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

When selecting endpoints for a clinical investigation (clinical trial of medical devices) of a DiGA under the fast-track procedure, the following aspects should be considered:

• Clinical relevance of the endpoint: the endpoints chosen should be relevant to patients in order to measure the actual benefit of the DiGA in everyday life.
• Choice of endpoint: The endpoints must be suitable for demonstrating positive healthcare effects. This can be either the medical benefit or a patient-relevant improvement of structure and processes.
• 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.
• Comparison with standard therapy: The selected endpoints should make it possible to compare the effectiveness of DiGA with the current standard therapy of the statutory health insurance funds in Germany. If at some point DiGA become part of the standard therapy, comparisons with already listed DiGA must be investigated.
• Duration of the study to measure a medical benefit or a patient-relevant improvement of structure and processes: A DiGA is prescribed for 3 months and, if necessary, for a further 3 months. The positive healthcare effect must then also be demonstrated during this period. This poses particular challenges for the choice of endpoint and the associated measurement instruments.
• Economic advantage: In order for a DiGA to be reimbursed by health insurance companies at a favourable price, a high effect size should be demonstrated and, if necessary, additional costs should be compensated elsewhere in order to demonstrate an economic benefit.
• Medical need: Ideally, a DiGA should address an unmet medical need so that the DiGA is later prescribed; a meaningful endpoint should be selected for this purpose.‍

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

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