Taimei's IWRS System Meets Increasingly Common and Complex Blind Designs

Background

Blinding is an important measure to control trial bias in clinical trials, and blindness maintenance is also the most basic requirement for randomized systems. However, in a trial, different stages and different drugs may have different blinding requirements. If the system only follows the fully blinded design regardless of the different requirements of the experimental program is not the best practice. At present, the number of blind projects implemented by Taimei Technology accounts for about 80% of the total, and more open trials are also being built according to the blind settings of the blind trials.

In addition to the conventional blind control, the randomization and drug supply management system of Taimei Technology eBalance (IWRS) can distinguish blind and unblinded subjects, blind and unblinded drugs, and blind and unblinded personnel in terms of configuration, execution, and reporting according to the requirements of the protocol, so as to maintain the blindness to the greatest extent and better manage the project.

eBalance

Case 1

The subjects of a psoriasis project were randomized to enter the 16-week double-blind treatment period and use double-blind drugs. After completion, all subjects entered the open treatment period and used open drugs.

Solution

In blind trials, drugs can also be set with different blind properties. For blind drugs, a systematic supply plan is used, and the system automatically triggers the shipping order for blind drugs. The open drugs will be applied by site CRA according to the site’s actual needs, and the system will also provide drug use predictions, which reduces the waste by 10~20% compared with the traditional drug application and delivery methods.

Case 2

In a phase I clinical study of single multiple administration, dose escalation and food effect, it is divided into a double-blind single dosing phase, a double-blind multiple dosing phase, and an open food effect phase. The double-blind trials require subjects to be randomized and drug dosed, and the open trial only requires subjects to be randomized.

Solution

Three cohorts are set up, and different cohorts can be set to be blinded or not, and the subject groups can be directly viewed after randomization of open trials. Compared with the traditional database building method, which needs to create three independent databases, it greatly saves the cost of building database and system use.

Case 3

In a randomized, blinded phase III clinical trial to observe the efficacy and safety of subjects with acute ischemic stroke, the control group used normal saline in the hospital, so the operating nurse could not be blinded.

Solution

Set up an unblinded study nurse, the blinded investigator is responsible for the randomization. After randomization, only the unblinded study nurse can view the subject group to determine the dosing protocol. Study nurse can get the randomized results immediately after the randomization, and arrange the drug dosing immediately, which is very convenient.

 

 

 

 

Summary

eBalance screen

IWRS systems require sophisticated blinding techniques without project-based code programming, which increases the risk of blinding and code quality control.

Taimei’s eBalance is designed to maintain the blind state in randomization and drug supply management at the same time, and the blind field is checked throughout the process of system development and verification to ensure that the privacy of the blind field data is effectively controlled. Since the blind state holding function was launched, there has never been an accidental system blind breaking event, which greatly improves the safety and reliability of the system.

In addition to the conventional blind control, the randomization and drug supply management system of Taimei Technology eBalance (IWRS) can distinguish blind and unblinded subjects, blind and unblinded drugs, and blind and unblinded personnel in terms of configuration, execution, and reporting according to the requirements of the protocol, so as to maintain the blindness to the greatest extent and better manage the project.