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Editorial Policies

Editorial Policies

Authors are expected to familiarize themselves with the editorial policies set forth below. These policies apply to all AACR journals and are intended to help ensure the integrity of the publication process and the research published in the journals.

Authorship

The designation and order of named authors is determined by the authors themselves, by policies at their institutions, or both. As a general guideline, listed authors should have contributed substantially to 1) the conception and design of the study, acquisition of data, or analysis and interpretation of data; 2) drafting of the manuscript or revising it for important content; and 3) final approval of the version submitted for publication. The precise contribution(s) of each author must be indicated at or before submission of a revised manuscript as described in Author Contributions below. AACR journals accept no responsibility for deciding matters of authorship.

A note about gift authorship: Gift authorship, in which a named author has made an insubstantial contribution to the research or article, is considered unethical and must be avoided. Examples of gift authorship include granting authorship out of perceived duty, respect, or friendship, or to a department head or other research leader due to their standing in relation to another listed author(s).

Author Responsibilities

A single named individual must be designated as the corresponding author for purposes of manuscript submission. This person is responsible for all communication between the authors and the journal and for ensuring that all authors have agreed

  1. to be authors;
  2. to be listed in the order specified by the submitting author;
  3. to the declared author contributions;
  4. to the declared conflicts of interest;
  5. to the manuscript's data;
  6. to the manuscript’s most current text;
  7. to the manuscript’s submission to the journal.

The corresponding author further affirms on behalf of all authors that no part of the manuscript is under consideration, in press, published, or reported elsewhere. If any changes in authorship are proposed after the manuscript is submitted (including the order of author listing), the corresponding author must provide the AACR Publications Department with signed documentation (Authorship Change Form - PDF) from each author on the manuscript, including those being added, removed, or rearranged in byline order, affirming that all the authors agree to the changes.

The corresponding author has the responsibility of ensuring that the results presented in the manuscript are an accurate representation of the data that was generated. The corresponding author is also responsible for providing all data to any requestors for at least six years after publication.

If serious problems with the work are identified, all authors have an obligation to notify the journal and correct mistakes or request retractions within the framework laid out at Corrections and Retractions.

Co-authors are immediately notified by email of any manuscript submission on which they are listed as an author. Each co-author is requested to review their contact information and has a responsibility to read all versions of the manuscript and respond to any requests from the corresponding author that are required for him or her to fulfill the duties of the corresponding author as described above. Each co-author may access the submitted manuscript files of each version of the manuscript and see the status of the submission.

Group Authorship

AACR publications follow the Council of Science Editors (CSE) Recommendations for Group-Author Articles in Scientific Journals and Bibliometric Databases. The submitting author must identify any group named as an author in the byline, all members of the group who take responsibility for authorship of the manuscript (named individual authors), and all members of the group who do not take responsibility for authorship of the manuscript but have contributed to the work that led to the manuscript (nonauthor group members). All named individual authors from the group must be named in either the byline or in an accompanying note and must sign copyright release forms. If the group is the only author, then the submitting author identified by name will assume the responsibilities of a corresponding author (see “Corresponding Author Responsibilities” above). This author's name and contact information will be presented as the corresponding author in a note on the title page. Nonauthor group members may be either unnamed or may appear in the acknowledgments or an accompanying note. If a consortium appearing as a named author has rules for authorship that are in conflict with these guidelines, the consortium rules are applied. It is understood that the author will supply a summary of such consortium rules at the time of submission.

Byline examples:

  • The XYZ Group (the group is the only author; all members of the group are authors and must be listed elsewhere in the article)
  • Author1, Author2; and the XYZ Group (the group is one of several authors; all members of the group are authors and must be listed elsewhere in the article)
  • Author1, Author2, and Author3; for the XYZ Group (the three authors are writing on behalf of the Group; the other group members are not authors and may be either unnamed or may appear in the acknowledgments or an accompanying note)
  • Author1, Author2, Author3; Author4 and Author5; for the XYZ Group, Author6, Author7. (Authors 4 and 5 are writing on behalf of the group; other authors are unaffiliated with the group)

 

Author Contributions

The corresponding author is required, upon submitting a revised version of their manuscript, to indicate the contributions of their co-authors. Each co-author is automatically notified of their stated contribution(s) and encouraged to contact the corresponding author to resolve any dispute concerning the contribution(s) attributed to them. The AACR journals use the CRediT taxonomy listed below and described in detail on the CRediT website. A person whose contribution is not considered sufficient for authorship may instead be mentioned in the article acknowledgments.

  • Conceptualization
  • Data curation
  • Formal Analysis
  • Funding acquisition
  • Investigation
  • Methodology
  • Project administration
  • Resources
  • Software
  • Supervision
  • Validation
  • Visualization
  • Writing – original draft
  • Writing – review & editing

 


 

Publishing Ethics

The AACR is a member of the Committee on Publication Ethics (COPE) and adheres to its guidelines concerning misconduct. Various processes are in place to identify and prevent publication of work in which scientific misconduct, such as that outlined below, has taken place. In no case will the AACR or the journal editors encourage misconduct or knowingly allow it to take place. If the AACR or journal editors are made aware of any allegation of scientific misconduct, these allegations will be dealt with appropriately.

Conflict of Interest

AACR journal policy requires that authors, reviewers and editors disclose upfront any relationships that they believe could be construed as resulting in an actual, potential, or perceived conflict of interest with regard to the manuscript in question. The authors are responsible for providing a detailed conflict of interest disclosure statement on the title page of their submission. If there are no conflicts, please include this statement on the title page: "The authors declare no potential conflicts of interest." To ensure that the editors and reviewers assigned have ready access, manuscripts will not enter the peer review process unless this statement is included. If the manuscript is provisionally accepted, each of the authors will be contacted and asked to complete an individual electronic conflict of interest form. Failure to complete the electronic conflict of interest form will delay acceptance of the manuscript. The AACR journals' policy represents a recognition of the many factors that can influence judgments about research data and a desire to make as much information as possible available to those reviewing the data. If a potential conflict of interest is disclosed, notification concerning the relationship will be published along with the article. Failure by any author to disclose a conflict that later comes to light could result in a ban on that author publishing in any AACR journal for a period of time, to be determined by the AACR based on the seriousness of the omission and efforts made to correct the published record. Please note that Editors-in-Chief of AACR journals who are also authors are recused from handling any aspect of the review process for those submissions.

Redundant Publication

By submitting a manuscript for consideration, the authors affirm that neither the submitted manuscript nor any similar manuscript, in whole or in part, other than an abstract, is under consideration, in press, published, or reported elsewhere. However, please see Online Postings below for exceptions to this policy. The corresponding author is responsible for attesting to the article's status in this regard on behalf of all authors via the online submission form and agrees to inform the editors of any change in status that occurs before the AACR journal manuscript has been formally accepted or rejected.

Any related manuscript by the listed authors that is in press or under consideration at any publisher and that contains information relevant to the manuscript under consideration at an AACR journal, must accompany the submission and/or the revised manuscript. The cover letter should contain a description of how the associated manuscript(s) is related to the current submission. Failure to submit copies of related manuscripts under consideration elsewhere may delay the review process and may be grounds for rejection. Please see individual journal instructions and contact the editorial office if there are any questions about this policy.

Presentation at Meetings

The AACR generally encourages presentation at scientific meetings of original results prior to publication in an AACR journal. Nevertheless, press coverage and presentation at scientific conferences can sometimes affect consideration of submissions. For example, reporting the main findings of a manuscript in the mass media can compromise the novelty of the work and thus its appropriateness for publication by the AACR. Therefore, authors should feel free to present their data at scientific meetings but should not intentionally seek media attention or give copies of the figures or data from their manuscript to any reporter. If a reporter attends an author's session at a meeting and writes a story based only on the presentation, such coverage will not affect consideration of the author's manuscript.

Online Postings

Posting of manuscripts on institutional websites or on recognized community preprint servers, such as bioRxiv, is permitted under our publication policy. Authors must retain copyright to such postings and are encouraged to contact the journal’s editors to discuss their specific manuscript if they have questions. Please note that the AACR does not support posting of editorial communications, revised manuscripts that respond to editorial input and peer review, or the final published version. If accepted, the author must acknowledge publication by providing a link to the published version from any previously posted versions of the manuscript as follows:

"This manuscript has been accepted for publication in [AACR Journal Title], which is published by the American Association for Cancer Research".

 

Confidentiality

All reviewers and editors are required to adhere to ethical guidelines that mandate strict confidentiality concerning all aspects of a submitted manuscript and its content. Manuscripts submitted for consideration for publication are privileged communications, and the status of the manuscript and any details regarding it are available only to AACR editorial staff, authors, and the editors and peer reviewers involved. AACR reserves the right to make manuscript information available in confidence for the purpose of investigating possible misconduct.

Embargo Policy

The AACR's Communications and Public Relations Department periodically sends out news releases regarding upcoming articles of interest. Upon request from a reporter, the AACR makes the full text of these articles available in advance of publication with the understanding that the embargo policy will be upheld. Embargo dates and times are stated on news releases sent by the AACR.

If an author's institution is planning to promote an accepted manuscript in one of the AACR journals, the author or institution should contact Richard Lobb, Associate Director, Communications, to determine embargo dates (Email: richard.lobb@aacr.org). Because the AACR journals publish accepted manuscripts "OnlineFirst" usually within days of acceptance, it is important to contact the Communications and Public Relations Department to coordinate publicity efforts as soon as possible, preferably during the revision of the manuscript. The online typeset article is considered the article of record, whereas the print issue follows as an archive.

Advanced release of material is intended for reporters only but may be shared with third parties, such as coworkers at the author's institution or organizations and experts in the field, for the purposes of obtaining expert opinion and commentary. The reporter is responsible for communicating and obtaining an understanding from the third party that the embargo will be honored and the advance material will not be further distributed without permission from AACR's Communications and Public Relations Department.

Reporters should credit the appropriate AACR journal as the source of the information in any reports. Reproducing content from the advance material for inclusion in reports requires permission from the AACR (see Copyright and Permissions).


 

Research Ethics

Author Misconduct

Identified occurrences of author misconduct such as plagiarism, self-plagiarism, or data/image reuse, manipulation, or falsification will be investigated and could result in rejection of the manuscript or retraction of the published article. In instances of rejection or retraction due to misconduct, the corresponding author’s institute and funding agency may be notified.

All manuscripts submitted after peer review are screened for text reuse against previously published works, including the author’s own, using a plagiarism detection system (iThenticate). All images are subject to automated screening for image duplication (Proofig) and checks for other forms of manipulation.

Animal Studies

The AACR and its journals are staunch supporters of the most humane treatment of animals in the conduct of scientific studies, and it is expected that investigators will adhere to widely accepted national standards such as the following:

Only those manuscripts that describe ethically conducted animal experiments will be considered and published, and the AACR reserves the right to reject manuscripts that do not follow accepted standards. In describing any experiments that entail the use of animals, authors must confirm that the studies in question have been approved by an Institutional Animal Care and Use Committee or other appropriate review board. This information must be included in the main manuscript; it is not acceptable to confirm approval in the supplementary data.

Authors are strongly encouraged to register animal experiments at the Animal Study Registry before beginning the study.

Human Studies

The AACR journals endorse the principles embodied in the World Medical Association Declaration of Helsinki and expect that all investigations involving humans will have been performed in accordance with these or similar principles. Manuscripts reporting human experimentation must include a statement that the studies were conducted in accordance with one of the following ethical guidelines:

  • Declaration of Helsinki
  • International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS)
  • Belmont Report
  • U.S. Common Rule

A statement that the human investigations were performed after approval by an institutional review board and in accordance with an assurance filed with and approved by the U.S. Department of Health and Human Services, where appropriate, is also required. Finally, manuscripts reporting biomedical research involving human subjects must include a statement that informed written consent was obtained from each subject or each subject's guardian. Exceptions to this requirement may be made if the institutional review board determined that this was unnecessary. In such cases, the authors should include an explanatory statement in the manuscript.

If the study is a clinical trial, the trial must be registered in an appropriate registry prior to the start of the trial (see Clinical Trials).


 

Corrections and Retractions

Corrections

If the journal is made aware of potentially serious errors in an article, these will be examined and corrected as appropriate. Corrections to articles after online publication will only be made for errors that compromise the scientific record, such as a mistake in an author’s name, or that substantially impact the meaning or interpretation of the data but that do not compromise the overall results or conclusions of the article. Corrections will not be made to articles more than six years after online publication, except under exceptional circumstances.

When a correction is determined to be inappropriate or infeasible, the editors may instead publish an Editor’s Note to alert the readership of their specific concerns about a published article.

New critical information or data acquired by the authors themselves or by others after acceptance of the manuscript but before approval of proofs cannot be added to the body of the article. Instead, an addendum may be appended at the end of the article, subject to approval by the Editor-in-Chief. Such an addendum must be kept extremely brief and may cause a delay in publication.

Retractions

In certain situations, it is necessary to retract an already published article. This may happen for many reasons, including but not limited to: duplicate publication, plagiarism, unethical research practices or when it is clear that the results or conclusions of a published article are unreliable due to misconduct or honest error. In instances of retraction due to misconduct, the corresponding author’s institute and funding agency will be notified, per COPE guidelines.

When serious concerns are brought to the journal’s attention but time is required to properly examine the claims, or for the authors’ institution(s) to conduct an investigation, the editors will often publish an editorial Expression of Concern to alert the readership to the concern while it is being investigated.


 

Availability of Materials and Data

Publication in an AACR journal is contingent upon the authors’ certification that all materials, data, and protocols described in the manuscript will be made available upon request, if the request is made within six years of publication. Data for which community-recognized, structured repositories exist should be deposited in an appropriate repository as described below in Data. Restrictions on availability of any of the components of a manuscript must be disclosed in the cover letter at initial submission. Investigators must exercise great care to ensure that data and resources involving human subjects, and materials derived from human subjects, do not identify original donors or subjects, either directly or through identifiers such as codes linked to the donors or subjects. These requirements are subject to amendment, as the need for disclosure is likely to change with evolving technologies. The journal will contact the authors' institution(s) in cases where authors do not follow policy.

Materials

Unique materials, such as cells, plasmids, antibodies, animal models, and computer programs that were used in the research reported and that are not available from commercial suppliers must be made available, either through the authors' laboratories or organizations or through an appropriate collection or repository and an accession number added to the manuscript. Examples of acceptable repositories are:

 

If materials are not submitted to a repository, they must be made available as long as they are being used in the authors' laboratory or available to the authors. Materials that are prohibitively difficult to obtain, propagate, or synthesize are exempt from this requirement. Authors are not required to share materials when requests are for intended commercial use. The requesting party may be responsible for any reasonable associated cost of supplying the requested materials.

Data

A requirement of publication in an AACR Journal is that all data sets that are analyzed in the manuscript must be available upon request to the Editors and peer-reviewers, and to the community at the time of publication. An appropriate Data Availability Statement must be added at the end of the Materials and Methods (or Methods) section in the main text of the manuscript prior to acceptance.

Certain data as described below, for which community-recognized, structured repositories exist, must be deposited in an appropriate repository no later than submission of a revised manuscript. Failure to do so may result in delayed acceptance and/or publication. For all deposited data, the accession number(s) must be included in the manuscript and the database record must be publicly accessible on or before the first online publication date.

  • All natural nucleotide or amino acid sequence assemblies including, but not limited to, new genome or protein sequences, SNPs, or CNVs must be deposited in one of the following databases as appropriate: Genbank, ENA, DNA Databank of Japan, Uniprot, dbSNP, dbVar, EVA, or another INSDC database. Engineered sequences or synthetic oligonucleotides are more appropriately reported in supplementary data.
  • Raw sequencing data from high-throughput sequencing should be deposited in SRA, EVA, or another INSDC database.
  • Data from studies investigating the interaction of genotype and phenotype in humans must be deposited in dbGaP or EGA.
  • Data about variation and its relationship to human health must be deposited in ClinVar.
  • High-throughput functional genomics data must be deposited in GEO (supported experiment types) or Array Express (supported experiment types). Microarray data must conform to the Minimum Information About a Microarray Gene Experiment (MIAME) guidelines. These guidelines include a checklist of information that should accompany each microarray submission.
  • Small molecule crystallographic data for newly reported molecules must be deposited in CCDC.
  • Data related to macromolecular biological structures (atomic coordinates and related data, such as structure factor amplitudes and intensities, and/or NMR restraints) must be deposited with the wwPDB.

Any data for which a publicly available database does not exist must be made available upon request and for a period of 6 years after publication. Requests for data are limited to those data sets described in the article. Authors may choose to make such data freely available online at unstructured generalist repositories such as figshare, Dryad, or Zenodo and include a link to it in their manuscript.

Authors of multi-omics manuscripts are encouraged to use the BioStudies database to link together all their deposits that have been made in structured and/or un-structured databases.

Authors reporting results of clinical trials are strongly encouraged to make their data available upon request through the global clinical research data sharing platform Vivli.

The use of the statement "data not shown" when describing unpublished results is generally inappropriate. Author-generated data should either be provided as supplementary data, deposited in an online unstructured repository with a link provided in the manuscript (see above), or any claim and reference to the data should be removed. Unpublished data from a non-author should be cited as "unpublished observation(s)" or "personal communication" and written permission from the source should be submitted with the manuscript.

Software and Code

If custom software or code was central to the described work, the code and actual or representative data should be supplied in a form that is suitable for reviewers and readers to fully assess and reuse. The AACR manuscript submission system, SmartSubmit, has been integrated with Code Ocean which allows authors to provide the data, code, and computing environments used in the analyses reported in their manuscript so that reviewers and readers can easily reproduce the data analyses. Authors are strongly encouraged to use this service and link to the generated “compute capsule” from their manuscript. Please see Improving Reproducibility for more details. If use of Code Ocean isn’t feasible for some reason, authors may instead provide access to their code using GitHub. If off-the-shelf software or databases were used in the work, please see Data Analysis and Reporting below.


 

Data Analysis and Reporting

The AACR endorses and follows the principles and guidelines as described by the NIH in Principles and Guidelines for Reporting Preclinical Research and encourages all authors to fully embrace the tenets of these guidelines. . To assist authors, the methods text of all submitted original research articles is transmitted to SciScore for an automated check of important elements related to experimental rigor and reporting of the resources used. Authors are strongly encouraged to use the SciScore report to ensure that key information related to reproducibility is included in their manuscript whether they are revising it for submission to an AACR journal or another publisher. More information can be found at Improving Reproducibility.

Statistics

Authors are required to include sufficient details of experimental design and statistical analysis for reviewers and readers to properly assess the presented results and conclusions. The sample size (n) for any data point must be stated and sufficient information provided about how this number was determined to understand the degree to which the measurements were biological or technical replicates. For very low sample sizes (n < 5) the individual data points should be plotted. Means may be indicated, but without error bars or confidence intervals.

For statistical results derived from sample sizes of 5 or larger, the following details must be provided in the legend:

  • The sample size (n) for each data point must be stated.
  • All statistical tests and error bars must be defined.

 

A statistical analysis section should be added to the Materials and Methods section whenever statistical analysis is performed. This section should include details of how sample sizes were determined if this information was not provided in the legend or main text. For statistical analysis of small sample sizes, authors should use tests suitable for small sizes and provide a justification for the test used. The following information should also be provided:

  • Indicate whether the samples were randomly assigned to the experimental control groups. If the samples were randomly assigned, then the methodology used should be described.
  • State whether experimenters were blind to group assignment and outcome assessment.
  • Describe the methodology used in determining the sample/group size needs. If no power calculation was performed, then provide a statement as to how the desired sample size was decided.

 

Images

The sections below detail important AACR editorial policies related to image data in manuscript figures. Please see Figures for specific formatting and best practice guidelines for figures.

Electrophoretic gels and blots
Include positive and negative controls, as well as molecular size markers, on each gel and blot. Loading controls must be run on the same blot used for the experimental samples. It must be explicitly indicated if different blots are used to present the data of a single experiment. If the same loading controls or other data are shown more than once, this duplication must be explicitly stated and a rationale provided. The methodology used to probe a set of samples with multiple antibodies must be described. State whether multiple independent blots were used or the same blot was probed repeatedly. If multiple blots were used to represent one experiment, a description of how the independently generated blots were normalized must be included.

Vertically sliced gel images must be clearly separated using empty space or a black line. Image cropping should not be used to eliminate additional signal (specific or non-specific) from the results. Cropped blots should retain at least 6 bandwidths above and below the band. Uncropped versions of any cropped gels or blots must be submitted as supplemental data (for review purposes only).

High-contrast gels and blots are not acceptable, as overexposure makes the data non-quantitative and may mask additional bands. Use exposures with gray backgrounds. If a high-contrast, overexposed blot is required to accurately reflect all the data, then multiple exposures of the same blot should be included as supplementary data.

Image acquisition and analysis
All image acquisition tools (microscopes, objective lenses, cameras, detectors, etc.), software and any image-processing methods, including digital confocal or other image deconvolution methods, must be described in the Materials and Methods. It is the author's responsibility to exercise discretion during data acquisition, where misrepresentation must be avoided. Acquisition of images for comparative purposes must be standardized.

Specimen areas should be selected that objectively represent the critical features being presented. Images should be captured in an uncompressed format such as TIFF, and authors should retain unprocessed images and metadata files, as Editors may request them to aid in manuscript evaluation. If unprocessed data are unavailable, manuscript evaluation may be delayed until the issue is resolved.

Files that have been adjusted in any way should be saved separately from the originals, also in an uncompressed format. Only unprocessed original files should be used for analysis. If data are presented that include mathematical representations of pixel intensities and locations, the original unprocessed files must be provided for review. A scale bar must be included in all images except those for which scale is irrelevant, such as gel blots. Authors must state in the figure legend whether an image is a representative example.

Image composites
The grouping of images from different source files or regions from the same source file must be explicit, both by the arrangement of the figure and in the text of the figure legend. If clear separations are not included, they will be added by our production department, resulting in potential publication delays. Combining images taken at different times and different experimental conditions should be avoided. However, if this is the only way to present the data, the legend must include an exact description of the distinct experiments represented in the combined images.

Figures presenting merged color images from fluorescence originals must include the original single-channel images used to make the merged file, preferably displayed in grayscale to avoid limitations in visual perception of color intensities. Original single-channel images are ideally laid out in sequence as part of the figure but may be provided as supplementary data.

Multiple images may be combined into a single photomontage when the area of interest cannot be captured in a single image. In such a case, all images that make up the montage must be captured using the same method. Each smaller image should overlap its neighboring image by one quarter of the shared field in each direction. The outer boundary of the combined image must be clearly delineated. Any post-processing must be done on the total combined montage.

Image manipulation
AACR is a member of the Committee on Publication Ethics (COPE) and ascribes to the Principles of Transparency and Best Practice in Scholarly Publishing and images are expected to be compliant with our guidelines as well as those of COPE. Detection of images that do not adhere to these guidelines could impact the manuscript’s acceptance and may result in production delays. The authors should be prepared to respond to requests for source data within 7 days.

Publication in AACR journals is contingent on the minimal use of image adjustment, and the final image must remain representative. If pseudo-coloring is used, an image key must be provided next to the image. Adjustments of brightness, contrast, or color balance are acceptable only if they are applied to the whole image and as long as they do not obscure or eliminate any information present in the original, including background. Nonlinear intensity or color adjustments or alteration to specific features within the image are generally not acceptable. If any such image adjustments have been made, the details must be included in the legend and original, unprocessed files provided for comparison. The final image must be a valid representation of the original data and conform to all current community standards as detailed in the NIH Principles and Guidelines for Reporting Preclinical Research.

Clinical Trials

The AACR journals have implemented the World Health Organization (WHO) definition of clinical trials for all trials that began enrollment on or after January 1, 2009. This definition states that a clinical trial is "any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes." For more information, see the revised guidelines of the International Committee of Medical Journal Editors (ICMJE), Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals.

Study guidelines
In accordance with these overall guidelines, the authors must follow the guidelines that are specific for study design in their manuscript as listed below.

  • CONSORT for randomized trials
  • STROBE for observational studies
  • PRISMA for meta-analysis and systematic reviews
  • STARD for diagnostic accuracy

 



Trial registration
The AACR journals require, as a condition of consideration for publication, that all clinical trials be registered in any of the primary registries that participate in the WHO International Clinical Trial Registry Platform (ICTRP), such as those listed below.


Registration only in a partner registry is insufficient. Trials must be registered at or before the onset of patient enrollment. Whether the trial is the subject of the manuscript or the author refers to other trials in the text, the registration number should always be included so that a link can be generated from the published article to the trial record in the appropriate database.

   Examples:
      Trial registration ID: NCT00404079
      Trial registration ID: ISRCTN51857546



Trial data
Clinical trial data must be made available upon reasonable request. The AACR journals strongly recommend using the global clinical research data sharing platform Vivli to manage this process.



Study representation of underserved communities
Racial and ethnic minorities and other medically underserved populations are historically underrepresented in clinical trials. The AACR has recommended that clinical trial design be modified to require inclusivity, reduce barriers for patient enrollment, and reach a broader patient population. (See the AACR Cancer Disparities Progress Report for additional recommendations regarding clinical trials.)

To allow physicians to evaluate the applicability of trial results to their own patient population, the AACR journals require the inclusion of a table in the Supplementary Data that provides background information on the cancer under study and the representativeness of the study population. Patient characteristics that must be discussed are: sex/gender, age, race/ethnicity, geography, and other considerations that could impact the representativeness of the study population. An example of the required table is displayed below.

Supplementary Table 1. Representativeness of Study Participants
Cancer type(s)/subtype(s)/stage(s)/condition Triple negative breast cancer (TNBC)
Considerations related to:
Sex TNBC, as all other subtypes of breast cancer, is a predominantly female disease and is rare in men. Male breast cancer represents only between 0.5 and 1% of all breast cancers diagnosed each year. TNBC incidence is around 10-15% among all breast cancer subtypes in the overall largely female population, but its incidence in males is lower (4%) when compared to the other subtypes.
Age The median age at the time of all breast cancer diagnoses is around 63, while in TNBC it is closer to 57.
Race/ethnicity In the USA from 2014 to 2018, the overall breast cancer incidence rate was 127.1 cases per 100,000 among Black women and 132.5 cases per 100,000 among White women.

In Connecticut, the incidence rate of TNBC among Black women is 128.7, slightly higher than the national average.

TNBC accounts for 27% and 16% of breast cancers in premenopausal Black and White women, respectively, and 15% and 9% breast cancers in postmenopausal Black and White women, respectively.
Geography In the US, about 287,850 new cases of invasive breast cancer were diagnosed in 2021 and about 43,250 women die from breast cancer. In Connecticut, around 3,062 new cases were diagnosed in 2021 with approximately 492 breast cancer deaths.
Other considerations In large, randomized breast immunotherapy trials in which race/ethnicity are reported, the percentage of Black population is well below 13.4%, which is the US population average of Black individuals. Underrepresentation in trials limits evaluation of the impact of racial/ethnic- or ancestry-based differences in efficacy and toxicity.

The breast cancer death rate among Black women surpassed that of White women in the mid-1980s and continued to increase until the mid-1990s after which it started to decline in parallel in both groups. However, the 5-year relative survival rate for all subtypes of breast cancer diagnosed during 2011 through 2017 was still lower, 82% among Black women versus 92% among White women.
Overall representativeness of this study The age distribution of our study is similar to the average age distribution of TNBC in the literature, median age of 51.

By adding an accrual extension phase to our study, open for Black patients only, we increased the percentage of Black patients to 31%, which is proportional to the Black population size in the city of New Haven, Connecticut according to the July 2021 US census. Our study population was limited to our institution’s main site in New Haven, CT, and its satellite sites throughout CT.

As breast cancer in rare in men, no male TNBC patients were recruited, although this was not an exclusion criterium.

Antibodies

Authors must provide a citation along with unique identifying information (RRID (see Data Analysis and Reporting above), catalog number, clone number, etc.) for previously characterized antibodies. For antibodies that are less well characterized in the system under study or experimental protocol, the authors are required to provide a detailed characterization that demonstrates not only the specificity of the antibody but also the range of reactivity of the reagent in the assay, which will be published as supplementary data.

Chemical Compounds

Use the approved terms and abbreviations for chemical substances recommended by the International Union of Pure and Applied Chemistry (IUPAC). The exact chemical structures (and not simply the chemical names) of any unpublished synthetic, low-molecular-weight chemical compounds used as part of the described research (including clinical studies in humans) must be disclosed. For novel structures whose synthesis has not yet been described, the step-by-step synthesis details and product characterization data must be included in the supplementary data. For previously reported structures, accurate references must be provided in the manuscript. Any references or patents cited that provide the synthesis of compounds should specifically identify the exact molecules that are studied in the manuscript; general references to patents are not sufficient.

Cell Lines

AACR requests that authors confirm the authentication of all cell lines used in the research reported in its journals. Please also include the RRID (see Data Analysis and Reporting above) for each cell line used. If cell lines were used, a statement addressing the following points must be included in the Materials and Methods section of the manuscript:

  • From where and when the cells were obtained.
  • A description of the cell authentication and Mycoplasma testing method(s) and regimen used by the laboratory and, minimally, the latest date the cells were tested. If no testing was done, this must be stated.
  • The general length of time or number of passages between collection or thawing and use in the described experiments. This can be expressed as overall ranges.
  • The biological sex of the cells.

If cells were obtained directly from a cell bank that performs cell line characterizations and passaged in the user's laboratory for fewer than 6 months after receipt or resuscitation, re-authentication is not required. In these cases, the author should include the method of characterization used by the cell bank. Obtaining cell lines from colleagues or other institutions without authentication is strongly discouraged. Resources for authors regarding the cell line policy are available on our Improving Reproducibility page.

Animals

In experiments involving animals, the authors must confirm that the experiments were executed in compliance with institutional guidelines and regulations and after approval from the appropriate institutional review board (see Animal Studies). Approval numbers identifying the protocol should be included and the authors should adhere to the ARRIVE guidelines. All details concerning sex, age, weight, strain, sub-strain, and source should be described. Please also include the RRID (see Data Analysis and Reporting above) for each organism used. The genetic crosses that were used to generate the experimental and control population should also be described. Strain information should be included in the Materials and Methods section. In descriptions of genetically engineered animals, the source and strain of the embryonic stem (ES) cells should be included, along with details on whether the animals were maintained on the original background (isogenic with the ES cell genetic background), maintained on a mixed strain background, or made congenic onto another strain. In addition, the genotype of all experimental and control groups must be specified. Authors should follow the naming conventions outlined in Montoliu L, Whitelaw CB. Transgenic Res. 20:435–40 (2011) —PDF(206KB). A summary is provided by the International Society for Transgenic Technologies.

As described above in the Statistics section, justification of sample size must be included along with exclusion and inclusion criteria. The total number of animals used in each experiment and in each group must be provided. How the animals were distributed among/between the different groups should be included (whether the animals were randomized or not).

Gene Nomenclature

In addition to the use of common names, authors are required to include the approved nomenclature at the first mention of any gene or protein described in their manuscript. Inclusion of the approved nomenclature minimizes confusion, enhances discoverability, and makes it possible for the journal to provide links to the genome databases in the online version of the article. For example, the incorrect, but commonly used names for Cdkn1a include Cip1, p21, Waf1, and Sdi1. In addition, p38 can ambiguously refer to several different genes, including Ahsa1, Grap2, Syp, and Aimp2, as well as Mapk14. All gene names, whether approved or common, must follow the correct format guidelines: italicized and all upper case when referring to human genes; and italicized and first letter upper case and the remainder lower case for mouse genes. Complete nomenclature instructions can be obtained from the following organism-specific genome websites. If no approved gene name exists, the authors must obtain an approved gene name from the appropriate committee or other resource as described on those sites.

 

Formatting of protein names are the same as the gene symbol, but not italicized and in all upper-case letters, regardless of organism.

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