Planning for effective patient data capture is an important aspect of vaccine trial preparation. Here we review how taking a platform approach to electronic diary (eDiary) card delivery can improve data quality and accelerate vaccine studies.
Help meet first-patient-in
Vaccine studies involve time pressures that are created by unique seasonal heath concerns and the need to fast-track studies during outbreaks such as the Zika virus. Study teams often use paper diary cards to collect patient data as this approach is seen as a fast and cost-effective way to meet first-patient-in (FPI). However, the back-end costs resulting from paper diaries are huge, and the data transcription and validation required throughout the study places a significant strain on site teams and jeopardizes data quality.
Vaccine study sponsors need not fret, as electronic Clinical Outcome Assessment (eCOA) solutions are overcoming these patient data collection challenges and ensuring study timelines remain on track through configurable data capture platforms.
These platforms use libraries of pre-validated questions for each study, based on the organization’s set of standards and including options for different patient groups and languages. This can speed up the delivery of eDiary cards by 75%, streamlining study timelines and minimizing the risk of missing FPI deadlines.
Enhance patient data quality and reduce costs
Using paper diary cards requires significant resources to manually transcribe and verify the enormous amounts of data generated by vaccine trials. For example, a two-dose vaccine study of 10,000 patients could produce a staggering 6.6 million data points (figure 1).
With paper diary cards, every single point of data collected needs to be manually reviewed and entered into the trial database by site or sponsor staff. Not only is this costly, but it increases the risk of data errors/omissions, which can significantly reduce data quality.
Electronic vaccines platforms enable automatic data transfer into a database (removing the need for manual data entry and validation) and provide a full audit trail. This not only reduces back-end costs and close-out delays, but ensures high quality data, decreasing the risk of a vaccine being rejected by regulators.
Secure electronic vaccines platforms also enable patients to enter data on their own smartphones. When suitable, this ‘Bring Your Own Device’ (BYOD) approach offers many advantages; for patients, who are most comfortable using devices they’re already familiar with and for sponsors, who recognize significant savings compared to provisioning separate electronic devices.
Improve protocol compliance
Multi-dose vaccine studies can be complicated, often running over an extended period of time and requiring patients to attend additional site visits to complete their vaccination course. A BYOD approach to eDiary data collection can simplify the process and improve patient engagement and protocol compliance in vaccine studies through prompts and notifications about when the next dose is due.
In vaccine studies, timing is critical. Despite the many benefits it delivers, electronic data capture is not typically used for vaccine studies, due to misperceptions of the time required to deliver validated eDiary cards. However, by leveraging the efficiencies of a configurable, electronic vaccines platform, sponsors can benefit from the significant data quality advantages without impacting clinical development timelines.
Download the eBook, ‘Improving Patient Data Capture in Vaccine Studies,’ to learn how an electronic vaccines platform can benefit your next vaccine study.
Tim Davis is the Vice President of Digital Patient Solutions at ERT