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Clinical trials have a home in Blood

Jorge Cortes, Nancy Berliner and Bob Löwenberg

“Does Blood accept manuscripts reporting on clinical trials?” “Can I publish a phase 1 study in Blood?” These are some of the common questions we hear from our hematologist colleagues when they are trying to decide where to submit their best clinical work for publication. Blood, as an international journal with a truly global reach, publishing papers coming from over 100 countries each year, is proud to serve the interests of all members of the hematology community, whether clinical, translational, or basic. Clinical trials are critical in furthering our understanding of hematologic diseases and improving the care of patients. The results emerging from clinical trials are essential to the hematology scientific and practicing community as they provide a connection between our understanding of the biology of a given disorder and the translation of that understanding into improvements in clinical care. The results of such clinical trials not only can provide critical information for the management of patients, but also further inform our knowledge and raise questions to be addressed in the laboratory to continue our quest for further knowledge and better outcomes in patient care.

In a given issue of Blood there might be several manuscripts reporting results of clinical trials side by side with reports on basic hematologic and translational hematologic science. This variety is the result of our commitment to serve the whole of hematology and the hematology community in the widest sense as well as the science around it. The coverage of studies on clinical effectiveness in a journal like Blood makes more sense than ever because there is an intimate relationship between preclinical biological, genomic, and technological science and clinical research. In fact, an unprecedented amount of preclinical research is currently leading the way to clinical evaluation and application and these results often herald a prelude to new diagnostic and therapeutic strategies. Considering the weekly frequency of our publication, the number of clinical trials published in Blood is hefty and growing.

The Editorial team has made a strong commitment to attract and publish the best and most impactful clinical trial manuscripts in hematology. This means we welcome reports across the full spectrum of clinical trials and from all countries of origin, from first-in-humans, phase 1 trials, to reports of phase 4 studies. We believe the most important manuscripts reporting results of clinical trials in hematology belong in Blood and we are committed to make Blood their home. To do this, it is important for our readership to define what makes a clinical manuscript competitive for publication in Blood.

First, what is considered a clinical trial? We follow the World Health Organization definition which 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 effect on health outcomes.”1 We also adhere to the guidelines issued by the International Committee of Medical Journal Editors (ICMJE) requiring that trials must be registered in one of the ICMJE-approved public registries at or before the onset of patient enrollment. Information on these registries can be found at www.ICMJE.org and in the Blood Author Guide at http://bloodjournal.hematologylibrary.org/site/authors/authorguide.xhtml#clinical.

Phase 1 studies are critical to the development of new knowledge and are thus welcome in Blood. Phase 1 studies are competitive for publication when they describe, for example, a first-in-class molecule providing important mechanistic information that emerges from the study and is presented in the manuscript, when they describe high levels of clinical activity with a novel agent or a novel combination, or where groundbreaking information on the biology of the disease being studied is generated, potentially leading to the development of new biomarkers or contributing to the understanding of the mechanism of action of a new drug. A phase 1 study that solely describes the dose-limiting toxicity and maximum tolerated dose of a new drug or a combination of drugs will be less competitive for publication in Blood. In all instances, the study must be completed and meet the objectives set forth in the original trial design.

Well-designed and -powered phase 2 studies that answer important clinical or biological questions also have a home in Blood. Interim analyses may be considered when they constitute part of the original design, provided that the results merit publication. This includes studies demonstrating high levels of clinical activity or new safety information where dissemination of the information becomes important for the benefit of patient care. New and important biological information that emerges from such studies also merits publication in Blood.

Phase 3 studies, particularly definitive and pivotal trials, are an important focus of our publication strategy. Results of interim analyses can be considered if properly justified. Furthermore, interesting and important phase 4 studies and survivorship investigations may also be appropriate if they provide important new information.

Our goal is to make the best science in hematology welcome in Blood, whether it is clinical or basic, and in all disciplines covered by our ever-more-fascinating field. Every year we see the greatest clinical trials reaching their completion and it is only natural that those same studies, when ready for publication, find a home in Blood. Publishing in Blood is competitive because we continually strive to improve the Journal’s quality and offer a review and publication process that is rigorous and unbiased. It is our commitment to be fast and bring out important novel information with direct clinical relevance as soon as possible. For clinical studies that make a point of care we offer the option of a fast-track review procedure. And the Editors also ensure immediate access to the best clinical papers by removing the embargo barrier and publishing online, so that clinical hematologists, researchers, and patients can access this information with minimal delay.

Excellence will always find a place in our pages. As investigators we should consider Blood our first choice for the most relevant and impactful clinical trials so that, as readers, we continue to find Blood the most valuable journal for all aspects of hematology.

Footnotes

  • Submitted May 20, 2014.
  • Accepted May 20, 2014.

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