Vaccine trials bring time pressures that are very different to those associated with most other products within pharmaceutical development. Unique seasonal health concerns, as well as the need to fast-track studies to meet the challenges of rapidly-evolving disease outbreaks, mean every aspect of clinical trial execution must operate as efficiently as possible.
The traditional approach to collecting patient data in vaccine trials is through paper-based questionnaires and symptom diary cards. However, with vaccine programs involving large and diverse patient populations, manually processing these vast amounts of data can be costly, time-consuming and inefficient. Here, we look at how the latest electronic data capture solutions are helping to deliver safe and effective vaccines faster and more cost-effectively.
Electronic data capture enables rapid, cost-effective analysis
The demanding schedules associated with vaccine development mean that clinical trial data must be efficiently collected and processed. Yet, the large volumes of data associated with vaccine trials can present a significant operational challenge for paper-based workflows. A two-dose vaccine study based on an 11 question, 30-day diary involving 10,000 patients, for example, could produce 6.6 million individual data points (see figure 1). Physically storing, as well as manually processing, paper-based record cards can be a logistical struggle for sponsors and clinical trial site staff.
By automatically transferring data directly from the patient’s smartphone to the study database, electronic vaccine platforms bypass the need for physical storage of diary cards and eliminate the need for time-consuming data transcription and validation steps. This streamlined approach can significantly accelerate timelines, reducing the risk of not meeting first-patient-in (FPI). Moreover, with near-instant access to patient study data, investigators can analyze findings in real-time.
Electronic vaccine platforms safeguard data quality
Electronic data capture not only increases the speed of data collection, it also improves data quality. Unlike paper-based approaches, electronic vaccine platforms can ensure patients’ electronic diary (eDiary) card entries fall within specified parameters and time windows. Prompts and messages can also be sent to remind participants to record responses. These features can significantly reduce the occurrence of missing or erroneous diary entries, helping to ensure more consistent, reliable and accurate data.
Moreover, as data is seamlessly transferred from the user’s device to the centralized study database, transcription errors are eliminated. eDiary cards also provide a time-stamped electronic audit trail from entry to analysis, giving sponsors and regulators additional confidence regarding the data integrity. In this way, electronic data capture can significantly reduce the risk of a vaccine being rejected based on the traceability and attributability of patient data.
Pre-validated questions ensure streamlined study set-up
Large-scale vaccine trials can involve diverse patient populations spanning multiple geographical regions, requiring differing questions, and languages, appropriate to each patient group. Traditional electronic Clinical Outcome Assessment (eCOA) solutions require custom eDiary card development for each new vaccine study and can therefore add costly and time-consuming validation steps to study schedules.
Dedicated vaccine platforms, on the other hand, allow study diary cards to be delivered more rapidly by enabling questions to be selected from a pre-validated library. Diagnostic technology can also be employed to further simplify and accelerate study roll-out across different sites by automatically assigning the correct diary variant based on patients’ individual enrollment criteria.
A modern approach to vaccine trial data collection
With vaccine clinical trials involving demanding timelines and tight schedules, program sponsors need a robust and cost-effective approach to data collection. Electronic vaccine platforms overcome many of the limitations of traditional paper-based diary cards, helping to streamline clinical trials and deliver safe and effective vaccines to those who need them.