Patient registries are increasingly being utilized for post-marketing surveillance of pharmaceuticals as well as to monitor treatment outcomes and drive future clinical initiatives. Data collection and data management in clinical studies become increasingly more challenging as the complexity of the study and the number of patients increases. For large and long-term studies, utilization of electronic data capture (EDC) systems where most processes and visit scheduling are automated is a must to obtain accurate data in a timely manner.
With an increased focus on patient-centricity in research and treatment evaluations, electronic patient reported outcomes (ePRO) commonly known as patient diaries or clinical outcome assessments (eCOA) are becoming the standard for capturing data from the patient perspective. The widespread adoption of technology in our daily lives is making it easier than ever to collect real-time data directly from the patient, providing a number of options for the patients to conveniently submit their health and quality of life data.
Depending on the study design and data collection points, patients can complete diaries electronically either from the comfort of their own homes on their home computers, on their smart phones or tablets, or at the study center during their visits. We are involved in numerous studies currently where these methods are being utilized, providing the study investigators with real-time data from patients so they can stay up to date with their study progress and monitor patient compliance.
Utilization of Interactive Web Response (IWR) systems that the patients can access either from their own home computers or through Apps from other devices such as smartphones or tablets is a very cost effective solution to collect data from a large number of patients. It is significantly more effective from a convenience and cost perspective as it eliminates the costs associated with transcription from paper diaries, and extra time invested to resolve queries and out-of-range data that can be prevented with the use of an interactive system that automatically flags inappropriate entries.
A number of studies are benefitting from tablet-based data collection at sites when the study design incorporates patient diary collection as part of the study visit. The patients can complete diaries in the waiting room at the doctor’s office on a study tablet device where the interface is specifically designed for study use. An advantage is that the interface allows both the doctors and the patients secure access to complete study related tasks on the device, providing a reliable and cost-effective tool for data collection where one tablet can serve many patients at the site. We are currently utilizing this method in several ongoing studies, a good example being the COSMiC Study by Janssen Inc. The combination of registries we are involved with are currently investigating diseases in a wide range of patients from their early twenties to their late eighties. The results so far indicate that a properly designed tablet interface that is simple for patients to use can successfully conduct tablet based data collection from patients of all ages.
Overall, an electronic diary is a significant complementing feature to a patient registry because in the context of large studies, it provides numerous benefits over alternative paper-based data collection including more accurate data, timely results and consequently better decision making by the study team.
HealthDiary provides Electronic Data Capture (EDC), Patient Diaries (ePRO) and Patient Registry services to Biopharma and CRO organizations. To learn more about our services, please contact us today.