In an earlier installment to this series, we focused on scenarios where it’s critical to capture endpoint data electronically rather than on paper. For example, in studies where the data supports a primary endpoint or assesses suicidal ideation, as well as when the study design requires patients to complete daily assessments or integrate data with another data source.
Here we address other scenarios where the use of eCOA for capturing patient data is recommended and how clinical trial sponsors can reap the many benefits electronic data capture provides.
Regulators are now requesting more information about drug efficacy in oncology clinical trials beyond survival1. As survival alone does not provide the full picture of therapeutic benefit, regulators are recommending that the patients’ quality of life, such as symptom relief, pain and rescue medication use, and social/personal impact be key secondary endpoints in oncology trials. Electronic capture of these key secondary endpoints is not only recommended by regulatory agencies when submitting label claims, but will decrease missing data, increase compliance, and is preferred by patients (Figure 1). Furthermore, clinical research has found that health-related quality of life and overall survival are improved in oncology patients completing eCOA2.
Large scale clinical trials
Errors introduced on paper can be exacerbated in studies with large numbers of patients and sites, resulting in significant delays and costs due to data cleansing and processing. With eCOA, large volumes of data can be accurately captured and processed in real-time, eliminating burdensome, manual data entry and significantly reducing the need for data clarifications, which keeps your trial on track and on budget.
Daily diaries in phase I and II
When primary endpoints for phase I and II clinical trials include reporting of symptoms that are either common (everyday occurrence) or complex, eCOA is recommended. When symptoms are common, it is easy for patients to forget to record every instance (e.g.., voiding, stools).
Electronic diaries increase compliance and accuracy of reporting these common symptoms by incorporating alarms and evening reminders. In addition, some indications require more complex diaries, such as a bleeding diary where multiple bleeds can occur simultaneously, or a seizure diary where defining a seizure type can be difficult. For more complex diaries/event reporting, electronic data capture with branching technology simplifies event reporting, thereby increasing data accuracy and the likeliness that patients or caregivers will take the time to report symptoms.
The examples presented above are only a sample of scenarios where it’s recommended for researchers to use eCOA, based on its significant advantages over traditional paper assessments. The quantifiable benefits of eCOA are becoming widely acknowledged as its adoption continues to expand. For example, eCOA administration is an efficient use of time and resources — and technologies that reduce researchers’ time while reducing the risk for data errors invariably benefit the patient. And, patients prefer eCOA over paper-based assessments. By leveraging familiar modalities such as smartphones, tablets and browsers patients can easily complete COAs, enabling sponsors to minimize the costs and potential for errors typically seen in paper-based studies.
- Food and Drug Administration, FDA. 2018. Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics, Guidance for Industry.
- Basch E, et al. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. Basch E, et al. Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. 2017 Jul 11;318(2):197-198. Denis F, Basch E et al. Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer. JAMA. 2019 Jan 22;321(3):306-307.