Information for Authors

Editorial Policy

The ASA’s new journal, Statistics in Biopharmaceutical Research (SBR), will publish articles that focus on the needs of researchers and applied statisticians in biopharmaceutical industries; academic biostatisticians from schools of medicine, veterinary medicine, public health, and pharmacy; statisticians and quantitative analysts working in regulatory agencies (e.g., U.S. Food and Drug Administration and its counterpart in other countries); statisticians with an interest in adopting methodology presented in this journal to their own fields; and nonstatisticians with an interest in applying statistical methods to biopharmaceutical problems.

The journal accepts papers discussing appropriate statistical methodology and information regarding the use of statistics in all phases of research, development, and practice in the pharmaceutical, biopharmaceutical, device, and diagnostics industries. Articles should focus on the development of novel statistical methods, novel applications of current methods, or the innovative application of statistical principles that can be used by statistical practitioners in these disciplines. Areas of application may include statistical methods for drug discovery, including papers that address issues of multiplicity, sequential trials, adaptive designs, etc.; preclinical and clinical studies; genomics and proteomics; bioassay; biomarkers and surrogate markers; models and analyses of drug history, including pharmacoeconomics, product life cycle, detection of adverse events in clinical studies, and postmarketing risk assessment; regulatory guidelines, including issues of standardization of terminology (e.g., CDISC), tolerance and specification limits related to pharmaceutical practice, and novel methods of drug approval; and detection of adverse events in clinical and toxicological studies. Tutorial articles also are welcome. Articles should include demonstrable evidence of the usefulness of this methodology (presumably by means of an application).

The editorial board of SBR intends to ensure that the journal continually provides important, useful, and timely information. To accomplish this, the board strives to attract outstanding articles by seeing that each submission receives a careful, thorough, and prompt review.

Submitting Manuscripts

Submission of a manuscript for consideration is taken as representation that the manuscript has not been published previously and is not under review for publication elsewhere.

SBR is accepting submissions through an online system. Authors who wish to submit a manuscript should visit http://sbr.allentrack.net and follow the instructions for authors posted there. Questions regarding manuscript content should be addressed to Editor Joseph Heyse at joseph_heyse@merck.com. Questions regarding AllenTrack should be sent to Jina Lee, editorial coordinator, at sbr.asa@gmail.com.

Authors should submit the following files:

Upon final acceptance for publication, a LaTeX, Word, or other text file of the full text (without figures), along with individual files for all figures, will be required.

SBR uses a double-blind reviewing process. Referees are not informed of the name or institution of the authors of submitted manuscripts. Therefore, we request that two versions of the manuscript be supplied—a full version and another version with all marks that might identify the authors or their institutions removed; any identifiable sources of support should be removed along with obvious references to one’s own previous work.

The manuscript should be prepared using 8 ½ x 11-inch pages, double-spaced—including key words and references—with margins of at least one inch around all sides. Normal-sized fonts (e.g., 11 pt. or 12 pt.) should be used; the use of very small letters to save space is especially discouraged. Pages should be numbered consecutively. Authors are encouraged to use LaTeX if possible, and should use the “article” style, avoiding the use of any special macros. Use of BiBTeX is encouraged, but authors should submit the .bbl file. The manuscript should contain an abstract (see the abstracts paragraph) and from three to six key words or phrases (that do not appear in the title) in alphabetical order. For published manuscripts, these key words will be used—in addition to the title—for indexing in Current Index to Statistics.

Abstracts

Each manuscript should contain an abstract of about 200 words. The abstract is the most important part of any manuscript because it reaches large numbers of browsing readers. It is mandatory that authors pay great attention to the content and language of the abstract. The first part of the abstract should describe the manuscript’s motivation and contribution succinctly. For the benefit of SBR’s readership, the remainder of the abstract should amplify and illustrate, preferably using concrete examples and interesting special cases. Abstracts of accepted manuscripts will be posted to the SBR web site at www.amstat.org/publications/sbr.

General Comments on Style

Do not use footnotes, and avoid abbreviations. Represent exponentials by “exp( ).” Write fractions in text using a solidus—for example, (w + x)/(y + z). Do not use overbars extending over more than one character, or underbars. Use boldface for each symbol representing a vector or matrix. Avoid confusion between ambiguous characters (e.g., between lowercase “el” and one or zero and uppercase “oh”). Specific comments about mathematical material are provided in the ASA’s style guide, available from the SBR web site at www.amstat.org/publications/sbr.

Length of Manuscripts

There is no maximum length for manuscripts, but it is much more difficult and time-consuming to get reviews for long manuscripts. An efficient writing style with selective use of tables and figures is appreciated. Manuscripts accepted for publication rarely have more than 25 double-spaced pages, including text, figures, tables, and references.

Figures and Tables

Authors should provide extensive legends for their figures and tables to facilitate browsing and decoding of their content. Figures and tables should be numbered consecutively at the top of the page with Arabic numerals and should be titled and labeled clearly. Once a manuscript is accepted for publication, the authors should submit electronic versions of all figures. Figures may be in .ps, .eps, .tif, .gif, or .jpg formats. Please contact Production Editor Eric Sampson at esampson4@comcast.net with questions regarding figure preparation or format.

Data

Whenever a dataset is used, its source should be documented fully. When it is not practical to include the whole of a dataset in the manuscript, the manuscript should state how the complete dataset can be obtained. Authors are encouraged to submit such datasets for posting to the SBR web site (www.amstat.org/publications/sbr). Exceptions for reasons of security or confidentiality may be granted by the editor.

Appendixes

Lengthy technical portions of a manuscript should appear in a separate appendix to the manuscript.

References

References are to be cited in text with the authors’ names and dates of publication. We discourage the use of inessential unpublished or obscure references. Personal communications are listed in the text only. Do not abbreviate journal titles. Other details for listing and citing references are given in the ASA’s style guide.

Page Charges

To help defray the rising costs of publication, manuscripts published in SBR are subject to a voluntary page charge of $55 per printed page, to be billed to the institution or granting agency supporting the research. This charge represents only a portion of the cost per page. If the charge is honored, 100 free offprints will be supplied.

Copyright

SBR is copyrighted, and authors must sign a copyright transfer before publication. U.S. government employees are exempt from this requirement if the work is part of their official duties.

Submitting Revised Manuscripts

Revised manuscripts resubmitted more than six months after the last action by the editor may be considered new submissions.