As a part of the patient participation program, CCMO has planned to include additional questions within the study protocol prepared for a study that would indicate if patients were involved in the conduct of the trial. It would apply to all national clinical trials.
More information regarding the patient participation program and the type of questions to be included within the study documentation would be available on the website on January 31, 2023.
- For drug research that falls under the CTR, the applicant would need to indicate if the study involves patients or not. If there is no patient participation, it would require additional justification.
- Also, the protocol must contain a summary in both Dutch and English. It is also mandatory to submit a lay summary of the study results, which will be made public via CTIS. Patients can also be involved in drafting these summaries.
- The CCMO will be organizing two information meetings about the importance of patient participation in research and the questions in the research file. During these online meetings, representatives of patient organizations and a researcher will present examples of their activities related to patient participation in research. More information could be found on this link.