Patient participation in the research file from 1 March 2023
As part of its Patient Participation programme, CCMO has developed a set of questions on patient participation that will be included in the research file from 1 March 2023. For the time being, patient participation is not mandatory, but if patients are not involved in the study, the submitter must justify this choice. Currently, the questions apply to all Dutch clinical trials. Information on the Patient Participation Programme and detailed information on the questions implemented in the research file will be available on the CCMO website from 31 January 2023. An English translation of the questions will become available as well. In the section of the CCMO website on patient participation, you will also find information on the Council of Subjects the CCMO plans to set up and information on increasing the role of subject members in the review committees.
Clinical Trial Regulation (CTR)
For research with medicinal products covered by CTR, you may use CCMO's English-language research protocol. In section 5.4, you are asked to indicate, as part of the study plan and design, whether patients are involved in the study. If patient participation has not been carried out, you are asked to substantiate this.
In addition, under CTR, the protocol should include a summary in both Dutch and English. It is recommended to write the Dutch summary in layman's terms. Also, under CTR, it is mandatory to submit a lay summary of the study results, which becomes publicly available via CTIS. Patients can also be involved in drafting these summaries.
Other research subject to WMO
For other research subject to WMO, the questions are included in the ABR form, to be submitted as part of a research file in ToetsingOnline. For the time being, this also applies to research covered by the Medical Device Regulation (MDR) or the In Vitro Diagnostics Regulation (IVDR).
The questions become only visible in the ABR form when you indicate that your research concerns Dutch research, i.e. 'monocentre research' or 'multicentre research only in the Netherlands'.
CCMO is organising two information meetings on the importance of patient participation in research and the questions in the research file:
- Meeting 1: Wednesday 8 February 2023 09:00-10:30.
- Meeting 2: Monday 13 February 2023 11:00-12:30.
During these online meetings, representatives of patient organisations and a researcher will present examples of their activities related to patient participation in research to give you more insight into how patient involvement takes place in practice. The meetings will be held in Dutch.
You may register for the meeting of your choice by 31 January 2023 at email@example.com stating your name and preferred date. CCMO will then send you the Webex link for the appropriate meeting.