Biomarker Evaluation and Clinical Development
Abstract
Most candidate biomarkers are never adopted into clinical practice. The likelihood that a biomarker with good predictive properties will be incorporated into urologic decision-making and will improve patient care can be enhanced by following established principles of biomarker development. Studies should follow the REMARK guidelines, should have clinically relevant outcomes, and should evaluate the biomarker on the same patients to whom the biomarker would be applied in practice. It is also important to recognize that biomarker research is comparative: the question is not whether a biomarker provides information, but whether it provides better information than is already available. Continuous biomarkers should not be categorized above or below a fixed cutpoint: risk prediction allows for individualization of care. The risk predictions must be calibrated, that is, close to a patient’s true risk, and decision analysis is required to determine whether using the biomarker in clinical practice would change decisions and improve outcomes. Finally, impact studies are needed to evaluate how use of the biomarker in the real world affects outcomes.
The Société International d'Urologie (SIU), which owns and publishes the Société International d'Urologie Journal (SIUJ), does not require authors of papers published in the journal to transfer copyright. Instead, we ask authors to grant an exclusive licence that allows us to publish the article in SIUJ (and any derivative or related products or publications) and that allows us to sub-license such rights and exploit all subsidiary rights.
Authors retain the right to use their own articles for their own non-commercial purposes without seeking explicit permission from SIU.
The SIUJ publication licence expressly defines “non-commercial” as “not primarily intended for or directed towards commercial advantage or monetary compensation.” Although no activity is completely disconnected from commercial activity, the following are generally considered to be non-commercial uses:
- Reproduction of a reasonable number (no more than 100) of print copies of the published paper for personal use (e.g., sharing with colleagues, including in grant applications).
- Posting a copy of the published version of the paper on the author’s own or their institution’s website. The article must be accompanied by this statement: ‘This article has been published in the SIUJ: [full citation; link]’.
- Inclusion of the paper in a course pack, with a maximum of 100 copies to be used in the author’s institution. The copies must include the following acknowledgement: ‘This article has been published in the SIUJ: [full citation; link].’
As the distinction between commercial and non-commercial is not always clear, authors are strongly advised to seek permission from SIU for any use that may be considered to have a commercial aspect.
We ask the corresponding author to read the terms of the licence and then to grant this exclusive licence on behalf of all authors by indicating agreement to the following statement:
The corresponding author has the right to grant on behalf of all authors and does grant on behalf of all authors, an exclusive licence on a worldwide basis to the SIU and its licensees to permit this article (if accepted) to be published in the SIUJ and any other SIU products and publications and to exploit all subsidiary rights, as set out in our licence agreement.
Review and Decision
Most submissions will be reviewed by a senior editor within 2 weeks. Many manuscripts will be rejected at this point for a variety of reasons, including subject matter outside the scope of the SIUJ, flawed design, discredited or outdated methodology, poor organization or presentation, failure to conform to ethical requirements, and apparent plagiarism.The remaining manuscripts will be sent for peer review. The SIUJ uses a single-blind process: reviewers know the identity of the authors, but the authors are not told who has reviewed their manuscript, and SIUJ ensures that potentially identifying information is removed from comments sent to them. Reviewers are asked to make their recommendations within 10 days, after which a senior/specialist editor will consider their comments and recommend provisional acceptance dependent on satisfactory revision, acceptance without revision, or rejection. Authors should receive a final decision within 4 to 6 weeks of submission.
