First published December 3, 2012 - More info
With the December issue of the Journal of Clinical Investigation, I announce the launch of a new category of manuscript called “Clinical Medicine,” along with new editorial board members to adjudicate the peer-review process. With this initiative, the journal aims to publish the highest quality human research that reports early-stage, effective new therapies that impact disease outcomes.
Alfred Cohn, the first Editor in Chief of the Journal of Clinical Investigation, eloquently pointed out in his 1924 inaugural editorial that the goal of academic medicine is to pursue clinical investigations that promote, “a legitimate interest in learning as well as a means for furthering the methods which lead to the cure of disease (1).” Now, 10 months into my first year as Editor in Chief, I marvel at the wonderful mechanistic studies using sophisticated loss-of-function and gain-of-function in vivo experiments that are submitted to the journal. Equally, however, I am disappointed that the JCI is not a primary destination for clinically based investigations. The JCI was founded on the principle that clinical research will lead to better medical care, and research in humans has been its core value. While the pursuit of mechanistically based biology in medicine has necessitated studies using genetically tractable systems, the number of studies submitted to the journal that test a new therapy for a human disease is low.
Through the years, the JCI has strived to publish articles that elucidate the mechanisms of human disease, but our connection to disease therapy, one of the tenets of the JCI’s founders, has become less direct. Indeed, the logical extension of our mission at the journal is to publish original research in humans that describes a new therapy for a disease. After all, we are the Journal of Clinical Investigation. Few journals have the ability to publish in the same issue a detailed mechanistic study in a model organism next to human research that advances a new therapy for a disease. It is with this appreciation that I am introducing a new Clinical Medicine initiative at the JCI, for which we invite human research studies that test new therapies that have the potential to change the practice of medicine.
Clinical Medicine articles should report original research of new medical therapies or interventions in humans that are of interest to the general medical community and that have the potential to change the practice of medicine. I encourage the submission of manuscripts describing original research in humans of new concepts in therapy, such as first-in-class drugs and new interventions and procedures or diagnostic advances. I encourage the submission of reports of intervention trials, including phase I or II trials, which provide the first demonstration of efficacy for a new therapy as well as reports of rigorous observational studies and meta-analyses. Phase III clinical trials will be considered if they provide a definitive assessment of a therapy on disease outcomes. The JCI will not consider case reports in this Clinical Medicine category.
To provide the highest quality peer review for these articles, I have expanded our editorial board to include Clinical Medicine Associate Editors with expertise in human research within the multiple disciplines of medicine. Publishing excellent scientific research in humans requires an editorial board of the highest quality. The associate editors handling these manuscripts are all expert clinical researchers who are highly regarded in their respective disciplines. I am very fortunate to be surrounded by such talented and dedicated individuals.
Ethical conduct in research is a complex and evolving field that requires considerable attention during the publication of original human research. I am fortunate that Arthur Caplan, professor and head of the Division of Bioethics at New York University Langone Medical Center has agreed to be a member of the editorial board. His insights into bioethics and health policy will help guide us as new therapies and technologies are submitted to the journal that push the boundaries of medicine in society. From the policy perspective, protection of human subjects is an essential component of human research. I am delighted that Bruce Burnett, Director of Regulatory Affairs at the Duke Translational Medicine Institute, will join the editorial board as our regulatory affairs editor to ensure that submitted manuscripts adhere to best practices, as outlined in the International Ethical Guidelines for Biomedical Research Involving Human Subjects.
I am thrilled about the launch of this initiative at the journal and look forward to reading original clinical research studies that one day may change the way we practice medicine. As René Laennec, the French physician and inventor of the stethoscope once said, “The aim of medicine is the cure of disease” (1). I look forward to publishing your research in the JCI that reports on new therapies that will cure human disease.