Peer Review History

Original SubmissionMarch 23, 2020
Decision Letter - Jed N. Lampe, Editor

PONE-D-20-07779

A Phase I Dose-finding Design with Adaptive Shrinking Boundaries and Incorporation of Historical Information -- Extensions of the Bayesian optimal interval (BOIN) design

PLOS ONE

Dear Dr. Pan,

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We look forward to receiving your revised manuscript.

Kind regards,

Jed N. Lampe, Ph.D.

Academic Editor

PLOS ONE

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3. Thank you for stating the following in the Acknowledgments Section of your manuscript:

'Pan's research was supported in part by the American Lebanese Syrian Associated Charities

(ALSAC). Yuan's research was supported in part by grants R01 CA154591, P50 CA098258,

and P30 CA016672 from the National Cancer Institute, National Institutes of Health.'

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Please thoroughly revise your manuscript for English grammar and spelling. It would be useful to have a native English speaker review the manuscript before it is resubmitted.

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

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Reviewer #1: Yes

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4. Is the manuscript presented in an intelligible fashion and written in standard English?

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Reviewer #1: Yes

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5. Review Comments to the Author

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Reviewer #1: Bayesian optimal interval design (BOIN) is a recently developed model-assisted method for phase I dose-finding trials. This design has been accepted as a popular design in this field due to its simplicity and desirable operating characteristics. In this paper, the authors extend the original BOIN design from two aspects: incorporate the prior knowledge and relax the fixed decision boundaries. Both of these two extensions are important since the 1st one could possibly improve the performance of the phase I trial if relevant prior information can be used and the 2nd is an interesting theoretical exploration of the original BOIN design.

For the 1st extension, the authors proposed an automatic algorithm for its pre-specification of the parameter setups, which makes the proposed method feasibly to be used in real practices. The simulating conclusions are expected, which demonstrates the proposed algorithm works well empirically.

For the 2nd extension, though the results are not so exciting, that is, only when sample size are large, the proposed aBOIN design performs better than the original version, this exploration is still worthy from my perspective since it literally gives a solidified support for robustness of the original BOIN design.

My only concern is that it would be better that the paper can be edited by a professional language editor since there are still grammatic and language inappropriateness.

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Reviewer #1: No

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Revision 1

Response letter is provided.

Attachments
Attachment
Submitted filename: Response-v1.pdf
Decision Letter - Jed N. Lampe, Editor

A Phase I Dose-finding Design with Incorporation of Historical Information and Adaptive Shrinking Boundaries

PONE-D-20-07779R1

Dear Dr. Pan,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Jed N. Lampe, Ph.D.

Academic Editor

PLOS ONE

Formally Accepted
Acceptance Letter - Jed N. Lampe, Editor

PONE-D-20-07779R1

A Phase I Dose-finding Design with Incorporation of Historical Information and Adaptive Shrinking Boundaries

Dear Dr. Pan:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org.

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Thank you for submitting your work to PLOS ONE and supporting open access.

Kind regards,

PLOS ONE Editorial Office Staff

on behalf of

Dr. Jed N. Lampe

Academic Editor

PLOS ONE

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