FDA has recently taken action in the real-world evidence field by releasing a new health App: MyStudies App is a standardized digital platform where researchers can collect, organize and analyze a variety of data directly from the real-world environment.
The open source code and technical documents are now available: researchers and developers could arrange this tool, fitting their study requests. Moreover, this modifiable and personalized system guarantees that authenticity, integrity and confidentiality are observed according to FDA’s regulations.
This Health App offers a range of possibilities: patients can securely enroll in clinical trials, pragmatic trials, observational studies and registries; researchers can evaluate patient-reported outcomes or patient reports of prescriptions; it supports multi-site trials and it can be used for many therapeutic areas and health outcomes.
This huge amount of information is a valuable resource useful for the healthcare system considering that this is able to fill numerous missing data for clinical trials or other medical research.
It is also worth mentioning that the App gives the opportunity to deliver well-informed notes regarding the clinical use of new products driving doctors and patients to opt for better medical choices.
“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” said FDA Commissioner Scott Gottlieb, MD.