Vist et al (2008) have attempted to answer this question by comparing people who participate in a randomised with their counterparts who did not take part in a particular trial. Whilst longitudinal follow-up of participants was possible for trial volunteers, such data was not readily available for people who did not participate.
Patient and the public involvement in research, known as PPI, is very topical at the moment. Getting PPI right is neither simple or something that can be done without careful thought. There are logical points in the evolution of a research project that lend themselves to active involvement of patients and the public – these are:
- Formulation of the research question – is the question relevant to the population? Will the result be applicable to the population studied?
- Prioritisation of the research – is this the most important question to address in the study population? Will people want to take part?
- Research design – is the study feasible as planned? Can a sufficient number of people be recruited?
- Research conduct – how are people recruited? Are the study materials promoting participation? Can the design be simplified?
- Research outcome – how can the results be rapidly translated into practice? How does this study matter?
No single PPI exercise can check all of these boxes, but instead, patients and the public need to be engaged at the different stages of the research process. Deciding on the research question along with prioritising it is something that needs to happen early on, while matters to do with the conduct of the research can wait until the question is already formulated.
Ethics committees play an active and vital role in PPI, particularly in the aspects related to research design and conduct, but this is often overlooked as being separate from active patient and public involvement. This is not the case as ethics committees are formulated to promote discussion and dialogue between expert researchers and the members of ethics committees who represent patients and the public. These interactions are some of the most productive discussions and take place within the context of the ethical review of the project. Of particular note, is the process of ethical review of the participant information sheet and consent, which forms the central part of the request to participate and, as such, these discussions at the ethics committee are some of the most productive.
One aspect of ICH-GCP that appears to be lacking is proper recognition of the need for patient and public involvement in research. As has been pointed out previously, ICH-GCP still refers to research “subjects” rather than the correct term of “research participant.” Active involvement of patients and the public both early on and throughout the research is not a guarantee of success, but at the very least, it puts the research in a context that people should wish to participate if given the opportunity. Ethics committees play a vital role in this process and this should not be overlooked.
ICH are meeting in Montreal this week. Our letter to them clearly outlines the steps required to make it much easier to do randomised trials.
The starting point is to develop a new guideline on the key principles to do a randomised trial well which is developed by all key stakeholders in a transparent manner.
Download our letter here:
ICH’s recent reflection paper “GCP Renovation” and the invitation to comment on the process laid out for modernising ICH-GCP and other related trial guidelines is to be welcomed. MoreTrials will send comments by the deadline of 11th March after we have discussed as a collaboration how we should respond.
What follows therefore is my own personal viewpoint having just read what ICH are proposing. [Read more…]