In today’s fast-evolving clinical research landscape, the shift from paper-based Patient-Reported Outcomes (PROs) to electronic PROs (ePROs) is fast gaining traction. ePRO-based clinical trials exhibit a compliance rate of around 90% to 97% – much higher than that of paper-based trials, which is at only ~30%. The adoption of ePROs is revolutionising clinical trials, helping streamline the data capture and rating process – from recording symptoms to delivering the outcome. Let’s delve into how implementing ePROs in clinical trials really makes sense.
Paper-based PRO Barriers
Providing health professionals with knowledge of the patient’s function and their quality of life (QoL) is vital to delivering patient‐centric quality healthcare. However, the paper-based PRO process makes the process of capturing patient symptoms, tests, etc, stressing the importance of switching the ePROs.
Some barriers to paper-based PROs that make trial outcomes erroneous and arduous include:
Time-consuming for Patients
One of the leading challenges patients face in a traditional paper-based trial is to fill up the patient reported outcome measures (PROMs). PROMs are questions that participants answer to assess their own health status, including symptoms and mental and physical conditions. It’s essential for health professionals (HPs) to effectively measure PROs and get insight into a participant’s health. Patients with serious illnesses often struggle to complete Patient-Reported Outcome Measures (PROMs) due to the demanding nature of their treatments and frequent medical appointments. This greatly impacts the results of the trial. Long paper questionnaires can also cause subjects to miss some questions, leading to missing data that is important for analysis. Lost data can also result from a subject’s inability to complete PROMs, forgetting symptoms, and more.
Time-Consuming and Erroneous Process for HPs
HPs may sometimes find it time-consuming to check, interpret, and validate the self-reported questionnaires in traditional paper-based PROs. In paper-based trials, the coordinator needs to manually enter data from participants into a Case Report Form (CRF). That can result in transcription errors. Such human errors elongate the trial process, leading to trial setbacks, site closeout delays, and more.
Adds Up the Cost
A traditional trial is more likely to include falsified, incomplete, conflicting, and misleading diary entries. Such inaccuracies cause the study teams to review the PROMs, enter data, and keep asking subjects for follow-up data. Sometimes, identifying errors and retrieving accurate or missing data can be delayed, which makes the process take more time. Even though the initial cost of a PRO-based trial may seem low, the cost it needs clinical research organisations (CROs) to spend on labour steadily spirals upward.
ePRO—A Practical Solution to Barriers in Paper-based PRO
Enabling CROs to adopt a patient-first approach while conducting clinical trials helps address the issues that emerge in traditional paper-based PROs. The benefits of ePRO include:
Capturing patient-reported outcomes electronically improves compliance in clinical trials. From the comfort of their homes, participants can complete questionnaires using their computers or smartphones, significantly reducing patient burden. This approach improves patient experience and helps them follow trial protocols, which improves data quality.
In addition, the built-in alarms in some ePROs help patients stay on track and submit their health status on time in their diaries. It drives greater data completion and accuracy while also reducing the risk of data loss. That mitigates one of the leading challenges trial teams face with paper-based data entry processes.
Automated and Streamlined Workflow
By automating data management functions—data review, collection, verification, and data archive—ePROs significantly reduce the administrative burden on site staff and accelerate study timelines. The capability of ePRO to streamline study workflow minimises human errors, potentially expediting the process of delivering life-changing treatments to the market.
It’s evident that the cost of purchasing, implementing, and training staff and patients on the efficient use of ePROs can be high. However, standardised ePRO components can be recycled, meaning the questionnaire designed for a study can be stored in built-in electronic libraries. So, trial teams can retrieve the questionnaires and reuse them many times. It not only makes the process highly standardised, but also enables CROs to skip investment in development.
Again, when a study is completed, the ePRO data is readily available within the study database, speeding up the process of closing out the trial. Involving far less labor than traditional paper-based PROs, ePROs help CROs slash a significant amount of the cost.
Reduces the Workload of Trial Teams
Trial teams can review data entered by the participants in real time. As a result, the possibility of lost, non-compliant, and missing data is significantly minimised. With high compliance rates and ensuring data accuracy, trail teams implementing ePRO can often collect sufficient data from fewer subjects and investigative sites.
However, the subjectivity characterising ePRO is difficult to overcome, compromising trial endpoints and data accuracy. Trail sponsors are urged to leverage ePROs that leverage AI augmentation provided by expert VROs such as ObvioHealth to overcome the industry-wide problem associated with the data capture and rating process.
Sohela is an electrical engineer and a self-professed writer with a keen interest in all things tech. When she’s not writing killer content pieces, you’ll find her enjoying tempting foods in her favourite restaurants.