The Clinical Chronicler Nov 15, 2018
The Food and Drug Administration (FDA) announced the launch of its MyStudies smartphone app on November 6th, 2018. The app, aimed at collecting patient generated health data, is a first of its kind venture for the government agency.
As the field of clinical research moves ever forward into the digital age, researchers have integrated digital tools in modern trials to allow for easier and more accurate data collection. These tools foster a patient-centered atmosphere, where modern clinical trials can be shaped based on patient feedback.
FDA Commissioner Scott Gottlieb, M.D. outlined the goal for the new app in an official brief to the general media.
There are a lot of new ways that we can use real world evidence to help inform regulatory decisions around medical products as the collection of this data gets more widespread and reliable. Better capture of real-world data, collected from a variety of sources, has the potential to make our new drug development process more efficient, improve safety and help lower the cost of product development,” Gottlieb stated. “Our hope is that the collection of more real world data directly from patients, using a secure app, will lead to more efficient product development and assist with safety monitoring.
Gottlieb went on to explain the role of patient voice in the development of new clinical trials, and how the app will help inform not only patients, but their doctors as well.
If done right, it can also help make sure doctors and patients are better informed about the clinical use of new products, enabling them to make more effective, efficient medical choices. This will ultimately help us achieve better outcomes, and safer and more efficient use of expensive technology
finished Gottlieb in his address.
The MyStudies App was developed with assistance from Kaiser Permanente through a pilot study before being approved for release. The app can collect patient data from electronic health records, claims and billing activities, and product and disease registries, as well as allow for patients to generate their own data through other mobile health apps and in-home use. The app is intended to be fully customizable, with the intent for different sites to alter its functionality to fit their needs.
Although the app was developed privately by the FDA, Gottlieb stressed the intent of the app to be customized by policymakers and health IT developers for individual site needs.
This digital platform,” Gottlieb explained, “enables developers to adapt our technology to advance new ways to access and use data collected directly from patients—with the necessary controls in place to ensure patient privacy.
Though the functionality of the app has just started to be explored in the private sector, the FDA gave several examples of uses for the app. Patients could use the MyStudies app to discover new clinical trials and enroll in them remotely through the app. Sponsors can create patient-report questionnaires through the app to asses symptoms, medication use, and patient-reported outcomes for individual trials. All of this under the banner of the FDA’s regulations and guidance for data authenticity, integrity and confidentiality.
As of this article, the app has been released to the public as opensource code with technical documents to outline customization. There are no current clinical trials using the app, but that is likely to change as sponsors and sites utilize the app for future medical research. Technology like this app will be the key to a more patient-centered medical field in the future, and one of the best ways to ensure the patient’s voice is heard clearly in all clinical research.