Embracing an eCOA strategy: Making the switch from paper diaries

The changing face of healthcare continues to drive the reevaluation of care and clinical research approaches. Life sciences organizations have had to quickly adapt and adopt technology to effectively engage clinical study participants amidst more decentralized clinical trials (DCTs). Now, thanks to being faster, on-demand, and more customizable, DCTs are here to stay. As sponsors begin to acknowledge how useful technology has become in the shift to DCTs, adopting an electronic clinical outcome assessment (eCOA) strategy is a vital step to ensure that each clinical trial captures the same level of detail as traditional paper diaries while also improving operational efficiency, data integrity, regulatory compliance, and the experience of participants.

Understanding the challenges of paper-based assessments

The traditional approach to paper-based, handwritten patient assessments faces challenges related to timelines, patient experience, data quality, security, and much more. As the industry continues to move towards a more comprehensive picture of treatment benefits, patient-reported outcomes (PROs) have become the new benchmark for regulators and payers to measure the quality of a drug or therapy. This shift has made COAs a necessary tool in the clinical research landscape to support eventual regulatory review and approval. For this reason, organizations must ensure they are able to consistently collect complete COAs, especially in the new DCT environment. Some of the significant challenges include:

• Hindered patient experience: Gathering patient perspectives is critical in understanding PROs, which leaves the patient with the tedious task of daily summaries and quantitative or qualitative measures for specific times of the day. With traditional trials using paper-based assessments, it’s the patients’ responsibility to remember to complete their paper diaries in accordance with protocol-specific reporting windows. Without the availability of automated reminders and date/time stamps in paper diaries, the door is open for suspect data, missing data, and non-compliance. This historical approach to paper COAs leaves patients with an exorbitant burden and can greatly hinder data collection and analysis for the sponsor.
• Excess time spent: Just like patients spending excessive time filling out paper assessments, sponsor data management teams need to invest additional time transcribing paper diaries into electronic data capture systems while also applying data cleaning practices. This includes investigation of anomalous data and may even include double-entry verification.
• Completeness of the data: Traditional paper-based data collection makes real-time insights impossible to gather and understand in a timely manner. Sponsors lack visibility into trial progress, such as recruitment, safety data points, and data collection associated with key study endpoints. Without transparency into the data on an ongoing and real-time basis, it becomes challenging to monitor the study and perform interim analyses, which are needed to inform adaptive trial designs.

Making the switch from paper diaries to eCOA

While many factors are prompting the industry-wide migration to electronic diaries, patient centricity is at the core of the movement. The increasing use of DCT models has forced sponsors to reconsider how patients participate in clinical trial data collection, time spent at on-site appointments, and how technology can enhance the patients’ overall experience. Replacing paper with eCOA strategies, such as “bring your own device” (BYOD), helps create the opportunity to align more naturally with the patients’ life, creating a patient-centric data collection experience. For example, when sponsors adopt BYOD, patients can start recording data as soon as they download the app. With personal phones being integral to patients’ daily lives, eCOA becomes woven into their daily routines, giving them the flexibility to complete assessments anywhere. It also makes it less likely for patients to ignore reminders and alerts because of the common use of their own devices.

Implementing eCOA in the future

Sponsors will continue looking for more agile tools to enhance patient experiences, patient preferences, and data quality. Leveraging eCOA assessments creates a seamless opportunity for sponsors to capture COAs in a DCT model by capturing patient specific information to support the safety and efficacy of treatment and its impact on patients’ quality of life. Looking forward, gathering patient data using eCOAs and related apps will become a common and expected solution. The perks of implementing an eCOA strategy cannot be denied. eCOAs are instrumental in creating a holistic strategy that puts the patient at the center of care and increases operational efficiencies, data integrity, and compliance.

Anthony Mikulaschek is Vice President of IQVIA eCOA.