Observational studies are a vital tool for gathering data regarding the effectiveness of treatments in the real world. They can be highly informative but should be “low touch”, meaning researchers have limited interactions with patients and must rely on information captured through the normal course of treatment and everyday life.
In this observational study, a global pharma company required a robust data capture solution to support a three-year, multi-faceted study of approximately 1000 respiratory (COPD and asthma) patients to track the effectiveness of a marketed product. This needed to provide both remote patient data capture and site-based data capture, including validated instruments, in Europe and North America.
Clario’s Post-Approval platform enabled site assessments to be delivered via provisioned tablets and remote assessments to take a bring-your-own-device approach. This meant patients could choose to use their own computer, smartphone or tablet to complete assessments. Importantly the remote data capture solution was able to provide the widest choice possible for patient participation by delivering simultaneously as an iOS app, Android app and web interface. By offering a multi-modal BYOD solution, with the added option of provisioning devices if necessary, potential technological exclusion criteria were removed to facilitate optimum patient enrollment.
Our client wanted to ensure that technology was not a barrier to patient participation. So when they saw we could deploy this system simultaneously across all platforms they were very impressed.Matt McCarty
Chief Strategy and Marketing Officer, Clario
The solution included multiple validated instruments, including a Visual Analogue Scale (VAS). To manage this, a minimum size requirement to access the VAS was incorporated to prevent access via unsuitable devices and ensure measurement validity.
Finally, each assessment (quarterly or annual) was only available for patients to complete during the designated time window. A message schedule was constructed which provided notifications to patients when assessment windows were open for completion.
By allowing patients to decide which device they’d like to use during the study and bringing the data collection process directly to them via the devices they use every day, participation was seamless and the patient burden reduced.
These choices helped to optimize enrollment rates and reduce patient drop out, while, at the same time increasing the quality and quantity of data collected.
To date, the study has achieved a steady rate of enrollment, and a high rate of on-time and in-full survey completion across all device platforms. The support team has experienced a very low rate of help desk calls and login queries, even in the early days of the study, suggesting the interface is intuitive and user-friendly. This is an important benefit, as early drop-out rates could be linked to frustration with cumbersome or confusing technology.
The study will also provide the sponsor with a cohort of patients for potential participation in future studies.