Evaluation study after provisional inclusion in the DiGA directory: Is one year sufficient for implementation?

In theory

If DiGA manufacturers cannot yet demonstrate the positive healthcare effect(s) of their DiGA based on a scientific study, this evidence can be provided retrospectively as part of a year-long (maximum) study. The prerequisite for this is a systematic user data analysis (pilot study) that shows that the DiGA can make a significant contribution to improved care and that the positive healthcare effect can be evaluated during the study period. The one-year study period begins when the Federal Institute for Drugs and Medical Devices (BfArM) announces a positive decision regarding the DiGA. Three months before the end of the study period (at the latest), submission of a one-off application can extend the study period by up an additional year.

In practice

As of June 06, 2024, 35 applications are permanently listed in the DiGA-directory. Of these, eleven DiGAs were included directly. 24 applications were, initially, provisionally included and demonstrated a positive healthcare effect during the study period. 20 manufacturers applied for an extension of the study period by three (n=1), four (n=4), five (n=2), seven (n=1), nine (n=1), ten (n=1), eleven (n=1) and twelve (n=9) months. Four manufacturers did not have to extend the evaluation period.

A total of 20 applications are provisionally listed in the DiGA directory. Of these, 9 DiGAs are currently in the first year of testing. The remaining 11 applications have extended the study period by three (n=1), ten (n=1), eleven (n=1) and twelve (n=8) months.

This means that, so far, most manufacturers who were in the study phase with their DiGAs have applied to extend the study period.

Our experience

The main challenge during the study period was recruiting the test subjects, which took more time than initially planned. Our experience shows that the year-long study period should be very well prepared. This means, for example, that all study-relevant documents (e.g. ethics application, declarations of consent) should already be prepared during the application review by the BfArM and study organizational processes (e.g. center recruitment, monitoring) should be organized to be able to start the study directly after the positive decision.??

In addition, a convincing presentation of the recruitment potential (e.g. planning of online recruitment, sufficient study centers, cooperation with medical societies) as well as a realistic schedule for the entire study implementation are important.

To successfully complete the study during the one-year trial period, it is essential that everyone involved works hand in hand. As a scientific institute, we can offer the entire research process in close cooperation with the Clinical Research Organization (CRO) GREENBAY research GmbH in a seamlessly planned and continuously coordinated workflow - from study planning and implementation, data analysis and reporting to the publication of the results in a manner appropriate to the subject and target group. Our DiGA expert Tonio Sch?nfelder will be happy to answer any questions you may have.?

The WIG2 Institute’s DiGA-FAQ addresses the questions that have been frequently asked in our previous collaboration with DiGA manufacturers.

DiGA-FAQ // Evaluation study // Question 1: Evaluation study after provisional inclusion in the DiGA directory: Is one year sufficient for implementation?

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