RSNN Expert Meeting Report - label modification based on evidence deriving from investigator-initiated trials

The meeting topic was data from investigator-initiated clinical trials, such as the Drug Rediscovery Protocol (DRUP), as a basis for an extension/amendment of the indication.
Twenty-three experts and stakeholders from various backgrounds were invited to discuss this topic. The following questions were addressed during the meeting:

• Can evidence from investigator-initiated clinical trials, such as the DRUP study, be used to support regulatory decision making (e.g. an extension of indication in Europe)?
• What type of evidence is required to support such an extension of the indication?
• What obstacles are there with regard to regulations when it comes to an extension of the indication (by the MAH) based on investigator-initiated data?
• Can evidence from investigator-initiated clinical trials, such as the DRUP study, be used to support the MAH(s) in subsequent steps in clinical research?

One of the main conclusions of the meeting that all participants agreed with was that data from investigator-initiated trials should not be lost.

Click on one of the links below to read the full report of the meeting:

• English version (pdf file)
• Dutch version (pdf file)