As the demand for improving patient safety in clinical trials continues to rise, so will the use of technology as a way to better capture data and enhance clinical outcome assessments (COAs).
COAs, encompassing patient-reported outcomes (PROs), observer-reported outcomes, clinician-reported outcomes and performance-related outcomes, is a measure that describes or reflects how a patient feels, functions or survives. These measurements can include disease symptoms and the effect of a disease on a patient’s life. COA solutions can assist the diagnosis of diseases with complex or difficult etiology, in addition to facilitating the evaluation of therapies.
With the introduction of electronic medical records, clinical trials were presented with an ever-growing list of new data sources, including electronic clinical outcome assessments (eCOA), and bring your own device (BYOD). The adoption of eCOAs for clinical trial data collection is occurring at a rapid rate, replacing paper data collection methods. For example, eCOA solutions are harnessing the potential of digital technologies such as smartphones, tablets, wearables, interactive voice response systems and device apps to help clinicians, patients and their caregivers complete reporting.
Further, the adoption of cloud solutions, the creation of innovative data visualisation and reporting tools, and the need for integrated and automated workflows, will continue to grow the eCOA market. In fact, an analysis projected that the eCOA market will reach $2,630.26 million by 2027.1
The advantages of eCOA in clinical trial data collection
The use of eCOAs can improve data accuracy and reduce missing data, as well as refine site and user compliance. Also, the use of eCOAs creates patientricity by allowing participants to receive reminders to complete their assessments and provides flexibility in completing assessments wherever the patient is located, whether at home or the clinic.
What’s more, eCOAs allow for the implementation of branching the logic of questions, and reducing the length of questionnaires and patient burden. Skip patterns, which create a custom path that varies based on a respondent's answers, can be used to give patients a more personalised and user-friendly experience. Finally, eCOA can improve patients’ willingness to answer sensitive questions that they otherwise may not be comfortable answering.
Regulatory approval of eCOAs
Regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use support the use of eCOAs as electronic data can be easily tracked and time stamped, and are confidential and allow for data monitoring. Since 2012, many investigational products approved by the FDA and EMA include electronic PROs and daily patient diaries.
Considerations for incorporating eCOA
Although there are advantages to using eCOAs, there are also challenges in planning, such as detailing the technical requirements. When selecting an eCOA, the first step is ensuring that it will support the goals of the study and endpoints. For instance, sponsors should decide whether to use BYOD or provide devices to participants. Other complexities include considering country-specific variations in technology, proper training for study participants and sites, the length of study assessment and understanding the target population.
Once sponsors determine that implementing an eCOA is the right fit for a study, they should consider how it impacts other digital health modalities during the trial. For example, using only one device to collect data — such as a smartphone to complete case report forms and daily diary entries — can reduce participant burden and increase engagement.
Strategic partnership for proper implementation
The application of eCOAs to clinical trials requires an understanding of data capture modalities, proper training and the consideration of their impact on study outcomes. Involving a scientific expert well versed in eCOAs at the beginning of trial design can help guide this planning to ensure the scientific requirements are being properly considered. With a strategic partner, eCOAs can be successfully integrated into clinical trials, while maintaining patient safety and study integrity.
To learn more about implementing eCOAs, along with digital endpoints, read our white paper — Advancing digital endpoints: An end-to-end approach to managing wearable devices through clinical development.Read the whitepaper