[A24-57] Routine practice data collection for risdiplam: Review of the study protocol (Version 2.0) and statistical analysis plan (Version 2.0) – Third addendum to Commission A21-131

Last updated 19.09.2024

Project no.:
A24-57

Commission:
Commission awarded on 06.05.2024 by the Federal Joint Committee (G-BA).

Report type:
Addendum

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Muscles, bones and joints

Note:

Routine practice data collection (RPDC): Review of the study protocol and statistical analysis plan

In the case of new drugs that have entered the health care system via a special marketing authorization or as a drug for the treatment of a rare disease, the study data at the time of marketing authorization are usually not very informative for the early benefit assessment. As in the present case, the G-BA can require the pharmaceutical company to collect routine practice data, including the associated analysis, for the benefit assessment. The pharmaceutical company has to submit a study protocol and a statistical analysis plan for the RPDC. IQWiG reviews these documents on behalf of the G-BA.

DOI:

https://dx.doi.org/10.60584/A24-57

Federal Joint Committee (G-BA)

2024-09-19 A G-BA decision was published.

G-BA documents on this decision

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