11 Treatment Tab

The Treatment Tab allows you to add, edit, copy, and delete one or more treatments within a plan.

Using the fields on this tab, you can model single or multiple treatment arm trials, using either parallel or cross-over designs. For late stage parallel design trials you can also model endpoint studies.

Trial Design

The Treatment Tab allows you specify whether this study uses a parallel or cross-over design with the Trial Design field.

Parallel designs are those in which some subjects receive only one of the defined treatments, while other subjects receive only one of the other defined treatments and these subjects receive treatments during the same period.

Cross-over designs are those in which each subject receives all defined treatments, but in a different order or sequence.

Cross-over designs are more common than Phase I trials, but can be used for some later stage trials as well. Cross-over designs are generally used to reduce the number of subjects required to obtain statistically valid results. When subjects act as their own controls, variability based on age, gender, ethnicity, and lifestyle, for example, is eliminated.

Adding Treatments

The Treatment Tab allows you to add treatments for Parallel or Cross-over trials.

Adding Treatments for Parallel Trial Design Studies - Phase I Healthy Volunteers

Treatments can be added to phase I healthy volunteer studies with a parallel trial design.

To add one or more treatments:

1. Navigate to the Treatments Tab.

2. In the Trial Design field, select Parallel.

3. In the Electronic subject diary field, select yes or no.

   This field allows you to indicate whether an electronic subject diary is to be expected.

4. In the Cost per bednight field, enter the cost per bednight.

5. Click the Add button.

   Another treatment will be added to the list of treatments.

6. In the Number of subjects field, enter the number of subjects that will receive the treatment.

7. In the Treatment Duration field, enter the treatment length for each subject. The duration is specified in weeks for late stage trials and in days for Phase 1 trials.

8. In the Visits per subject field, specify the number of visits for each subject during the treatment.

   A visit is a week (late stage) or day (Phase 1) in which one or more CRF pages are collected.

   For Phase 1 Healthy Volunteers trials in which subjects are confined and procedures are performed throughout the day on most or all days of treatment and/or washout, each day would be considered a visit.

9. In the Number of Bednights field, enter the number of nights study subjects will stay on site.

10. In the Number of CRF pages per subject field, enter the number of Case Report Form (CRF) pages that will be collected for each subject during this treatment.

    This value should be inclusive of quality-of-life (QOL), pharmacoeconomic, and subject diary pages collected.

11. In the Number of QOL pages field, enter how many Quality of Life (QOL) pages will be collected during the treatment period.

    QOL pages are reviewed to see if they have been filled out by the study subjects, but usually require little or no monitoring.

12. In the Number of Subject Diary Pages field, enter how many subject diary pages will be collected during the treatment period.

13. In the Number of Pharmacoeconomic pages field, enter the number of pharmacoeconomic pages that will be collected during the treatment period.

    These pages are reviewed to see if they have been filled out by the study subjects, but usually require little or no monitoring.

14. Click the Save button. Click the Add button to add more treatments or Next to continue to the next plan tab.

Adding Treatments for Parallel Trial Design Studies - Late Stage and Phase I Oncology/Vaccine

Treatments can be added to phase II through IV studies and phase I oncology/vaccines studies with a parallel trial design.

To add one or more treatments:

1. Navigate to the Treatments Tab.

2. In the Trial Design field, select Parallel.

3. In the Electronic subject diary field, select yes or no.

   This field allows you to indicate whether an electronic subject diary is to be expected.

4. In the Endpoint Study field, select yes or no.

   The Endpoint Study field is only available for phase II through IV studies and phase I oncology/vaccine studies. This field allows you to indicate whether the study being modeled is an endpoint study.

   In ClearTrial, an endpoint study is a study in which all patients conclude their participation in the study on, or around, the same calendar date.

5. Click the Add button.

   Another treatment will be added to the list of treatments.

6. In the Number of subjects field, enter the number of subjects that will receive the treatment.

7. In the Treatment Duration field, enter the treatment length for each subject. The duration is specified in weeks for late stage trials and in days for Phase 1 trials.

8. In the Visits per subject field, specify the number of visits for each subject during the treatment.

   A visit is a week (late stage) or day (Phase 1) in which one or more CRF pages are collected.

   For Phase 1 Healthy Volunteers trials in which subjects are confined and procedures are performed throughout the day on most or all days of treatment and/or washout, each day would be considered a visit.

9. In the Number of CRF pages per subject field, enter the number of Case Report Form (CRF) pages that will be collected for each subject during this treatment.

   This value should be inclusive of quality-of-life (QOL), pharmacoeconomic, and subject diary pages collected.

10. In the Number of QOL pages field, enter how many Quality of Life (QOL) pages will be collected during the treatment period.

    QOL pages are reviewed to see if they have been filled out by the study subjects, but usually require little or no monitoring.

11. In the Number of Subject Diary Pages field, enter how many subject diary pages will be collected during the treatment period.

12. In the Number of Pharmacoeconomic pages field, enter the number of pharmacoeconomic pages that will be collected during the treatment period.

    These pages are reviewed to see if they have been filled out by the study subjects, but usually require little or no monitoring.

13. Click the Save button. Click the Add button to add more treatments or Next to continue to the next plan tab.

Adding Treatments for Cross-Over Trial Design Studies - Phase I Healthy Volunteers

Treatments can be added to phase I healthy volunteer studies with a cross-over trial design.

To add one or more treatments:

1. Navigate to the Treatments Tab.

2. In the Trial Design field, select Cross-over.

   The available fields displayed will pertain to cross-over trial design studies.

3. In the Electronic subject diary field, select yes or no.

   This field allows you to indicate whether an electronic subject diary is to be expected.

4. In the Cost per bednight field, enter the cost per bednight.

5. In the Number of CRF pages collected in the baseline visit field, enter the number of CRF pages that are to be collected during the screening and baseline visits.

   The value entered in this field should be the total number of CRF pages collected for enrolled subjects during their screening visits and during the baseline visit. Only enter the number of pages that are collected at the beginning of the study, not the number collected at the beginning of each treatment period.

   Note:

   The pages collected for candidates that do not pass screening is a value captured on the Subject tab.

6. The Baseline visit monitoring time required (in minutes) field displays the number of minutes required to monitor pages collected during the screening and baseline visit(s). The value displayed can be overridden.

7. In the Washout period duration field, enter the length of the washout period.

   The duration is specified in weeks for late stage trials and in days for Phase 1 trials.

   The washout period is the time between treatments in a cross-over trial in which subjects are not treated in an effort to reduce or avoid residual effects of the prior treatment from skewing the data or compromising the validity of the subsequent treatment(s).

   If data are collected during the washout period, you will need to configure that by clicking the link labeled, "Configure washout period."

8. In the Treatment Duration field, enter the treatment length for each subject. The duration is specified in weeks for late state trials and in days for Phase 1 trials.

9. In the Visits per subject field, specify the number of visits for each subject during the treatment.

   A visit is a week (late stage) or day (Phase 1) in which one or more CRF pages are collected.

   For Phase 1 Healthy Volunteers trials in which subjects are confined and procedures are performed throughout the day on most or all days of treatment and/or washout, each day would be considered a visit.

10. In the Number of bednights field, enter the number of nights study subjects will stay on site.

11. In the Number of CRF pages per subject field, enter the number of Case Report Form (CRF) pages that will be collected for each subject during this treatment.

    This value should be inclusive of quality-of-life (QOL), pharmacoeconomic, and subject diary pages collected.

12. In the Number of QOL pages field, enter how many Quality of Life (QOL) pages will be collected during the treatment period.

    QOL pages are reviewed to see if they have been filled out by the study subjects, but usually require little or no monitoring

13. In the Number of Subject Diary Pages field, enter how many subject diary pages will be collected during the treatment period.

14. In the Number of Pharmacoeconomic pages field, enter the number of pharmacoeconomic pages that will be collected during the treatment period.

    These pages are reviewed to see if they have been filled out by the study subjects, but usually require little or no monitoring.

15. Click the Save button. Click the Add button to add more treatments to study.

16. In the Cross-Over Design field, select a cross-over design to determine the specific sequences of treatments to which subjects will be randomized.

    ClearTrial currently supports either Latin Square or Balaam's Design. Balaam's Design is only applicable to a trial with two treatments.

17. Click Save.

Adding Treatments for Cross-Over Trial Design Studies - Late Stage and Phase I Oncology/Vaccine

Treatments can be added to phase II through IV studies and phase I oncology/vaccine studies with a cross-over trial design.

To add one or more treatments:

1. Navigate to the Treatments Tab.

2. In the Trial Design field, select Cross-over.

   The available fields displayed will pertain to cross-over trial design studies.

3. In the Number of CRF pages collected in the baseline visit field, enter the number of CRF pages that are to be collected during the screening and baseline visits.

   The value entered in this field should be the total number of CRF pages collected for enrolled subjects during their screening visits and during the baseline visit. Only enter the number of pages that are collected at the beginning of the study, not the number collected at the beginning of each treatment period.

   Note:

   The pages collected for candidates that do not pass screening is a value captured on the Subject tab.

4. The Baseline visit monitoring time required (in minutes) field displays the number of minutes required to monitor pages collected during the screening and baseline visit(s). The value displayed can be overridden.

5. In the Washout period duration field, enter the length of the washout period.

   The duration is specified in weeks for late stage trials and in days for Phase 1 trials.

   The washout period is the time between treatments in a cross-over trial in which subjects are not treated in an effort to reduce or avoid residual effects of the prior treatment from skewing the data or compromising the validity of the subsequent treatment(s).

   If data are collected during the washout period, you will need to configure that by clicking the link labeled, "Configure washout period.”

6. In the Treatment Duration field, enter the treatment length for each subject. The duration is specified in weeks for late state trials and in days for Phase 1 trials.

7. In the Visits per subject field, specify the number of visits for each subject during the treatment.

   A visit is a week (late stage) or day (Phase 1) in which one or more CRF pages are collected.

   For Phase 1 Healthy Volunteers trials in which subjects are confined and procedures are performed throughout the day on most or all days of treatment and/or washout, each day would be considered a visit.

8. In the Number of CRF pages per subject field, enter the number of Case Report Form (CRF) pages that will be collected for each subject during this treatment.

   This value should be inclusive of quality-of-life (QOL), pharmacoeconomic, and subject diary pages collected.

9. In the Number of QOL pages field, enter how many Quality of Life (QOL) pages will be collected during the treatment period.

   QOL pages are reviewed to see if they have been filled out by the study subjects, but usually require little or no monitoring

10. In the Number of Subject Diary Pages field, enter how many subject diary pages will be collected during the treatment period.

11. In the Number of Pharmacoeconomic pages field, enter the number of pharmacoeconomic pages that will be collected during the treatment period.

    These pages are reviewed to see if they have been filled out by the study subjects, but usually require little or no monitoring.

12. In the Cross-Over Design field, select a cross-over design to determine the specific sequences of treatments to which subjects will be randomized.

    ClearTrial currently supports either Latin Square or Balaam's Design. Balaam's Design is only applicable to a trial with two treatments.

13. Click Save.