Define the Treatments

In the Treatment(s) section, you can add up to 26 staggered treatment arms with various operational characteristics per plan.

1. On the Treatment tab, in the Treatment(s) section, click Add.

   Note:

   For every treatment you add, the treatment's name defaults to a letter of the alphabet, starting with Treatment A and continuing through Treatment Z. These names are configurable. You can name the treatment to align with what is stated in your specific protocol or to easily distinguish each one.
2. Define the treatment characteristics across the different segments or periods of a trial, including screening, treatment, and follow up to align with the protocol's schedule of assessments or events. For each treatment, specify:
   • Enrolled subjects—Enter the number of subjects enrolling per treatment. If you have a cohort of subjects that are starting treatment before or after this treatment arm, then you can model that as a separate treatment arm.
   • Alternate Subjects—Accept the default value or enter the number of subjects you need to enroll as alternate subjects for Phase I (Healthy Volunteers) plans.
   • FSFT/FPFT Date—Specify the date that the First Subject/ Patient First Treatment (FSFT/FPFT) is expected to take place. ClearTrial estimates this date based on the study site approval schedule. However, you can override the suggested value with any date later than the Project Activity Start Date.
   • Enrollment period—Enter the Enrollment period for late-stage plans. The unit of weeks or days will depend on the value you chose to measure enrollment periods.
   • Enrollment rate—This field displays the average rate at which subjects must be enrolled to meet the specified number of subjects randomized during the specified enrollment period. This value is measured in subjects per site per month.
   • Enrollment distribution—Select the type of enrollment distribution from the ClearTrial-defined enrollment curves available for late-stage plans.
   • LSFT/LPFT Date—This date is when the last subject or patient has their first treatment (intervention) visit post screening.
   • LSLT/LPLT Date—This date is when the last subject or patient has their last treatment visit or data collection event before entering follow-up, if one exists.
   • Cost per bednight—Enter the cost per bednight and the currency to be used, for subjects to stay overnight in the Clinical Pharmacology Unit (CPU) for Phase I (Healthy Volunteers) plans.

   Note:

   Enrollment-specific assumptions are not displayed for Phase I (Healthy Volunteers) plans because enrollment is expected to occur for all subjects in the same day they arrive at the Clinical Pharmacology Unit (CPU).

   Screening

   • Screening period—This is the screening period duration in weeks or days, depending on which value you chose for the Measure treatment duration in assumption.
   • Screening visits per subject—This value represents the number of visits or data collection events that occur per subject during the screening period, as defined in the schedule of assessments in a protocol or study synopsis.
   • CRF Pages per screened subject—This value represents the number of CRF pages collected per screened subject, during the screening period duration defined.
   • Screen failure rate—Enter the percentage of screened subjects expected to fail to become study participants.
   • Number of subjects to screen—This field displays the calculated number of subjects to be screened based on the percentage of subjects that are expected to fail screening and the number of subjects that are expected to be screened.

     The calculation for this field is as follows:

     Number of Screen Failures Expected = Number of Subjects Randomized/Enrolled / ( 100 - Percent of Subjects that Fail Screen )

     For example, if the protocol requires 100 subjects to be randomized, and it is expected that for every four subjects screened, one will fail, this would be a screen failure rate of 25%, yielding the need to screen at least 133 subjects. (133 * 0.25 = 33 screen failures, yielding a total of 100 subjects to randomize).

   Treatment

   • Treatment duration—For each subject, enter the treatment period length in weeks or days, depending on the value you chose for the Measure treatment duration in assumption. For Phase 1 (Healthy Volunteers) trials, the treatment duration is modeled in days. For late-stage trials, the default is weeks but you have the flexibility to model the treatment period in days. ClearTrial allows you to model a minimum of one day or one week for the treatment duration.

     Note:

     If you are modeling more visits to occur in one week for a parallel design trial, for example, if there are eight visits in a one-week treatment duration, ClearTrial recommends that you model the treatment duration in days and then configure the treatment schedule as needed for that treatment arm.

     Note:

     For CRO users, the default treatment period interval unit is in days, with the flexibility to change to weeks, as needed.
   • Visits per subject—Specify the number of visits or data collection events for each subject during the treatment period. For Phase 1 (Healthy Volunteers) trials, because you are modeling in days, a visit is assumed to be on the day of treatment. A visit is a day for which one or more CRF pages or data are generated and collected. If you are modeling a trial in which patients are seen more than once per week, and still want to model the duration in weeks, add the number of pages collected at each of the visits into a single visit in the treatment schedule.

     For Phase 1 (Healthy Volunteers) studies, in which subjects are confined and procedures are performed throughout the day on most or all days of treatment or washout, each day is a visit for the purposes of the ClearTrial costing algorithms.

     If your study has multiple visits per week, specify the duration of the treatment period in days. This allows CRO users to enter the actual number of visits so that the bid matches the RFP. Otherwise, visits occurring in the same week should be combined into a single visit. If the number of visits is greater than the number of weeks, you will see a warning.

     ClearTrial recommends planning in days, and not weeks, for these scenarios.

   • Number of bednights—For Phase 1 (Healthy Volunteers) trials, specify the number of nights subjects will be confined to the CPU during the treatment period duration. ClearTrial uses this value to calculate pass-through costs associated with non-procedural services provided (for example, room, meals, and entertainment). If subjects are also confined during the washout period(s), you have the flexibility to specify the number of bednights during washout separately.
   • CRF pages per subject—Specify the total number of Case Report Form (CRF) pages estimated to be collected for each subject during treatment. This value should include quality-of-life (QOL), pharmacoeconomic, and subject diary pages collected.
   • Number of cycles—Specify the number of cycles or the number of times subjects will repeat this treatment before follow-up, as specified in the protocol.

   • Subject diary pages—Specify how many of the pages collected during the treatment period are subject diary pages.

   • QOL Pages—Specify how many of the pages collected during the treatment period are Quality of Life (QOL) pages.
   • Pharmacoeconomic pages—Specify how many of the pages collected during the treatment period are pharmacoeconomic pages.
   • Subject drop rate—Specify the percent of subjects expected to drop during the treatment period.

     ClearTrial uses this percentage as it calculates the data that needs to be monitored during treatment. For example, if you expect only three out of four subjects randomized to complete the treatment period, the treatment period's subject drop rate is 25%. If 100 subjects are randomized and you expect a 25% drop rate during treatment, only 75 subjects are expected to complete treatment.

   • Lab/Diagnostic tests/subject—Specify the number of expected lab and diagnostic tests per subject per treatment arm. This field is only available in late-stage trials for cost model versions 5.5 and above. This assumption value drives the effort for the ClearTrial-defined task, Review alert lab and diagnostic test results.
   • Cohort escalation reviews—Specify the number of dose escalation reviews per treatment arm. This field is only available for late-stage plans and in cost model versions 5.5 and above. This assumption's value drives the effort for the ClearTrial-defined task, Review data to determine dose escalation.
   • Monitoring minutes per page—Specify the number of minutes to monitor one standard CRF page (excluding eDiary, QOL, and Pharmacoeconomic pages). If a study is complex, or you want the monitors to spend extra time performing additional activities, increase this assumption's default value. ClearTrial calculates the default value based on the study phase, therapeutic area, and indication.

   Follow-Up

   • Follow subjects for—Specify the follow-up period duration in years, weeks, or days.
   • % completed subjects followed—Specify what percentage of subjects who completed treatment will enter the follow-up period.
   • First follow-up occurs after—Specify when the first follow-up visit or data collection event occurs after the Last Subject/Patient Last Treatment visit, as defined in the protocol's schedule of events or assessments.
   • Follow-up visits occur every—Specify how often visits occur or the frequency of visits where data is generated during the follow-up period.
   • Follow-up drop rate—Specify the estimated drop date for subjects in the follow-up period.
   • CRF pages per follow-up visit—Specify the number of CRF pages collected per visit during the follow-up period.
   • Subject diary pages per visit—Specify the number of subject diary pages collected per visit during the follow-up period.
   • QOL pages per visit—Specify the number of Quality of Life (QOL) pages collected per visit during the follow-up period.
   • Pharmacoeconomic pages per visit—Specify the number of pharmacoeconomic pages collected per visit during the follow-up period.
   • LSLV/LPLV Date—This is the last subject or patient last visit or last subject or last patient follow-up visit.

3. Select a treatment arm and click Edit to define all location-specific assumptions around subjects, enrollment, screening, treatment, follow-up, and grants/stipend amounts.

   Note:

   When you have overrides by location, such as FSFT, that exist in a plan for modeling when sites and subjects are coming on later, if you toggle to override at the global treatment arm level, then the global treatment level updates will be used downstream.

   • Subjects—Manage FSFT/FPFT or the enrollment period by location or by treatment, or to override their default assumption values.

     Note:

     When you have multiple locations in a plan and treatment arms have sites and subjects expected to be approved and enrolled later, then for those location with zero subjects, select FSFT by location and adjust the FSFT date per location.
   • Enrollment—Specify enrollment distribution values by location or by treatment. If you manage by location, select the specific plan location to view the number of subjects and the percentage of total subjects allocated, per period.

     Select the enrollment distribution from one of the default ClearTrial-defined enrollment distribution curves or select Custom to customize your own.

   • Screening—Review all screening period-specific assumptions and override default values, if needed. You can also manage the screen failure rate by location.
   • Treatment—Review all treatment period-specific assumptions and override them, if needed. You can also manage the subject drop rate during the treatment period by location.
   • Follow-Up—Review all follow-up period-specific assumptions and override any if needed. You can also manage the follow-up subject drop rate or the percent of subjects not expected to complete the follow-up period, by location.
   • Schedule—Review the entire trial's subject visit schedule across Screening, Treatment, and Follow-Up periods. Specify how much data is to be collected per period, the monitoring time in minutes, and the percent of the grant distributed for treatment and follow-up periods. If you have cycles defined, you can review those as well.

     Note:

     The number of weeks or days displayed in the subject visit schedule is configurable and can be updated to display more data on one screen without having to go to the next page. You can override the default customer configuration that impacts all plans by asking your assigned System Administrator to change the setting using Customer Preferences launched by either selecting Preferences from the Maintain menu or by selecting Customer Preferences from the Admin menu.
   • Grants—Specify grant/stipend amount details by location.
   • Notes—Enter in any information you want to capture or track per treatment arm.
4. Click Next to specify data management assumptions.