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Run simulation for dynamic randomization

In IWRS, once you configure the dynamic randomization scheme and generate an arm selector, you can run the simulation to assess the capabilities and efficiency of the implemented configs for your study needs and requirements.

To run a dynamic randomization simulation

  1. In the IWRS application header, select the TREATMENT DESIGN tab.

  2. In the left pane of the page that opens, select Period.

  3. In the Period List table that appears, select the period within which you want to run a dynamic randomization scheme simulation.

    Selecting period to configure
    Figure 1. Selecting period to configure

  4. In the period configurator tree, drill down and expand the cohort for which the dynamic randomization method is configured. From the expanded cohort menu, select Randomization List.

  5. In the Randomization List table that appears, locate the randomization scheme for which you want to run a simulation and select its name.

    Accessing randomization scheme configurator
    Figure 2. Accessing randomization scheme configurator

    Tip

    You can also select the Scheme node under the respective randomization scheme in the period configurator tree.

    Accessing randomization scheme configurator from tree
    Figure 3. Accessing randomization scheme configurator from tree

  6. On the page that opens, select the Arm Allocation Options tab.

  7. On the resulting Arm Allocation Options page, select simulate_button.png to run a dynamic randomization simulation.

  8. On the Simulation List page that opens, select New Item add_new_icon.png.

    Adding new simulation
    Figure 4. Adding new simulation

    Tip

    You can skip adding a new simulation if you already have the list of previously configured ones and want to run one of them. In this case, go to step 10.

  9. In the New dialog that appears, complete the fields as explained in the following table.

    Configuring new simulation
    Figure 5. Configuring new simulation

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Name*

    Enter the name for your simulation configuration.

    # of Simulation Run*

    Enter the number of how many times you want to run this simulation to compare various possible results.

    For instance, if you enter 5, the system runs the simulation five times and you can view five different results to have more understanding of how this configuration might work out for you.

    # of Subjects*

    Enter the number of subjects that are randomized with this simulation. It is recommended to add the number that is close to your real-case cohort size to get the simulation result as close as possible to reality.

    # of Sites*

    Enter the number of sites between which the subject are allocated with this simulation. It is recommended to add the number that is close to your real-case scenario to get the simulation result as close as possible to reality.

    Strata Ratio*

    Enter the the number to outline the ratio of subjects allocated to each strata factor compared to others within this simulation.

    For instance, if the ratio of all factors is 1, the system gives them equal consideration.. However, if one factor has a ratio of 2, and the other factors have a ratio of 1, then the with a higher ratio has more influence on the subject allocation probability.

    SAVE

    Select save_button_red.png to implement the changes, close the dialog, and return to the Simulation List page.

    CANCEL

    Select cancel_button_white_blue.png to discard all changes without saving, close the dialog, and return to the Simulation List page.

  10. On the Simulation List page that opens, locate the simulation that you want to initiate and from the Action(s) column next to it, select Run run_icon.png.

    Tip

    You can update the simulation configuration if it is not run yet. Simply select Edit pencil_icon.png and make changes as explained in the previous table.

    Running simulation
    Figure 6. Running simulation

You have successfully run the dynamic randomization simulation. You can now view the simulation result.

In this section:

A randomization method that adjusts the allocation probabilities based on the current distribution of participants. Thus, when each subject comes to the study, the system assesses their compliance with established factors, evaluates the existing patient groups and site imbalance, and allocates the new patient to the most imbalanced group. Unlike permuted block randomization, dynamic randomization does not involve the predefined randomization list and offers more adaptivity to achieve arm balance at all times.

A component of the dynamic randomization algorithm that determines the treatment arm to which a new participant is allocated based on certain predefined criteria or rules.