What Is ePRO Software in Clinical Trials?
If you need ePRO software, you can contact us at info@klindat.com
In recent years, patients have become more involved in the design and execution of clinical trials.
Increasingly, the voice, concerns, and participation of patients in clinical trials has been on the rise, resulting in more patient-centered clinical research.
A good example of this is cancer clinical trials, in which the use of quality-of-life questionnaires has been standardized —patient well-being has gained more prominence— as important information that should always be collected.
At the same time, patients’ opinions are taken more into account in the design of clinical trials, involving them in the drafting of informed consents and giving them a say in the design of the study as well as the schedules of visits to the hospital.
With regard to clinical trial data, patients have also become more and more involved through ePROs —electronic Patient-Reported Outcomes—, which essentially entails the reporting of data and results by patients themselves through electronic means.
In other words, patients themselves now enter data directly into the study systems (for example, data related to how they feel about the clinical trial treatments).
This direct transmission of clinical data by patients —remotely through the use of computers and tablets— was of great importance and was exceptionally promoted during the COVID-19 pandemic, since at the height of the virus there were many restrictions that limited patients’ access to hospitals in person.
Therefore, during the time of the pandemic, the use of software tools that allowed patients to provide information remotely —without the need to go to the hospital— was maximized.
Without a doubt, ePRO systems are here to stay and are now regarded as fundamental tools in clinical trials.
But what exactly are ePRO systems and what are their features?
Below we will describe the advantages of these software tools and what aspects should be considered when acquiring these applications to conduct a clinical trial.
What Is an ePRO Software?
An ePRO (electronic Patient-Reported Outcomes) software is a web-based application designed to allow patients themselves to enter data into a clinical trial, using a computer or tablet.
In contrast to a traditional Case Report Form (CRF) —in which data are entered by hospital staff— in an ePRO system, patients themselves enter clinical information directly into the study database.
Why Are ePRO Applications Necessary?
ePRO software tools have become very relevant in recent years because the direct involvement of patients in data generation has increased.
Many clinical trials are designed with the aim of collecting and analyzing data related to the quality of life, feelings, and perceptions that patients have while participating in a clinical study.
Does a drug reduce the pain experienced by the patient? Does a therapy improve the quality of daily life? Has a new treatment succeeded in reducing the use of other painkillers?
All these questions are necessary to determine whether a new experimental treatment can improve the symptoms of patients participating in a clinical trial.
The most efficient way to obtain this information is for patients themselves to directly report data on their health and well-being, by using technological tools adapted to their capabilities and personal situation.
How Do ePRO Tools Improve Logistics Efficiency in a Clinical Trial?
Another of the main reasons why ePRO systems have become key tools is the optimization of logistics efficiency.
ePRO platforms reduce the need for patient visits to the hospital, since information can now be communicated by the patient from home, without the need to travel to the clinical center.
At the same time, as the patient is the direct user of the software into which the study data are entered, the need for someone else to transcribe the information from a paper form into an electronic database is eliminated.
In this way, ePRO systems reduce travel costs for patients and allow for savings in personnel costs when entering information into the clinical trial database.
All this translates into more convenience for patients, less effort for medical professionals, and more savings for clinical trial sponsors.
What Are Examples of Questionnaires that Patients Fill Out in an ePRO System?
There are different types of questionnaires that patients fill out in clinical trials, depending on the therapeutic area and the main objectives of each study.
Specifically, ePROs can be in the form of a diary, a scale, or a questionnaire, and must provide quantitative data.
Questionnaires often contain numerical scales, allowing researchers to identify any changes in the patient before, during, or after a treatment.
The questionnaires used in ePRO systems are designed to standardize responses —with predefined values— thus trying to ensure that they are not open to interpretations that could lead to bias in the assessment.
Some examples of questionnaires used in oncology are presented below:
- EORTC Core Quality of Life questionnaire (EORTC QLQ-C30). It measures the quality of life of cancer patients.
- The Brief Pain Inventory (BPI). It measures the pain experienced by patients.
- The Functional Assessment of Cancer Therapy – General (FACT-G). It measures the physical, emotional, and functional well-being of cancer patients.
What Devices Do Patients Need to Use ePRO Software?
ePRO software systems require the use of hardware devices.
However, the physical devices needed to use ePRO software are commonly used (e.g., desktop computers, laptops, or tablets).
Patients usually access ePRO systems with their own computers —via a website with a username and password— or by using a tablet.
It is also very common for clinical trial sponsors to provide patients with electronic tablets to facilitate access to the ePRO application, as in some cases patients do not have these devices.
What Design Features Should ePRO Applications Have?
The designers of ePRO software applications must consider the particularities of the users, who in this case are patients that are not always familiar with new technologies.
Hence, above all, an ePRO tool must be very simple and easy to use, in order to prevent the patient from having problems when using it, thus avoiding frustrations that may lead to their abandonment of the trial.
The importance of this simplicity of design cannot be sufficiently emphasized. If we think of patients that are unfamiliar with new technologies —and sometimes elderly patients— simplicity, clarity, and ease of use are paramount requirements for a successful ePRO application.
In fact, an ePRO tool not only has to be intuitive and easy to use, but it must also include simple help messages and guides to orient the patient, so that he or she has no doubts when accessing the platform and can navigate and fill in the data with the utmost ease.
A complex, information-heavy, and unfriendly ePRO platform can lead to study failure, as patients will find it difficult to enter data, and frustration will begin to set in for all parties involved in the management of the clinical trial.
Who Provides ePRO Software Applications?
There are several manufacturers of ePRO applications on the market today, and clinical trial sponsors have a wide range of options to choose from.
Manufacturers of ePRO systems are companies specifically dedicated to the development of clinical trial software.
As is the case in all sectors, there are manufacturers of ePRO products of different sizes that offer more or less advanced solutions at different prices.
In this sense, clinical trial sponsors need to consider the budget available to purchase the ePRO system as well as the vendor profile that best suits the characteristics of their project.
As an example, a global pharmaceutical company might consider a multinational ePRO manufacturer with highly advanced systems, in case they need to run a very large clinical trial with high demands.
On the other hand, a non-profit, academic research group with a modest budget —with a study of just a few hospitals in mind— might be more interested in contracting with a smaller, lower-priced ePRO software provider.
How Much Does an ePRO Software Application Cost?
As mentioned above, various types of manufacturers can be found on the market offering their ePRO software solutions at different rates.
At this point, it is useful to mention the common billing model that companies offering software tools for clinical trials often use.
ePRO software tools typically involve two main costs: (1) the initial implementation of the system and (2) a monthly fee for the use and hosting of the tool.
Bearing this in mind, the price of an ePRO solution will depend on the number and size of forms or questionnaires to be implemented, the number of patients who will use the application, and the duration of the clinical study.
As a very general guideline, an ePRO software application can have a cost of around 4,000 $ – 12,000 $ for initial implementation, and then between 400 $ – 4,000 $ per month for licensing and hosting.
As can be seen, the range of monthly costs is quite wide, and this is due to the fact that there are ePRO applications with different levels of sophistication —with more or less powerful functions— that offer different features depending on the size and needs of each clinical trial.
Conclusion
The use of ePRO software applications has increased dramatically in recent years due to the growing participation and involvement of patients in clinical trials.
ePRO systems facilitate the direct transmission of data from patients, saving effort and money for all parties involved in the study.
One of the keys to the success of an ePRO tool is its simplicity of design and ease of use, as this will allow for a high degree of correct data entry.
There are multiple ePRO software providers on the market and each sponsor will need to evaluate which company to work with and which product is most suitable given the size of the clinical trial and the budget available.
If you need ePRO software, you can contact us at info@klindat.com
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