Use Case


The Study tab, as part of the Executive Summary dashboard, presents a thorough understanding of study progress. For a specific study, the dashboard renders data from various clinical perspectives of performance assessment. These study- performance governing factors, such as milestones achieved, enrollment and site activation behavior and so on are discussed below and a compilation of such helps the project manager drive conclusive action.


The Study tab


The following sections and content are all part of the Study tab of the Executive Summary dashboard.


Summary Cards


Select a study name from the Study dropdown selection box and observe the following summary cards render data with respect to the study selected.


  • Study Title
  • Therapeutic Area
  • Primary Endpoint - If this data is large, then a "More" sign will appear next to it. The user can hover over the ellipsis sign to see the complete data for this field.
  • Indication
  • Study Drug
  • CRO

Study specifications for the selected study are enlisted on these summary cards below. These are:


  • Countries - This tile shows the Planned and Actual count of countries for the selected study. Click the count to see the list of countries under Planned and under Actual. If Planned count is missing, then a horizontal ellipsis will be seen in place of count.
  • Sites - This tile shows the Planned and Actual count of sites for the selected study. Click the Actual count to see the number of active sites in a specific region.
  • Subjects - This tile shows the Planned and Actual count of subjects for the selected study. 
  • Recruitment Duration - Recruitment duration refers to the number of days from the first site activated till the present day if the study has not been completed or till the Last Subject First Visit milestone has been reached.
  • Global Recruitment Rate - Global Recruitment Rate refers to the actual recruitment rate evaluated across all countries of the selected study. Click here to see the derivations.



Key KPIs


Some of the relevant study governing factors, such as KPIs, are measured or derived for the selected study. A quick observation of the same helps to evaluate study performance till date. These KPIs are discussed below:


  • Screening - Shows the count and percentage of screen failures.
  • Withdrawn - Shows the count and percentage of subjects withdrawn.
  • %Enrolled - Shows the count of subjects enrolled till date. It also shows the count of subjects planned for enrollment upto the current month as well as the total planned enrollment.
  • %Site Activation -  Shows the count of sites activated till date. It also shows the count of sites planned upto the current month as well as the total sites planned.  



Enrollment by Arm/Cohort


The Enrollment by Arm/Cohort widget shows the planned and actual count of subjects enrolled against each arm/cohort of the selected study.

Click Export to CSV to download the list of subjects enrolled as a CSV file.



Site Activation and Enrollment Over Time

In any study, the rate of site activation and enrollment has a direct impact on the study timeline. This widget provides insights into enrollment and site activation with actual and planned numbers, month after month and also derives a cumulative total over a period of time to give a fair estimation on clinical trial progress.


By Month

The Site Activation and Enrollment Over Time widget helps you monitor actual site activation and actual enrollment against planned numbers, for a selected study, for every month or for a chosen time frame. 

Site Activation and Enrollment Over Time widget is presented through a bar chart, data points of which are determined for every month as represented on the time reference X-axis. These bars display planned versus actual site activation and enrollment numbers over time. The various representations are listed below:

  • Planned Site Activation (Monthly)
  • Actual Site Activation (Monthly)
  • Planned Enrollment Count (Monthly)
  • Actual Enrollment Count (Monthly)
  • Planned Site Activation Milestone (*)
  • Target Enrollment
  • Target Site Activation

The metric Planned Site Activation milestone (*) marks the graph at specific ‘milestone’ points as a bar with an asterisk on top, that indicate targets that can be aimed for, such as, 1st Planned Site Activation, 50% Planned Site Activation.

You can select a time frame/period through the horizontal selection bar or choose a pre-defined time period to get a more focused result. Select the time stamps, such as, 1m, 3m, 6m, 1y to see the data in the last month, last 3 months, last 6 months, or last 1 year respectively, based on the time period visible in the widget. Select All to see data over the entire timeline.

Note: 
  • Click on a category in the data legend to eliminate or to add its visibility in the bar chart.
  • Enrollment and enrollment rate calculation will be maximized when the LPLD (Last Patient Last Dose) milestone is achieved. If LPLD is not available, then the LPLV (Last Patient Last Visit) milestone date is considered.


By Cumulative


The Site Activation and Enrollment Over Time widget helps you monitor actual site activation, planned site activation milestones, and actual enrollment achieved over a period of time against the projected or estimated enrollment and site activation counts, for a selected study.

The widget is presented through two distinct line charts and a bar chart, data points of which are determined for every month as represented on the time reference X-axis. These line charts and the bars display planned versus actual site activation and enrollment numbers over time. The various representations are listed below: 

  • Cumulative Actual Enrollment - Renders data as per the selection made in the Cohort dashboard filter.
  • Projected Enrollment Cumulative (Most likely forecast)
  • Cumulative Site Activated
  • Planned Site Activation Milestone (*)
  • Target Enrollment
  • Target Site Activation


Note: Click on a category in the data legend to eliminate or to add its visibility in the chart.


The metrics Cumulative Actual Enrollment and Cumulative Site Activated give the total number of enrolled(actual) and the total number of activated sites (actual), respectively, over a period of several months up until the month selected in the widget.


The metric Projected Enrollment Cumulative (most likely forecast) presents a specific point in the graph that would indicate the most likely estimation of enrollment in the near future. The projected enrollment or enrollment forecast assessment, defined as Realistic (most likely forecast) is based on the Monte Carlo algorithm which calculates the rate of enrollment if all the following prerequisite conditions are met.


The metric Target Enrollment presents a count of enrollment that is desired to be attained for the selected study. The projected enrollment or enrollment forecast assessment, defined as Realistic (most likely forecast) is based on the Monte Carlo algorithm which calculates the rate of enrollment if all the following prerequisite conditions are met.


  1. Actual Enrollment should be less than the Planned (Targeted) enrollment. 

    Note: If the planned enrollment count is achieved, then the enrollment forecast will be marked on the date on which the target enrollment was achieved.
  2. Participating sites (where count of sites > zero) should be actively enrolling patients for the last six months. 

  3. A minimum of 2 sites should have enrollment count. If the count of sites that are enrolling is less than 2, then the forecast cannot be calculated.

  4. Sufficient number of sites may have an enrollment count but if a reliable enrollment rate cannot be achieved then the enrollment forecast is not calculated, despite the enrollment data gathered. A minimum of two sites must have their respective enrollment rates above zero.

  5. A collective planned enrollment of 25% should be achieved when taking into account all the participating sites.

 Note: The enrollment forecast will be visible, on the graph, only if all of the above conditions are satisfied.

The metric Target Site Activation presents a site activation count that is desired to be attained for the selected study. 


Site Activation & Enrollment by Country


The Site Activation and Enrollment by Country widget displays the planned and actual count of site activation and enrollment across every participating country of the selected study.



Click Export to CSV to download the resultant/filtered data, fetched by this widget, in a CSV format.


Freeze/Un-Freeze & Hide/Un-Hide Columns

Click the Settings icon that appears at the top right corner to freeze/un-freeze, hide/un-hide one or more columns in the Site Activation & Enrollment by Country tabular listing and the Enrollment By Arm/Cohort tabular listing. Columns that are marked for 'freeze' appear at the leftmost end of the widget table and remain visible as the user scrolls towards the right. The columns in Site Activation & Enrollment by Country listing can also be sorted individually. The columns in Enrollment By Arm/Cohort can be sorted individually. A user with 'Admin' access to the application can click Save Configs to save the UI changes performed on the widget table/listing. The application shall retain the following UI configurations settings for subsequent application logins, even after the user logs out of the application, until these UI configurations are revisited again and modified. These are: i) freeze/un-freeze columns ii) hide/un-hide columns iii) sort column values 
Click Reset Configs to remove or reset any of the UI configuration changes applied through the Settings icon. 
Note: Only an application user with 'Admin' access can save/reset the UI configuration changes mentioned above. An application user with 'Basic' access to the application can apply and see the UI configurations till the session is active or till he/she logs out.


Study Milestones


The Study Milestones widget presents a good understanding of all study-specific milestones that have been achieved over a period of time. The delay occurred in achieving each one of them is recorded for good understanding.



Query by Study


The Query by Study widget draws focus on query aging with ease. All open queries are grouped into two categories, that is, Answered and Unanswered and the count in each category is further bracketed into different time frames as the query ages. The Query by Study widget also lists the count of queries in each of the following categories:

  • Opened
  • Answered
  • Cancelled
  • Closed




Tips & Features


  • The count seen in Key KPIs is determined by the most recent USDM refresh.
  • The Target Enrollment count and Target Site Activation count are directly fetched from the USDM table.



Included Filters


The application of the following dashboard level filter renders data across all summary cards and widgets as per the specified filter criteria. By default, the dashboard renders data for the study name that appears first alphanumerically. 


  • Study - This single-select filter is used to select the study of interest for analysis.


Click the funnel-shaped icon that appears on the top right corner of the dashboard to show or hide the dashboard filter section.



Related Analytics

Interpretation


The Study component of the Executive Summary dashboard, captured in the Study tab, facilitates the user to have access to detailed insights about a specific study of interest. The visibility of numbers in various governing aspects of a study's performance help in driving conclusive action.


The Key KPIs highlight the number and percentage of subjects that fall into each of the KPI buckets giving away a good understanding of feasible study progress.


The Enrollment by Arm/Cohort gives the count of subjects enrolled in each of the arms of the specific study of interest. These numbers drive business choices on having more subjects or understanding the feasibility of study assessment.


The Site Activation and Enrollment Over Time widget gives crucial insights into monthly assessment of study through visibility in enrollment count and site activation count. The Target Enrollment and Target Site Activation numbers helps in assessing the alignment of study performance that will enable successful evaluation of the clinical trial.


The Site Activation & Enrollment by Country marks the study progress in each country through visibility in enrollment and site activation numbers.


The Study Milestones widget tracks the milestones achieved through the movement of study in time. The delay occurred in reaching study milestones is recorded for performance analysis.


The Query by Study widget takes notes of all queries received and positions them in the right query buckets. Query aging is recorded on all open and answered queries and this works as an effective tool to drive conclusive action.


Export Options


Click Export Analytics to PDF that appears at the end of the dashboard to export or download data from all components of the dashboard in PDF format. If data on the dashboard is rendered as per any filter criteria specified by the user, then the same is captured in the PDF export.