Regulatory Science Network Nederland (RSNN) Expert Meeting – 23 June 2020
Results from an investigator-initiated study might indicate that a medicinal product is effective outside of the approved indication(s). However, this research does not always lead to an extension of indication, and also raises the question whether investigator-initiated studies can be used to support such a variation. The RSNN organised an Expert Meeting on 23 June 2020 to discuss the use of data from investigator-initiated studies to support an extension of indication. For this meeting, the Drug Rediscovery Protocol (DRUP) study was used as an example. A total of 23 experts and stakeholders participated in this meeting.
During the meeting, several aspects were discussed. First, the participants were asked to provide their opinion on whether there is a need to update the label based on data from investigator-initiated studies. Arguments for and against a label update were provided. Next, it was discussed which of the involved stakeholders is allowed to submit data to the agency. Of note, the involvement of a marketing authorisation holder (MAH) might be limited in investigator-initiated research, and the MAH is not the owner of the data. It was not completely clear what the possibilities were within the current regulatory system regarding this topic. Finally, the level of evidence necessary for an extension of indication was elaborated on.
At the end of the meeting several stakeholders indicated that they were interested in further exploring the possibilities concerning the use of data from investigator-initiated studies to support an extension of indication in the future.
Upcoming event: The Largest Consultation Hour on COVID-19
On November 5, the Medicines Evaluation Board will be hosting a YouTube-livestream event on the coronavirus, medicines and vaccines. Several experts will participate and discuss the latest developments and views on the future.
Guests include prof. Jaap van Dissel, Director of the Centre for Infectious Disease Control at the National Institute for Public Health and the Environment (RIVM) and prof. Diederik Gommers, chair of the Dutch Intensive Care Association. Both are members of the Outbreak Management Team (OMT). Prof. Miriam Sturkenboom, who was also interviewed for this edition of the Regulatory Science Magazine, will also take part in ‘The Largest Corona Consultation Hour in the Netherlands.’
Prof. Ton de Boer, chair of the MEB and also present during the livestream, emphasizes the importance of sharing more information:
“Until now, two medicines against the coronavirus have been approved, and review has started for the first vaccines as well. We understand that the public has many questions, so we find it important to provide the opportunity to ask questions to the experts.”
First virtual DIA Regulatory Science Forum
On 28-30 September the first DIA Regulatory Science Forum took place virtually. The Regulatory Science Forum provided a platform to share knowledge derived from regulatory science research and have an open dialogue between different stakeholders (academia, industry and regulators).
The first session started with the question: Why regulatory science research is important? In this session examples were explored on what major regions and stakeholders (such as the EMA and FDA, industry and academia) are doing to advance their priority topics in regulatory science research, and how that contributes to policy making and current practices/regulation. In subsequent sessions, the discussion focused on specific topics in regulatory science, such as complex clinical trials, nanosimilars, pharmacovigilance, and interface between authorisation and HTA.
Also special attention was paid to regulatory science training in one of the sessions. Regulatory science training examples at academia were highlighted from Portugal and Denmark. Also, joint university and agency training was presented by the Medicines Evaluation Board from the Netherlands. Lastly, an update on the STARS project was presented, as well as the Dutch EUPATI-training.
At the end of the three days, the last session focused on the next steps towards maximizing the value and impact of regulatory science research. As to the previous sessions, the discussion was very inspiring on how to move forward with regulatory science with involvement of all stakeholders (industry, academia, regulators, patients).