Saturday, 23 November 2019 04:51

How mobile apps improve the ability to reach essential patient data in clinical trials

Online CRF Online CRF

The production of new drugs is a complex and resource-consuming process. Before a drug hits the market, it must be tested for safety and effectiveness. Firstly, the drugs are tested in the laboratory, and then they move onto the clinical trial stage.

Clinical data is collected predominantly in two ways. The first is with clinical examination, instrumental, and laboratory studies. All of these are carried out under the guidance of a doctor in a clinic. This information is also collected in the Case Report Form (CRF). The second way is data collection by the patient. This means that the patient can independently register their body temperature, and note symptoms. The patient enters the data into a special questionnaire and a diary.

Initially, paper CRFs and diaries were used to collect data within a clinical study. However they had numerous and significant shortcomings, including the inconvenience of filling. Therefore, in modern research practice, a paperless approach is utilized. Various electronic tools are used to collect data. These tools can be in the form of computer programs, and also in the form of applications on smartphones and tablets. The second approach is particularly useful for patients. In this text, we will focus on mobile apps that are used by participants in clinical trials.

Apps for patients

During a clinical trial, patient interest and involvement are critical. After all, a participant in a project can collect a large amount of clinically significant and valuable data on their own. And the more efficiently he or she does it, the more qualitative data will be collected for the analysis of the drug. Therefore, pharmaceutical and IT companies put a lot of effort into developing convenient tools for subjects. Such platforms are called Electronic Patient-Reported Outcome (ePRO), and these are primarily special applications for mobile and tablets.

Using the application, patients can fill out health questionnaires or enter data without leaving home and using only one application.

How mobile apps improve the ability to reach critical data

Using mobile apps in a clinical trial has many advantages and can generally affect the success of drug research projects.

A convenient way to transfer data for the patient

Using a mobile application does not require special skills. Typically, ePRO applications are installed and ready to go in a few clicks. Immediately after installation and authorization, the patient can begin entering data. ePRO creates simple questionnaires with an intuitive interface to fill out.

The applications also have a reminder system (for example, signals that you need to register body temperature or take the studied drug). A reminder system for the next visit to the doctor can be set up too.

These and other functions make volunteer participation in a clinical trial as comfortable and simple as possible. This increases people’s involvement and interest in the project.

Adverse event (AE) rapid response system 

ePRO systems have functionality for quick reporting of adverse reactions or events. As soon as the patient feels unwell, he or she can and must inform the attending physician. Through the application, this can be done faster and more conveniently, as telephone communication with the doctor may not always be possible.

A doctor-researcher or other responsible person will immediately respond to such a message. If an AE causes severe discomfort or poses a threat, he or she will be able to quickly solve the problem and provide assistance to the patient.

Data received through ePRO automatically enters the database and can be quickly analyzed. This will help researchers pay special attention to the health status of other participants in the study and, if necessary, adjust the medication plan or suspend the test entirely.

Convenience of information processing and access to it 

The benefits of using ePRO apply not only to patient experience but also to the work of the entire clinical research project team.

The ePRO application is usually tightly integrated with the data acquisition system (EDC system). An example of an EDC system is OnlineCRF. The application is synchronized with the central database in EDC, which helps to avoid manual migration, and optimizes the efforts of the project team to process data.

Reduce the project duration

This paragraph derives in part from the previous ones. Due to the fact that the data collection process is optimized, and data is collected efficiently, the time spent on the process of updating and clarifying information is reduced. This decreases the probability of delays in research, and, in some cases, the project can even be completed earlier than planned.

Mobile applications in clinical research are an important work tool. One of the most commonly used tools is ePRO, which is intended for entering patient data. Thanks to a convenient and simple interface, a volunteer can take out all the critical information in a few minutes a day. This improves the quality of the entire study and helps to obtain a full range of patient health information.

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