New Oncologic Drugs from 2008 to 2023—Differences in Approval and Access between the United States, Europe and Brazil
Round 1
Reviewer 1 Report
Comments and Suggestions for AuthorsThank you for allowing me to review this article of significant importance which focuses on the New Oncologic Drugs from 2008 to 2023 - Differences in Approval and Access between the United States, Europe, and Brazil
The title is clear and coherent with the aim and content of the article.
Abstract
It would be important for the authors to briefly introduce the subject, highlighting the relevance of this article, as they begin by describing the objective.
Line 10-12 - This information can be at the end of the abstract, as the reader needs to focus on the content of the article, its background, objective, methodology, results and conclusions, and then if they are interested they can consult the link. If the reader is immediately referred to the link before reading the abstract, we can induce the reader to direct their attention to this link and instil a lack of interest in reading the article.
The authors didn't put keywords in their article. I recommend that they do.
Introduction
You should review the reference rules since in the text, reference numbers should be placed in square brackets [ ], and placed before punctuation; for example [1], [1-3] or [1,3]. See the rules at https://www.mdpi.com/journal/curroncol/instructions#preparation
The introduction is clear and concise, summarising the players in the US, Europe and Brazil and the importance of approval times and their impact on patients' lives. The objective of the study is clearly presented.
However, the introduction could benefit from including data from additional studies on the subject, providing a justification for the different approval times for medicines in various countries. It would also be beneficial for the reader to understand the necessary steps for drug approval, and whether these differences are related to safety issues or are merely bureaucratic and monetary. Justifying the varying approval times could enrich the introduction and offer deeper insight into the topic.
Methods
The methodology described in the article is clear and detailed, allowing for a complete understanding of the procedures adopted. The explanation of data collection, including the public databases used and the drug selection criteria, is well articulated. The inclusion of the dates of submission, start of the procedure and approval, along with the clinical indications and characteristics of the drugs, provides a solid basis for the analyses carried out.
It would be interesting to reflect on potential biases in data collection and analysis, such as differences in submission and approval criteria between agencies.
Results
The results section of your article is well-structured and provides a comprehensive analysis of the approval times for oncological drugs across different regulatory agencies.
Discussion
The discussion section reveals a pertinent interpretation of the results presented, mobilizing some explanations that could also have been used in the introduction to support the pertinence of this study. I think the most important thing to emphasize is the delay in approvals and the consequences that this delay has on the treatment or even death of patients. The authors recognize the limitations of the study, but it would be very interesting, given the results obtained, to propose some areas for further studies to reinforce the importance of speeding up and standardizing drug approval processes and thus contribute to greater equity in health and quality of treatment.
References
The references used are current and relevant to the type of study presented.
I want to congratulate the authors on this paper.
Author Response
Please see the attachment
Author Response File: 
Author Response.pdf
Reviewer 2 Report
Comments and Suggestions for AuthorsThank you for giving me the opportunity to review this article. The author conducted a study focusing on the approval of oncologic drugs. While the topic is socially important, there are methodological problems in the manuscript. Therefore, I believe the manuscript should be extensively revised before further consideration. My comments are listed below.
Comments:
1. The authors should use a language editing service before submitting the revised manuscript and upload the certificate as supplementary material.
Abstract:
2. The authors should correct the way they express numbers. For example, "n15" should be replaced by "n=15." They should check and correct the entire manuscript.
Methods:
3. How did the authors decide the study period (2008-2023)? Did they set any criteria to judge “peak period”?
4. The authors should clearly state the search formula used for each database.
5. The authors should add the data availability statement. If possible, they should upload the data to a repository.
Results:
6. The authors should transpose the rows and columns in Table 1.
7. The authors should include abbreviations and other notes as footnotes below the table.
8. There is no label for the vertical axis in Figure 1.
9. The use of “,” and “.” Is mixed up. The authors should use “.” for p-values.
10. How did the authors define "two distinct periods"? Isn't the setting of these two distinct periods arbitrary?
11. Are there any differences among drug classes and/or other features?
Discussion:
12. The authors should correct typos such as “[20]. [21, 22].”
13. This study only focused on the period, and the factors which affected to the results are totally unclear. They should discuss on this issue in detail as a limitation.
Comments on the Quality of English LanguageThe authors should use a language editing service before submitting the revised manuscript and upload the certificate as supplementary material.
Author Response
Please see the attachment
Author Response File: Author Response.pdf
Round 2
Reviewer 2 Report
Comments and Suggestions for AuthorsThank you for giving me the opportunity to review the revised version of this article. The author has made some corrections to the manuscript. However, I believe that the manuscript should be revised again before further consideration. My comments are listed below.
AR, authors’ reply; AC, additional comment(s)
Methods:
1. The authors should clearly state the search formula used for each database.
AR: Thank you for your input. First and second paragraph from section 2.1 were rewritten.
AC: The authors should cite references (3-5) again in the Methods section to improve accessibility to the data source.
Results:
2. Are there any differences among drug classes and/or other features?
AR: Thank you for your suggestion, such analysis were considered by the authors, however due to the great number of classes and primary site indication, the analysis would have no power to draw any conclusions. The only analysis that would have a sufficient number would be the division between oral and injectable drugs; however, the authors believed there would be no interest in this analysis.
AC: This can be a limitation, and the authors should discuss in the discussion section.
3. AC: The authors should add the unit to the horizontal axis of Figure 3.
Discussion:
4. This study only focused on the period, and the factors which affected to the results are totally unclear. They should discuss on this issue in detail as a limitation.
AR: Additional discussion topics were added – highlighted in the manuscript.
AC: The file “curroncol-3086509-peer-review-v2” only highlights the grammatical corrections. The authors should use a yellow line marker to highlight these parts. Additionally, the authors should discuss the limitations in more detail.
None
Author Response
Thank you for your additional comments.
I will reply them in order.
Comments 1:
The authors should clearly state the search formula used for each database.
AR: Thank you for your input. First and second paragraph from section 2.1 were rewritten.
AC: The authors should cite references (3-5) again in the Methods section to improve accessibility to the data source.
Response: References 11-15 were added, regarding the databases and the websites for procedural documentation
Comments 2:
Are there any differences among drug classes and/or other features?
AR: Thank you for your suggestion, such analysis were considered by the authors, however due to the great number of classes and primary site indication, the analysis would have no power to draw any conclusions. The only analysis that would have a sufficient number would be the division between oral and injectable drugs; however, the authors believed there would be no interest in this analysis.
AC: This can be a limitation, and the authors should discuss in the discussion section.
Response: Additional discussion topics were added, better explained at comment 4.
Comments 3:
The authors should add the unit to the horizontal axis of Figure 3.
Response: It was added.
Comments 4:
This study only focused on the period, and the factors which affected to the results are totally unclear. They should discuss on this issue in detail as a limitation.
AR: Additional discussion topics were added – highlighted in the manuscript.
AC: The file “curroncol-3086509-peer-review-v2” only highlights the grammatical corrections. The authors should use a yellow line marker to highlight these parts. Additionally, the authors should discuss the limitations in more detail.
Response: I apologize for any confusion. The file from the first revision I previously sent (as shown in the attached photo) has several corrections highlighted in yellow. The grammar corrections from the English editor are in blue or crossed out in the text. In the new file I sent, I highlighted again the discussion section that was modified, citing the limitations suggested in your first and second reviews. These are lines 347 to 357.
Thank you very much for taking the time to review the article. Please do not hesitate to suggest more topics in the discussion or limitations if you find it necessary. I remain at your disposal.
Round 3
Reviewer 2 Report
Comments and Suggestions for AuthorsThank you for giving me the opportunity to review the revised version of this article. The author has made corrections to the manuscript according to the comments. Therefore, it can be accepted for publication in its present form. For your information, the corrected parts did not appear as shown in the attached photo. There were no yellow highlights in the corrected manuscript that you provided in the previous round of review.
Comments on the Quality of English LanguageNone.
