In the exciting world of medical research, clinical trials represent a fundamental pillar for the development and approval of new treatments and therapies.
Throughout history, these studies have evolved and refined their methodology targeting at ensuring efficacy and safety in new drugs reaching the market.
In a growing digital world, the field of medical research has not been oblivious to technological innovations.
It is in this context, an innovative and transformative concept enters the scene, ePRO (Electronic Patient-Reported Outcomes) software, a tool designed to significantly streamline and improve data collection directly from patients who participate in clinical trials.
This new tool gained momentum during the pandemic caused by COVID-19, which led to avoiding travelling to medical centers as much as possible and promoting decentralized clinical trials, i.e., those in which most procedures do not take place in hospitals but in the participants’ homes.
This new tool gained momentum during the pandemic caused by COVID-19, which led to avoiding travelling to medical centers as much as possible and promoting decentralized clinical trials, i.e., those in which most procedures do not take place in hospitals but in the participants’ homes.
This new modality of data transmission has empowered patients and has eliminated the traditional limitations of paper questionnaires as well as evidenced the recent years increase in the involvement of participants.
Essentially, ePRO software applications make it possible for them to directly report data in clinical trials.
In this article, we will delve into the world of ePRO, as we will explain the characteristics of this software, its context, its relevance, and the devices with which this electronic solution can be made use of.
From patient experience to trial efficiency, and data-driven decision making, we will discover how ePRO systems are positioned as a crucial element in the future of medical research.
What is ePRO software?
These PRO are data on health status, symptoms and quality of life that are provided directly by participants, without interpretation by a healthcare professional.
Among the objectives of using ePRO software we encounter:
- Accurate data collection: Patients can record their experiences and symptoms directly into the system, minimizing errors and omissions.
- Facilitates patient-healthcare professional communication: ePRO software allows patients to share relevant information with physicians and healthcare teams. This strategy improves communication and decision-making.
- Results monitoring: By regularly recording results, the ePRO software enables detailed monitoring the patient’s health status evolution and the treatment effectiveness.
- Research and analysis: The data collected can be used to conduct research studies and analysis, contributing to medical knowledge and evidence-based decision making.
- Patient care improvement: By having a more complete view of the patient’s experience during the clinical trial, healthcare professionals can better tailor treatment plans to meet the individual needs of each participant.
Why are ePRO solutions so important today?
- Improving data accuracy and reliability: By allowing patients to directly report their symptoms, experiences, and quality of life, ePRO solutions avoid having to rely on the patient’s memory or the healthcare professional subjective interpretation. This increases collected data accuracy and reliability.
- Facilitating large-scale data collection: In clinical trials, research studies or long-term follow-up programs, manual data collection can be laborious and error prone. ePRO solutions enable more efficient data collection, especially when dealing with large groups of patients or extended periods of time.
- Increasing patient adherence and participation: Patients are often more willing to participate in the data collection process when they can do so electronically and at any time, ensuring their maximum convenience. This leads to greater adherence to treatment and greater participation in follow-up programs.
- Advancing research and evidence-based medicine: The systematic collection of patient-provided data through ePRO solutions contributes to the advancement of medical research and evidence-based medicine. This data can be used to identify patterns, evaluate the efficacy of treatments, and improve understanding of diseases and conditions.
What is a decentralized clinical trial?
ePRO systems are closely related to the concept of decentralized clinical trials (DCT).
A decentralized clinical trial, also known as a virtual clinical trial or remote clinical trial, is a type of medical research study in which patients are recruited, monitored, and treated remotely, using digital technologies and online platforms.
Unlike traditional clinical trials, where participants must physically go to specific medical centers, decentralized clinical trials allow patients to participate from home (minimizing their hospital visits).
In a decentralized clinical trial, various technologies are used to streamline the process, so many of the typical aspects of a trial are conducted remotely.
In this type of trial, recruitment, the signing of informed consent, data collection, monitoring, and even the provision of drugs, therapies or other treatments are carried out avoiding the patient having to travel to any medical center or hospital.
How does ePRO software optimize the conduct of a decentralized clinical trial?
ePRO software plays a key role in optimizing the conduct of a decentralized clinical trial by facilitating the remote data collection from participants and improving the overall efficiency of the study.
Some of the ways in which ePRO software contributes to the success of a decentralized clinical trial are described below.
Firstly, this software allows participants to complete questionnaires, report symptoms, and record relevant data from home.
This eliminates the need for physical visits to research centers and increases patient convenience and participation.
In addition, due to the possibility of electronically collecting data, investigators have access to said data in real time.
This allows continuous and up-to-date monitoring of trial progress, and the health status of participants.
Logically, by eliminating manual data collection, the risk of errors and omissions in the records is reduced.
The ePRO software generally includes validations and alerts to ensure the completeness and accuracy of the data entered.
On the other hand, this software offers an option of setting up reminders on the completion of questionnaires and specific follow-up dates.
This helps to maintain compliance with the trial protocol and ensure data collection at predetermined times.
Also, since investigators can access the collected data in real time, they are able to make immediate decisions and adjust the trial as needed.
Another positive aspect is that, through this tool, communication with participants is easier.
ePRO software has messaging and notification features to enable seamless communication between researchers and participants.
This helps to answer questions, provide important information, and maintain a close relationship with participants despite physical distance.
Regarding data security and privacy, these systems are often designed with high security standards to protect the privacy and confidentiality of participant data.
Finally, it is worth mentioning that by allowing participants to engage from any location with internet access, decentralized clinical trials with ePRO software can attract a more diverse and representative population.
What devices are ePRO applications used on?
ePRO applications can be used on a variety of electronic devices, allowing clinical trial patients to conveniently enter their health data.
Some of the most common devices on which ePRO applications can be run are listed below:
- Smartphones: These applications are typically available for mobile devices, such as iOS (iPhone) and Android smartphones. Smartphones are widely used and are easy-to-use platforms for patients to enter data, complete questionnaires, and record the progress of their health status.
- Tablets: Tablets, such as iPad and other Android devices, are also in use. These devices offer a larger screen than smartphones, which can be beneficial for longer questionnaires or more detail-seeking questionnaires.
- Desktops and laptops: In some cases, ePRO applications can also be used through web browsers. This provides greater convenience for some users who prefer to work on a larger screen or who do not have access to mobile devices.
- Monitoring devices: In addition to mobile devices and computers, some clinical trials may use specific devices to measure and record health status data. For example, blood glucose monitors, blood pressure devices, physical activity monitors, and others that are compatible with ePRO applications to collect real-time data.
It is important to note that the choice of device will depend on the target population and the nature of the clinical trial or data collection program.
Mobile devices are popular due to their ubiquity and ease of use, but it is also important to ensure that the ePRO application is compatible with different operating systems and devices to maximize user accessibility and engagement.
What types of data do patients report using ePRO systems?
Patients can transmit a wide variety of data through ePRO platforms.
This data typically relates to their health status, symptoms, quality of life, and overall experience during a treatment, clinical trial, or other healthcare program.
Some examples of the types of data that patients can report through ePRO systems are listed below.
Firstly, they can report the presence, intensity, and frequency of medical symptoms and signs related to their condition or treatment.
These include pain, fatigue, nausea, fever, and cough.
In addition, in these ePRO systems we have the option of including specific questionnaires to assess the quality of life of patients.
These questionnaires address aspects such as emotional, physical, social, and functional patient well-being.
Thirdly, participants have the possibility to report any side effects they experience because of the treatment, such as adverse reactions to medications or medical interventions.
In addition, this technological solution allows the inclusion of reminders and questionnaires to assess patient adherence to prescribed treatment, such as taking medications at the right time.
Demographic data and history are also included in these tools.
Patients can provide information about their age, gender, medical history, disease history, and other demographic data that is relevant for the study or treatment.
Sixthly, it is possible to integrate some ePRO systems into physical activity tracking applications to collect data on the patient’s daily activity, such as number of steps or exercise performed.
Other data, such as emotional and mental well-being, are also recorded, examples being anxiety, depression, or stress.
Finally, this application alerts patients of their medical appointments to ensure they follow the scheduled visit calendar.
It is important to keep in mind that the specific types of data transmitted through ePRO systems may vary depending on the purpose of the study.
The flexibility of these tools allows questionnaires and records to be tailored to the specific needs of each therapeutic area or treatment, thereby improving data collection and the patient experience.
Conclusion
In conclusion, ePRO tools play a crucial and highly beneficial role in the execution of decentralized clinical trials.
These technologies enable the remote collection of accurate and reliable data directly from participants, thereby simplifying logistics and increasing the efficiency of medical research studies.
Also, by eliminating the need for physical visits to research sites, ePRO tools increase patient convenience and participation, thus making recruitment easier.
In addition, ePRO tools provide investigators with real-time access to up-to-date data, enabling continuous monitoring of trial progress and participant health status.
This information supports sound decision making and more personalized medical care, thus improving the quality of study results.
By optimizing data collection, patient-investigator communication, and protocol adherence, ePRO tools contribute to greater compliance and success in decentralized clinical trials.
Undoubtedly, these technological solutions represent a significant advance in clinical research by enabling more active patient participation, and more accurate and efficient data collection in the virtual environment.
With the continued development and adoption of ePRO tools, decentralized clinical trials are likely to become an increasingly common practice in clinical research, so choosing a high-quality ePRO product is a good strategy for keeping up with advances in the research world.
In this regard, Sofpromed recommends the use of Klindat ePRO software, an ideal tool for clinical studies of any size and therapeutic area.
