How to avoid delays in clinical research using an EDC system? Useful features to track project and to identify bottlenecks

Studies show that more than 85% of all clinical trials are delayed a month or more due to disorganized data capture and retrieval methods. Missed deadlines due to time lost in clinical data collection result in additional expenses and the loss of funding. In many cases, useful drugs and treatments fail to come to market as a result of these preventable problems.

Professionals in clinical research understand the importance of making the most of available resources and saving time. To this end, we have advanced tools like electronic data capture (EDC) systems.

Delays can occur at any stage of a study, for example:

• Initial Stages. Information bottlenecks may appear during a subject’s screening or during a randomization phase.


• The Middle Phases. Delays during the middle portion of a study may be related to inefficient laboratory procedures, a lack of resources, or problems with instrumental diagnostics.


• The Final Stages. Delays in the final stage of a study are associated with excessive questionable data sets requiring extensive review.

An electronic data capture (EDC) system can effectively identify specific problems behind clinical data collection delays. These systems allow research teams to analyze the progress of a project, and to understand where a given bottleneck occurred. Once a data bottleneck is identified, it is a straightforward task to analyze and eliminate the problem.

An EDC makes it easy to identify specific problems.

Lets see a few examples

Example 1. In some cases, subjects in one trial site may be actively screened, but are not randomized for some reason. In this case, the clinical trial software will alert the clinical research coordinator or remote monitor at an early stage - before the problem becomes unmanageable. At that point, the clinical research coordinator or remote monitor can contact a program director and pro-actively develop a solution.

Example 2. Two clinical research assistants working different shifts organize rows and columns in a spreadsheet according to a different procedure. Maybe one is logging treatments according to a randomizing algorithm, and the other is not - and there is no direct communication about this problem between the two assistants.

Example 3. Problems in randomization can occur when interactions with subjects are not properly recorded or when treatments are given in a procedural fashion rather than algorithmically. When the interface of the data collection system is designed properly, information indicating these problems is automatically reported by the system. Intuitive, high quality EDC presents issues like these clearly to the end user, making revisions simpler and more intuitive.

Investigators rarely report difficulties like these. It is critical that such events be detected promptly via remote monitoring using EDC. The EDC will identify problems and alert the team at an early stage before the data is hopelessly corrupted.

EDC systems help, not only in the collection of clinical data, but also serve as an important resource of information about project dynamics and clinician activity and in some cases can be used as a clinical trial management systems (CTMS software).

EDC delay management tools

Delays in a clinical trial can have many root causes and occur at various stages of data collection, however, there are several ways to keep track of these delays in EDC systems.

Reports

Most EDC systems available on the market have this feature built in. The reporting module allows the generation of pre-configured reports which show different metrics or activities. These reports can display the overall progress of subject enrollment (at a country level or study site level). Other types of predefined reports can monitor query resolution, source data verification (SDV), data cleaning may also be available depending on the system utilized. Once the report is generated, it projects the current picture, but it must be remembered that new subjects continually enroll in the study, randomize and exclude. These changes modify multiple parameters, and the previous report becomes outdated.

Real-time project tracking

This type of tool is convenient for tracking the progress of the study, but it is not available in most existing clinical study software. This module is technically challenging, so the presence of the real-time project tracking module is a sign of sophisticated software. This module looks like a dashboard at the starting page and serves as a tool for observing the vital project metrics in a convenient form. This dashboard provides a current picture of a project and saves a considerable amount of time and efforts for the project manager or managing team.

As an example of the real-time tracking tool, we can mention the widget for the monitoring of site study activity. We can observe the study site activity calculating the number of subjects which are treated by the selected study site. Most of the available EDCs display the long table, in which you can see the status of each patient. This can be convenient if you are focused on patient data.

However, when you try to see the overall picture at a site level, this table becomes inefficient: you cannot see the total number of screened, randomized or withdrawn subjects.

What is the solution? The data collection system can automatically calculate the number of screened or randomized subjects and show the number near the study site code. This number is updated if a new patient becomes screened or randomized. So, you can see a dynamic picture of study site activity and rapidly identify active study sites and inactive study sites. If a given study site promised a high level of patient recruitment, and the monitor sees zero patients, this will be evident from the first look at the dashboard. Remote monitor identifies this issue and knows exactly who is responsible. They can ask the specific question: “What is the reason for this low enrollment, how can I help you?”.

This is an example of how a good dashboard can help to track a project, identify issues and proactively resolve possible bottlenecks. There are many examples that show the usefulness of real-time project tracking, but we can’t describe them here. The best way to understand the advantage of real-time progress tracking dashboards, widgets or metrics is to use electronic data collection systems which have these tools onboard.

The best way to present tracking data for the end-user is a graph. If the type of graph is chosen correctly, it makes data perception an easy task. In the picture below you can see a widget which shows the overall study statistics, which is built around the statuses of subjects. A quick view gives an immediate understanding of patient enrollment, randomization, CRF completion, and e-signing.

The automatic notifications set up

Some EDC systems allow the setting up of notifications, indicating that one of the stages of a project is lasting longer than it is supposed to. For example, information entered into the system indicates that ten subjects should be randomized by December 25th. If deadlines are not followed, the system sends a notification. After that, the manager clarifies the reason for the delay and eliminates it.

EDC tool helps to avoid delays with the help of convenient tools such as reports, dashboards, notifications, and real-time project status tracking.

Therefore, the use of electronic systems for managing clinical research reduces the risks of delays and deadline violations. That's why a steady configuration and customization procedure will speed up further stages of data collection.

OnlineCRF is a convenient system to manage a project

OnlineCRF is a popular EDC system as a data capture solution in clinical research. The OnlineCRF team has developed convenient tools that allow the monitoring of project dynamics in real-time mode. The user-friendly interface will help to identify bottlenecks quickly and eliminate them effectively.