various treatments. Key among these are the repeated measures, cross-over, carry-over, and Latin square designs. In the repeated measures design, each subject receives all treatments, allowing for temporal comparisons. This type of design is useful in reducing variability but requires careful planning to avoid bias.The cross-over design, an economical method, involves sequential administration of...