How should endpoints be selected for a clinical investigations of a DiGA under the fast-track procedure?

1. relevance for patients and clinical significance:

- The selected endpoints should be relevant for the patients in order to measure the actual benefit of DiGA in everyday life.

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2. measurability:

- The endpoints must be measurable with measurement instruments validated for this patient population in order to generate either subjective or objective data and provide comprehensible evidence of the effectiveness of the DiGA.

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3. comparison with standard therapy:

- The selected endpoints should make it possible to compare the efficacy of the DiGA with the current standard therapy. If at some point DiGAs become part of the standard therapy, comparisons with already listed DiGAs must be examined.

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4. duration of the study to measure a medical benefit or a patient-relevant structural and procedural improvement:

- A DiGA is prescribed for 3 months and, if necessary, for a further 3 months. The positive treatment effect must then also be demonstrated during this period. This poses particular challenges for the choice of endpoint and the associated measurement instruments.

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5. usability and acceptance:

- The endpoints should also capture the ease of use and acceptance of the DiGA by users to ensure that the application is easy to use and well received - by patients as well as healthcare providers.

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6. economic advantage:

- In order for a DiGA to be reimbursed by health insurance companies at a good price, additional costs should be able to demonstrate an economic benefit.

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7. medical needs:

- Ideally, a DiGA should address an unmet medical need so that there is a demand for the product later on.

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8. map target population:

- When evaluating the results of the clinical trial, the BfArM will check whether the so-called target population was actually represented in the study population, i.e. the corresponding ratio of gender and age distribution, among other things, compared to the actual disease group.

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The selection of endpoints in a clinical trial of DiGA as part of the fast-track procedure should therefore ensure that the evaluation is practical, patient-oriented and meaningful.