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Features for manage clinical trial delays: Electronic Data Capture system OnlineCRF review

Published 30.07.2019

Today, more than 50% of clinical trials are conducted using EDC systems. They help to not only collect clinical data but are also a complete tool for managing trials. EDC systems have a functionality that allows access to the dynamics of the project as well as identifying delays and problem areas. More information about this can be found here.

Despite the opportunities offered by using EDC for project management, not all systems make this procedure simple and straightforward. You might have come across the fact that the manufacturer is confident in the simplicity and intuition of the EDC system, but when it comes down to the practical search for “bottlenecks,” there are difficulties that may arise.

When the EDC system’s developers take into account the specifics of the project and correctly optimized the interface, the analysis of the study dynamics and the identification of delays becomes easy and intuitive

As a rule, there are different types of tools in the EDC that help in working with project delays and monitoring. However, in most systems, each of these tools is dedicated to a specific task. For example, one of them helps to determine at which stage of the study the delay occurred. The other, in turn, provides information on a study site that does not fit the study deadlines. To get contacts for communication with this site, you should use another function. At the same time, all tools may not be connected to each other by a common interface, which complicates navigation even further and makes it unintuitive. To solve this problem, you need to find and open dozens of windows and tabs in search of information, which wastes a lot of time.

However, if the EDC system’s developers take into account this specificity and correctly optimize the interface, then the analysis of the project dynamics and identification of delays becomes easy and intuitive - up to the point that the whole process of finding a bottleneck is reduced to 3 clicks. To illustrate this architecture inside the EDC, we prepared an overview of the functions for working with delays in clinical trials using OnlineCRF system as an example.

Identification and analysis of the problem phase, which causes delays in the study

Step-1. Monitor project dynamics with real-time tools

The EDC OnlineCRF homepage contains a tool that shows a summary of the study dynamics - a dashboard. There you can see all the stages of the study and the number of patients associated with each stage. The graph helps to visually assess the number of subjects who are at the stages of inclusion, randomization, and so on, compared to the planned amount. One glance at the graph is enough to identify the problem phase of the clinical trial.

Dashboard of EDC system
GoalThe number of patients to be included in the research. There is the number of patients opposite each stage (created, screened etc.) — the number of subjects per the stage

For example, we see the difficulty at the stage of subject creation. As we can see, the doctors behind the inclusion schedule created 18 subjects instead of the 30 planned. It is important to understand what caused this issue.

Step-2. Find a site that creates delays at a certain stage of the trial

After we click on the problematic stage of the trial, the following window will open:

Dashboard: Finding a site that creates delays
Information on Dashboard about the number of subjects per site

This enables us to assess the activity of each of the sites that has already begun working on the project. Also, the actual and required number of patients that should be included by each site is indicated here. Evaluating the success of the site can be done by both analyzing the numbers and reviewing graphs. Graphs are especially convenient if there are many patients in the study and it is difficult to compare individual figures.

In this window, we can clearly identify the lagging site: 104. It hasn’t recruited patients at all.

Step-3. Find out about the problem site’s activity

Clicking on the problem site opens the following window. This window contains more detailed information, including data on-site activity. For example, if the site does not recruit patients, and there is no activity for more than a week, the responsible researcher should be contacted to ask about the problem.

Dashboard: site activity information
Information about site activity.
Age — site time in the EDC system

In our case, the lagging site was inactive (the doctor did not log in to the system) for only 15 days. This is a clear indicator that something went wrong. Therefore, it's time to contact the site and find out what the issue is.

Step-4. Learn detailed information about the site activity

There are situations when the site is active in the system but does not recruit new patients. In this case, it is worth remembering that the dashboard displays activity not only within this particular stage (in our case, the recruitment of patients) but the total user activity in the system. Therefore, the site could be active not in recruiting new patients, but, for example, in randomizing or filling a CRF.

Finding out exactly what the investigator did in the system requires the next tool.

You can go to the consolidated list of patients directly from the dashboard. It is automatically filtered so that only the patients from the problem site are shown.

Patience list in EDC system
Subjects list that shows information about site activities

Information on the status of each of the three patients that are included in the study is displayed here. The table shows which stages of the test the patient has passed, and where he/she is now.

The important information is the date and time of the status change. Thanks to this information, you can find out if the investigator has changed something relating to the patients’ statuses during their visit to the system.

For example, at the time of the analysis on the calendar 12/12/2018, the doctor last logged on to the system on 12/12/2018, but the last change was made on 03.12. This means that the investigator accessed the system but did not make any changes. In this case, you should contact the site and ask what the issue is. Perhaps the delay was caused by an internal problem on the site, and perhaps the site had difficulty working inside the EDC.

If the study is large-scale, the subject list may be lengthy, which means it is not convenient to view the date of each change. OnlineCRF provides a tool to search only those CRFs that have been changed during a given period. If the last time we checked the correctness of the changes was two days ago, then accordingly, we can choose the filter option “changes in the last 2 days”:

Patience list filters in EDC system
Filtres of last edited in subjects list

The patient list is a rather flexible tool with various functions. Therefore, there are still several possibilities for identifying problems and preventing delays in projects using it.

Solving the incompleteness of CRF filled in by the doctor

During the filling process, it may occur that the investigator cannot enter all the data at once. For example, at the screening stage, he or she fills in the data of a clinical examination but leaves the fields of the results of laboratory tests empty, since this data will only be available in three days. Due to the heavy workload, some investigators forget to return to the CRF after three days and enter the data. This may cause project delays, as a patient with an unfilled CRF will not get to the next stage of the study on time. However, these problems are easily identified using the EDC system.

Let's illustrate the example given above using just one tool - a patient list.

Patience list information
Information about data entering on a certain stage

In the list of patients, we can see that the subject was entered into the study on 12/03/18 (now it is 12/12/2018). In this case, the results of the lab tests were to come on 6 December 2018.

By accessing the patient list, we see the inscription: "No values ​​entered immediately,” which means that the CRF is not filled in, and the patient has not reached the randomization stage. Thus, it is not necessary to check the completeness of each CRF yourself - everything becomes clear at the stage of viewing the patient list.

Analysis of problems associated with dates of patients’ visits

One common cause of a delay in a clinical trial is the violation of inter-visit intervals. The subject must pass the second visit three days after the first one. But, in fact, he/she comes in five or even 10 days. Such situations, especially if they are systematic, may violate the timeframe of the study and lead to delays.

To find out whether patients make visits on time, you need to compare the actual and estimated dates of visits for each of the participants. This is quite a laborious process so, at OnlineCRF, we tried to make it as easy as possible by implementing the visit schedule special report. It records the planned date of the visit and the actual one automatically, compares them and calculates the number of delay days in the Deviation column.

EDC system report: Deviation of visits
Report with information about visit Deviation period

We can see the dates of actual and planned visits in the table. Also, in the column Deviation, the delay time is indicated. In our case, it becomes clear that all patients on visit 2 came with a delay. As this happens systematically, it is possible that investigation sites have a problem that does not allow them to adhere to the deadlines. You can try to fix the problem by contacting the doctors, so the visit schedule meets the protocol requirements.

Checklist: Actions to be undertaken to prevent unexpected delays in a clinical trial

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