Cancer, Clinical Trials, and Canada: Our Contribution to Worldwide Randomized Controlled Trials
, J. Connor Wells 1,2, Wilma M. Hopman 3, Joseph C. Del Paggio 4, Bishal Gyawali 1,2,3, Nazik Hammad 2, Annette E. Hay 5,6 and Christopher M. Booth 1,2,3,*Round 1
Reviewer 1 Report
Well written article, which will add to the Canadian Oncology literature.
Author Response
Point 1: Well written article, which will add to the Canadian Oncology literature.
Response 1: Thank you for your comment!
Reviewer 2 Report
This is an interesting study that aimed to investigate the methodology, results, and interpretation of oncology RCTs with Canadian involvement compared to RCTs from other high-income countries (HICs). English language is fine; I also suggest to check throughout the text for spelling errors and consistent use of abbreviations. The Methods section should be improved. A flow chart of study selection should be included, as well as a detailed list of inclusion and exclusion criteria for the studies. Also, statistical significance value in Table 1 should be added. The major strength point is represented by the accurate selection of studies; the main limitations, as explained in the manuscript by the authors, are the exclusive selection of phase III RCTs, and the impossibility to provide a separate analysis for studies that were led by Canada from those that were led by other HICs with Canadian involvement. If possible, this points should be improved. I would also suggest to include further discussion on the future direction and potential clinical applications (if any) of the results.
Author Response
Point 1: This is an interesting study that aimed to investigate the methodology, results, and interpretation of oncology RCTs with Canadian involvement compared to RCTs from other high-income countries (HICs). English language is fine; I also suggest to check throughout the text for spelling errors and consistent use of abbreviations.
Response 1: We have carefully reviewed for any spelling errors and ensured consistent use of abbreviations.
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Point 2: The Methods section should be improved. A flow chart of study selection should be included, as well as a detailed list of inclusion and exclusion criteria for the studies.
Response 2: The flow chart is already included as eFigure 1 in the supplementary section.
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Point 3: Also, statistical significance value in Table 1 should be added.
Response 3: This has been done.
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Point 4: The major strength point is represented by the accurate selection of studies; the main limitations, as explained in the manuscript by the authors, are the exclusive selection of phase III RCTs, and the impossibility to provide a separate analysis for studies that were led by Canada from those that were led by other HICs with Canadian involvement. If possible, this points should be improved.
Response 4: We have revised the Discussion to expand on this important point. Added “This limits our ability to specifically evaluate the research agenda of Canadian-led trials” to lines 286-287.
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Point 5: I would also suggest to include further discussion on the future direction and potential clinical applications (if any) of the results.
Response 5: We have revised the Discussion to further emphasize future directions. Added “This will require increased government investment in cancer research infrastructure to support high-impact clinical trials” to lines 250-251.
Reviewer 3 Report
The authors present an interesting review of the value/participation of Canadian centres in oncology clinical trials. The study is well conducted and the manuscript well written. I have only one minor modification/suggestion:
the authors mention that only 14% of positive studies involving Canadians had high clinical impact but they fail to report the comparator % for non-Canadian HIC studies? In general, many clinical trials are required to get one that has a big impact/improvement on outcomes .... it would be very important to compare the 14% with a baseline and not provide that % as a standalone 'poor' result.
Author Response
Point 1: The authors present an interesting review of the value/participation of Canadian centres in oncology clinical trials. The study is well conducted and the manuscript well written. I have only one minor modification/suggestion:
the authors mention that only 14% of positive studies involving Canadians had high clinical impact but they fail to report the comparator % for non-Canadian HIC studies? In general, many clinical trials are required to get one that has a big impact/improvement on outcomes .... it would be very important to compare the 14% with a baseline and not provide that % as a standalone 'poor' result.
Response 1: Thank you for your comment! This is an important point. We have revised the manuscript to address this issue. The correct figure for Canada is 13% (not 14%, we have corrected this in the manuscript); the corresponding figure for non-Canadian RCTs is 12% (added to line 178).
Round 2
Reviewer 2 Report
The Authors replied satisfactorily to all my comments.
