Sample chapter

In Germany, the patient experience data is fixed before Phase 3 clinical trials begin

Download the Germany chapter from the European Patient Evidence Navigator: the patient experience data G-BA expects, what the Medical Research Act changes for trial inclusion, and the 2025 to 2026 shift you need to plan for.

Patient Experience Data Germany Guidelines

Germany's G-BA operates the most demanding patient experience data expectations in Europe. Patient-relevant endpoints are mandatory, and the PRO instruments that carry them have to be selected, validated and powered before Phase 3 begins, not added once the trial is running.

Two shifts that came into force in 2025 raise the stakes: the EU HTA Regulation now feeds a Joint Clinical Assessment into G-BA's deliberations, and the Medical Research Act reshapes how and where German trials can recruit. Miss either and you are planning evidence you cannot use.

This chapter maps what G-BA expects, what the new rules change, and where the decisions have to be made, so your evidence is built to count.

In this chapter you'll find:

The regulatory bodies that decide what: BfArM, G-BA, IQWiG and the new specialised ethics committee

The patient experience data G-BA requires, and why PRO instruments must be locked before Phase 3, not after

What the Medical Research Act changes for trial inclusion, including the DCT provisions that open community and home-based recruitment

How the EU Joint Clinical Assessment now feeds G-BA, and the dual-evidence package sponsors have to plan for

The one 2025/2026 change that puts sponsors who ignore it at a recruitment disadvantage