Prospects for clinical trials
They have been around for almost five years – and are now established and recognized: “apps on prescription”, i.e. digital health applications (DiGA). They monitor users’ health parameters or offer patients important support in dealing with their illness.
With increasing digitalization in the medical sector, the scope of mobile applications in medical practice is also constantly expanding. Although they are becoming increasingly important in the field of clinical studies, companies are often hesitant when it comes to concrete implementation.
The reasons for this include limited regulatory guidance and a lack of standards and implementation approaches. The lack of suitable resources for product validation and adherence to existing processes could also be possible reasons. (Walton MK, Cppelleri JC, Byrom B, et al., 2020)
Both the FDA and EMA support technological advances, but manufacturers who want to approve a DiGA on the European market are subject to strict regulatory requirements from the EU. In addition to regulatory guidelines, mobile applications in clinical use are subject to a number of other requirements in terms of safety and performance profile as well as data protection and cyber security. (Gelis, L., Stoeckert, I. & Podhaisky, HP, 2023)
But one thing is clear:
“Companies should not be put off by this, because sooner or later the advantages will outweigh the disadvantages. Continuous and efficient data collection and analysis using mobile applications can lead to more accurate and reliable results. At the same time, processes can be simplified and, for example, the duration of studies can be shortened.”
Miriam Schulze, CEO BAYOOMED
A holistic concept for clinical trials with DiGA
For the clinical study of an inhalation specialist, BAYOOMED developed an integrated system consisting of a mobile app connected to a nebulizer and an associated web portal. The aim was to precisely record, evaluate and graphically display the inhalation behavior of the test subjects. Within a very short time after inhalation, the users received feedback on how their inhalation was, how they could optimize the use of the inhalation device or when they should take their next inhalation.
Platform for broad use – MedicalOne Connect
Convinced of the future of mobile applications and DiGA in widespread study use, BAYOOMED developed the MedicalOne Connect platform, which can be adapted for the collection of study data depending on the indication and customer requirements. “We believe that this form of study concept will prevail and want to make it as easy as possible for our customers to implement it,” emphasizes Miriam Schulze.