Registration of DiGA studies and publication of DiGA study results—what needs to be considered?

In Theory

The Federal Institute for Drugs and Medical Devices (BfArM) requires the registration of DiGA studies in a primary registry or in a partner registry of the World Health Organization (WHO) International Clinical Trials Registry Platform. The German Clinical Trials Register (DRKS) at the BfArM is named as a recognized primary registry for Germany. To transparently demonstrate that the selected procedure of the DiGA study was pre-specified and defined in advance, the publication of the final study protocol is also recommended.

The study results of the evaluation study must be published one year after submission of the study evidence to the BfArM. Initially, publication of the study results on the manufacturer's website is sufficient, but later publication in the study register is also recommended.

In Practice

As of 09.08.2024, a total of 55 applications are listed in the DiGA directory, of which 20 are provisionally listed and 35 are permanently listed. All DiGA manufacturers have registered the trial in a trial registry, with most manufacturers (n=45; 81.81%) choosing the DRKS. Seven applications (12.73%) were registered in ClinicalTrials.gov and three applications (5.45%) in the International Standard Randomized Controlled Trial Number (ISRCTN) registry.

All DiGAs have their own website where information is provided for patients and healthcare professionals. 17 DiGA manufacturers (30.91%) have published the study protocol for the trial study, of which twelve applications are already permanently listed. In addition, the study report for the trial study has been published for eight of the 35 permanently listed DiGAs (22.86%). 11 applications (31.43%) have been permanently listed in the directory for less than 12 months. Eight DiGAs have already been permanently listed in the directory for more than 12 months but have not yet published a study report.

For eight DiGA (14.55%) (HelloBetter Diabetes and Depression, HelloBetter Panic, HelloBetter ratiopharm Chronic Pain, HelloBetter Stress and Burnout, HelloBetter Vaginismus Plus, Invirto-the therapy against anxietyGegen Angst, Mindable: Panic Disorder and Agrorphobia and vorvida), both the study protocol and the study report have been published, six of which have also published additional study results. Except for HelloBetter ratiopharm chronic pain and Mindable: Panic Disorder and Agrorphobia, these applications have been permanently listed in the directory for at least 20 months.

Good to Know: Study registration

• The guidelines of the World Health Organization (WHO) advise recording studies exclusively in a WHO primary registry.
• A study may only be registered in a registry once it has been approved by an ethics committee in German or English.
• The sponsor is responsible for registration but can also delegate this task.
• Studies that have already been started or completed can be registered retrospectively, but retrospectively registered studies are clearly marked as such. It should be noted that many journals may not recognize this form of registration.
• Once registered, studies cannot be deleted.
• There are no costs for study registration.

Good to Know: Publications

• Reports on the studies conducted should be as detailed as possible, as an incomplete report does not allow distinctions between the shortcomings of the report and those of the study.
• The study report should be prepared in accordance with internationally recognized standards, such as those specified in the CONSORT statement (Consolidated Standards of Reporting Trials; www.consort-statement.org).
• The discussion of the results is an essential part of the publication that is often inadequately addressed. It is important to comprehensively discuss the clinical relevance or patient relevance of the results obtained and to compare them with the already published literature, as well as the results of applications already permanently listed in the directory.
• The costs of publishing the study results in a scientific journal vary depending on the journal selected.

As a scientific institute, we support DiGA manufacturers in the planning, implementation, and analysis of the trial study. We ensure that the preparation of the results meets the formal requirements of the Federal Institute for Drugs and Medical Devices (BfArM) and that they are in line with the Evaluationconcept for the DiGA-Fast-Track. Our staff will also support you in registering your study and providing the necessary documentation. The preparation of study protocols, results reports and scientific publications in specialist journals are also part of our service portfolio. WIG2 colleague and DiGA expert Tonio Sch?nfelder will be happy to answer any questions you may have.

DiGA-FAQ // Good to know // Question 4: Registration of DiGA studies and publication of DiGA study results – what needs to be considered?

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