Concise Epidemiologic Principles and Concepts: Guidelines for Clinicians and Biomedical Researchers


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The Future of the Public's Health in the 21st Century.

Be sparing with abbreviations: only abbreviations firmly established in the field may be eligible. These keywords will be used for indexing purposes. Abbreviations Well-known abbreviations e. Units of measurement should be used in accordance with current custom and acceptability. Generic names of drugs are preferred; a proprietary name may be used if its generic equivalent is identified. Formatting of funding sources List funding sources in this standard way to facilitate compliance to funder's requirements:. It is not necessary to include detailed descriptions on the program or type of grants and awards.

When funding is from a block grant or other resources available to a university, college, or other research institution, submit the name of the institute or organization that provided the funding. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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Correct Use of Statistical Methods The correct use of statistical methods is paramount for a proper interrogation and interpretation of study data. There are several checklists available that can be used to help authors. The list covers general statistical problems, filtering, missing data, multiple comparison problems, multivariate modeling issues, use of imprecise language, graphics, tables, and other areas. Footnotes Footnotes should be used sparingly. Number them consecutively throughout the article. Many word processors build footnotes into the text, and this feature may be used. Should this not be the case, indicate the position of footnotes in the text and present the footnotes themselves separately at the end of the article.

Illustrations include charts, drawings, graphs, and photographs. Charts, drawings and graphs must be computer-generated and should use a Sans-serif typeface e.

Author Guidelines

Number figures consecutively in the order they are to appear in the text e. Figures should be uploaded as separate files, not embedded in the manuscript file.

Figure resolution for pixel-based images should be at least 1, dpi for line art e. Color images should use CMYK color mode. If any table or figure has been published previously, a copy of the letter of permission from the copyright holder must accompany the manuscript. The original source of the table or figure should be acknowledged in full reference form in the reference section of the manuscript.

Authors are responsible for applying for permission for both print and electronic rights for all borrowed materials, and they are responsible for paying any fees related to the application of these permissions. If, together with your accepted article, you submit usable color figures then Elsevier will ensure, at no additional charge, that these figures will appear in color online e.

For color reproduction in print, you will receive information regarding the costs from Elsevier after receipt of your accepted article. Please indicate your preference for color: in print or online only. Further information on the preparation of electronic artwork. Figure captions Ensure that each illustration has a caption.

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A caption should comprise a brief title not on the figure itself and a description of the illustration. Keep text in the illustrations themselves to a minimum but explain all symbols and abbreviations used. Tables Please refer to Maarten Boers' guidance on proper formatting and principles for effective tables.

Concise Epidemiologic Principles and Concepts: Guidelines for Clinicians and Biomedical Researchers

Figures and Tables accompanying manuscripts should not exceed a total of 6 and should be numbered and provided with suitable legends, in a separate electronic file. Do not insert vertical lines in tables. Include a title for each table. Number tables consecutively within the manuscript Table 1, Table 2, Table 3, etc. Authors should place footnotes in order, reading from left to right and top to bottom, and should begin a new series of footnotes for each table. Footnotes should not appear in table titles. Lengthy tables should be avoided as they might be too large to be reproduced in print.

However, they may be submitted as a web-only appendix. Citation in text Please ensure that every reference cited in the text is also present in the reference list and vice versa. Any references cited in the abstract must be given in full. Unpublished results and personal communications are not recommended in the reference list, but may be mentioned in the text.


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If these references are included in the reference list they should follow the standard reference style of the journal and should include a substitution of the publication date with either 'Unpublished results' or 'Personal communication'. Citation of a reference as 'in press' implies that the item has been accepted for publication.

A DOI is guaranteed never to change, so you can use it as a permanent link to any electronic article. Aseismic continuation of the Lesser Antilles slab beneath northeastern Venezuela. Please note the format of such citations should be in the same style as all other references in the paper. Data references This journal encourages you to cite underlying or relevant datasets in your manuscript by citing them in your text and including a data reference in your Reference List. Data references should include the following elements: author name s , dataset title, data repository, version where available , year, and global persistent identifier.

Add [dataset] immediately before the reference so we can properly identify it as a data reference. The [dataset] identifier will not appear in your published article. Reference formatting There are no strict requirements on reference formatting at submission. If you do wish to format the references yourself they should be arranged according to the following examples:.

Epidemiology and Biostatistics - An Introduction to Clinical Research | Bryan Kestenbaum | Springer

Journal abbreviations source Journal names should be abbreviated according to the List of Title Word Abbreviations. Data visualization Include interactive data visualizations in your publication and let your readers interact and engage more closely with your research. Follow the instructions here to find out about available data visualization options and how to include them with your article.

Research data This journal encourages and enables you to share data that supports your research publication where appropriate, and enables you to interlink the data with your published articles. Research data refers to the results of observations or experimentation that validate research findings. To facilitate reproducibility and data reuse, this journal also encourages you to share your software, code, models, algorithms, protocols, methods and other useful materials related to the project.

In response to specific cases in which unfavorable data from pharmaceutical company-sponsored research were not published, the Pharmaceutical Research and Manufacturers of America published new guidelines urging companies to report all findings and limit the financial involvement in drug companies by researchers. Drug researchers not directly employed by pharmaceutical companies often seek grants from manufacturers, and manufacturers often look to academic researchers to conduct studies within networks of universities and their hospitals, e.

Similarly, competition for tenured academic positions, government grants and prestige create conflicts of interest among academic scientists. In the United States, all clinical trials submitted to the FDA as part of a drug approval process are independently assessed by clinical experts within the Food and Drug Administration, [63] including inspections of primary data collection at selected clinical trial sites.

In , the editors of 12 major journals issued a joint editorial, published in each journal, on the control over clinical trials exerted by sponsors, particularly targeting the use of contracts which allow sponsors to review the studies prior to publication and withhold publication. They strengthened editorial restrictions to counter the effect. Researchers may be restricted from contributing to the trial design, accessing the raw data, and interpreting the results.

Clinical trial

Responsibility for the safety of the subjects in a clinical trial is shared between the sponsor, the local site investigators if different from the sponsor , the various IRBs that supervise the study, and in some cases, if the study involves a marketable drug or device , the regulatory agency for the country where the drug or device will be sold.

For safety reasons, many clinical trials of drugs [66] are designed to exclude women of childbearing age, pregnant women, or women who become pregnant during the study. In some cases, the male partners of these women are also excluded or required to take birth control measures. Throughout the clinical trial, the sponsor is responsible for accurately informing the local site investigators of the true historical safety record of the drug, device or other medical treatments to be tested, and of any potential interactions of the study treatment s with already approved treatments.

This allows the local investigators to make an informed judgment on whether to participate in the study or not. The sponsor is also responsible for monitoring the results of the study as they come in from the various sites as the trial proceeds. In larger clinical trials, a sponsor will use the services of a data monitoring committee DMC, known in the US as a data safety monitoring board.

This independent group of clinicians and statisticians meets periodically to review the unblinded data the sponsor has received so far. The DMC has the power to recommend termination of the study based on their review, for example if the study treatment is causing more deaths than the standard treatment, or seems to be causing unexpected and study-related serious adverse events.

The sponsor is responsible for collecting adverse event reports from all site investigators in the study, and for informing all the investigators of the sponsor's judgment as to whether these adverse events were related or not related to the study treatment. The sponsor and the local site investigators are jointly responsible for writing a site-specific informed consent that accurately informs the potential subjects of the true risks and potential benefits of participating in the study, while at the same time presenting the material as briefly as possible and in ordinary language.

FDA regulations state that participating in clinical trials is voluntary, with the subject having the right not to participate or to end participation at any time. The ethical principle of primum non nocere "first, do no harm" guides the trial, and if an investigator believes the study treatment may be harming subjects in the study, the investigator can stop participating at any time.

On the other hand, investigators often have a financial interest in recruiting subjects, and could act unethically to obtain and maintain their participation. The local investigators are responsible for conducting the study according to the study protocol, and supervising the study staff throughout the duration of the study. In other words, they or their legally authorized representatives must give truly informed consent.


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Local investigators are responsible for reviewing all adverse event reports sent by the sponsor. These adverse event reports contain the opinion of both the investigator at the site where the adverse event occurred, and the sponsor, regarding the relationship of the adverse event to the study treatments. Local investigators also are responsible for making an independent judgment of these reports, and promptly informing the local IRB of all serious and study treatment-related adverse events.

When a local investigator is the sponsor, there may not be formal adverse event reports, but study staff at all locations are responsible for informing the coordinating investigator of anything unexpected. The local investigator is responsible for being truthful to the local IRB in all communications relating to the study. Approval by an Institutional Review Board IRB , or ethics board, is necessary before all but the most informal research can begin.

In commercial clinical trials, the study protocol is not approved by an IRB before the sponsor recruits sites to conduct the trial. However, the study protocol and procedures have been tailored to fit generic IRB submission requirements. In this case, and where there is no independent sponsor, each local site investigator submits the study protocol, the consent s , the data collection forms, and supporting documentation to the local IRB. Universities and most hospitals have in-house IRBs.


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  5. Concise Epidemiologic Principles and Concepts: Guidelines for Clinicians and Biomedical Researchers Concise Epidemiologic Principles and Concepts: Guidelines for Clinicians and Biomedical Researchers
    Concise Epidemiologic Principles and Concepts: Guidelines for Clinicians and Biomedical Researchers Concise Epidemiologic Principles and Concepts: Guidelines for Clinicians and Biomedical Researchers
    Concise Epidemiologic Principles and Concepts: Guidelines for Clinicians and Biomedical Researchers Concise Epidemiologic Principles and Concepts: Guidelines for Clinicians and Biomedical Researchers
    Concise Epidemiologic Principles and Concepts: Guidelines for Clinicians and Biomedical Researchers Concise Epidemiologic Principles and Concepts: Guidelines for Clinicians and Biomedical Researchers
    Concise Epidemiologic Principles and Concepts: Guidelines for Clinicians and Biomedical Researchers Concise Epidemiologic Principles and Concepts: Guidelines for Clinicians and Biomedical Researchers
    Concise Epidemiologic Principles and Concepts: Guidelines for Clinicians and Biomedical Researchers Concise Epidemiologic Principles and Concepts: Guidelines for Clinicians and Biomedical Researchers

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