Randomization in nQuery Advisor

Because generating randomization lists or schedules is an essential part of most clinical trials, nQuery Advisor offers a menu for the creation of randomization lists for basic, advanced and complex designs. In just a few minutes you can easily specify and obtain a randomization list for your studies. The automated option for mixed block sizes provides assistance in maintaining the double blind.

Click here to view a video tutorial of the randomization features in nQuery Advisor. Or visit our examples section to view both a simple randomization example as well as a more in-depth complex designs example.

Why It’s Important to Use Mixed Block Sizes.

Using mixed block sizes helps maintain the double blind. For example, a common practice is for a multi-center study to use blocks of size four within each center for comparison of a new drug to a placebo. After randomizing three patients the clinician might notice that two patients have the same adverse event (or a particular lab result) which is believed from prior research to be associated with the new drug. If the clinician presumes a block size of four is being used, he or she might suspect that the next person to enter the study will receive the placebo. This suspicion might unconsciously lead to changes in the choice of patient to enter next, perhaps delaying the entry of a particularly ill patient so they have a better chance of receiving the new drug rather than the placebo. Such potential biases in patient entry procedures or in assessment of treatment success based on guesses about the treatment a particular patient is receiving might jeopardize the integrity of the entire trial.

Randomization Options for Complex Designs

“I strongly support your development of this random block generator, as there seems to be a lack of software that will do it and I believe it’s worth doing.”
Senior Research Statistician With Leading CRO

nQuery Advisor® 7.0, developed in conjunction with a leading CRO, introduced a new Complex Designs option which provides:

Expanded Facilities for Specification of Centers and Stratification Factors

• Separate Specification for Centers and Strata
• Easy Specification of proportions for Combined Strata
• Separate Name for each Center and Stratum plus an Additional Center/Strata ID Code

Improved Output Options for the Randomization Lists

• New Treatment ID Code
• Length of Subject ID Number can be edited
• Starting Subject ID Number for each Center/Strata Group can be Specified
• Sequence Numbers
• Date and Time of Day Stamp for Randomization List Creation

Expanded Facilities for Center and Stratification Factor Specification

nQuery Advisor’s New Create Randomization List (Complex Designs) generates clear & detailed output to ensure strict compliance with industry standard randomization techniques.