Patient and Patient Group Engagement in Cancer Clinical Trials: A Stakeholder Charter

Round 1

Reviewer 1 Report

This manuscript represents an important framework to enhance the patient and patient group engagement in clinical trial design, conduct and results reporting and to increase the public awareness of clinical trial research in general. 

Minor point: Figure one: should the word accessing in the title of this figure be replaced for engagement? The former word implies a consumer role; the latter a participant role.

Do the authors see any role of direct patient engagement in the analysis and primary interpretation of clinical trial data? 

Author Response

Please see the attachment.

Author Response File: Author Response.docx

Reviewer 2 Report

This article describes the development of a Charter for patient engagement in cancer clinical trials. It is always challenging to explicate deliberative processes, and I think overall the authors have done a good job, however there is jargon used which I don't believe will be familiar to most readers. For instance on lines 106-107 the authors state: "the draft Charter was socialized in 2018-2019 culminating with a state-of-the-art Sprint session using an agile methodology...". This sentence appears to be the crux of the methodology, yet it is described only summarily. I would suggest further elaboration is needed to explain was is meant by "socialized", "Sprint session" and "agile methodology" in this context, and what makes the Sprint session "state-of-the-art"?

One concern I have is that this entire project, and the entire "citizen science/participation" movement more generally, is based on the assumption that patient/patient group engagement is an unqualified good. The only critique the authors provide in the discussion relates to practical hurdles to making this happen. However, there are more fundamental problems with the concept that need to be explored.  For instance, citizen science/participation may potentially further politicizes the research enterprise. There is an assumption that patients and patient groups represent a homogeneous entity, yet there can be factionalism and power dynamics even among and between patient groups. For instance, the Chair of Australia's public medicines insurer recently warned of increased factionalism, competition and lobbying among patient groups and the potential for it to enhance inequities rather than resolve them. I believe a more critical reflection of potential negative consequences and limits of patient engagement in clinical trials would strengthen the article. One starting point could be a recent critique of citizen science in biomedical research published in the American Journal of Bioethics and titled “Citizen science and the politicization of epistemology”.

Apart from this lack of conceptual critique to balance out the optimism around patient engagement, I believe this is an important initiative and congratulate the authors on taking a collaborative approach to developing this Charter.

Author Response

Please see the attachment.

Author Response File: Author Response.docx