New journal will publish results from all scientifically sound clinical trials
Why publishing negative and “less impactful” results and methods is important for researchers and patients
By Paul-André Genest, PhD Posted on 26 June 2015
Clinical trials are a vital step in bringing new treatments and preventative medication to market because they test a drug’s safety and effectiveness. When the results of clinical trials are published, they can be informative to scholars, medical professionals, policy makers, the media and the public.
But not all trial results are conclusive or significant, and many trials show that drugs are ineffective. What happens to those results?
As part of the move to make clinical trial results more accessible, Elsevier is launching a new open access journal to provide an outlet for negative or less impactful trial results. Contemporary Clinical Trials Communications is a spin-off of the well-established journal Contemporary Clinical Trials, and it aims to tackle the problem of publication bias towards positive results by making all trial data open access.
“A major objective of the journal is to reduce publication bias, which is a major issue in the field of clinical trials,” said Dr. Zheng Su, co-Editor-in-Chief of Contemporary Clinical Trials Communications and VP at the Deerfield Institute in New York, a company that specializes in analyzing the efficacy of new medical technologies and services. He explained that through timely dissemination of advances in clinical trials, the journal can improve communication and collaboration within the global clinical trials community, ultimately benefiting patients.
Publishing trial results to help patients
Every journal has its own aims and scope, and that directs what gets published in the journal. In the case of Contemporary Clinical Trials, results of the trials with the biggest impact are published, which means many of the papers outlining less impactful results – or results that seem to be of little importance at the time – are not in the scope of the journal, even though they could be relevant to other researchers.
Since these results often don’t get published, either because they’re not suitable for a journal or because the researcher does not consider them worthy of publication, we can end up with a publication bias towards positive results. Thousands of clinical trials go unreported, which means that researchers cannot access the results or methodology of previous trials and often end up wasting time duplicating the tests only to reach the same conclusions. This is bad news for research, and for patients; time spent reinventing the wheel could otherwise have been spent on different approaches.
Funding bodies and clinical trial sponsors are already asking trialists to make methodology and results available to everyone. By launching the new spin-off title, we can give those papers a home, providing researchers the information they need to carry out effective, useful trials rather than duplicating efforts.
“There are several existing clinical trials journals that either give preferential treatment to positive trial results due to their perceived higher significance, or focus only on randomized trials,” said Dr. Zhezhen Jin, co-Editor-in-Chief of Contemporary Clinical Trials Communications and Associate Professor of Biostatistics at Columbia University in New York. “In contrast, Contemporary Clinical Trials Communications provides a platform for trialists around the world to share their knowledge on all aspects of clinical trials. We’re making scientifically valid and technically sound original research findings freely accessible regardless of their perceived importance or impact.”
Sharing methodology for different kinds of clinical trials
There are two main approaches to clinical trials: randomized and non-randomized. In randomized trials, there are two groups – treatment and control – and the participants do not know whether they are receiving the treatment or a placebo/control. In non-randomized trials, the participants are often all given the treatment; this is a common approach for testing treatments of rare diseases. Many clinical trials journals only publish randomized trials, but Contemporary Clinical Trials Communications will publish both.
Within these two approaches, there are many ways to carry out a trial. How many patients were enrolled and how were the cohorts randomized? What treatment was given and how frequently? Contemporary Clinical Trials Communications will publish clinical trial statistics and methodology that answers questions like these, enabling researchers to build on each other’s work and design trials more efficiently and effectively.
Clinical trials are complex research projects involving many people. Biostatisticians, clinicians, doctors and program managers work together to run the trials, monitor progress, record results and analyze findings. To make sure the journal meets the needs of the community, the international editorial board comprises renowned experts at top academic institutions and professionals at respected pharmaceutical companies.
“I trust that the readers will find the journal a valuable source of recent advancements in clinical trials,” said Dr. Jin, adding that the knowledge can “facilitate the design, conduct and analysis of their trials.”
Building on an established brand
Ten years ago, Controlled Clinical Trials changed its name to Contemporary Clinical Trials and refined its scope, aiming to publish significant clinical trials results. The journal has continued to grow, and with more submissions, we are rejecting more papers. A lot of these papers are of importance to the clinical trials community; although the results may be negative, it’s vital that the community knows about them.
A decade after the re-launch, we’re now adding to the brand with the new open access spin-off Contemporary Clinical Trials Communications. The journal will publish:
- Scientifically sound results
- Positive and negative results
- Articles transferred from Contemporary Clinical Trials, and direct submissions
- Statistics and methodology papers
The cover of the journal represents the four phases of clinical trials, capturing what the journal is about: making clinical trials – including their design and results – more accessible.
Contemporary Clinical Trials Communications is now accepting submissions: we welcome all scientifically sound clinical trial results and methods, and hope the journal provides the community with a much-needed resource, helping trialists make the most of their research.
Dr. Zhezhen Jin isAssociate Professor of Biostatistics at Columbia University in New York, withmore than 100 publications in the field of clinical trials research. Dr. Jin isan elected fellow of the American Statistical Association, the Executive Directorof the International Chinese Statistical Association (ICSA) for 2014-2016, andserves on the editorial boards of the journals Contemporary Clinical Trials, Lifetime Data Analysis, Kidney International and Communications for Statistical Applicationsand Methods.
Dr. Zheng Su is the Vice Presidentof the Deerfield Institute, where he leads the research effort on clinicaltrial methodologies. Previously, he was involved in the design, conduct andanalysis of a number of clinical trials at Genentech. He has been a facultymember at the State University of New York, Stony Brook, and a visitingfaculty member at Stanford University. Dr. Su has published more than 50peer-reviewed articles on clinical trial methodologies. He serves on the editorialboard of several journals and has been the Editor-in-Chief of Contemporary Clinical Trials since 2012.
Elsevier Connect Contributor
Dr. Paul-André Genest is an Associate Publisher at Elsevier, responsible for a portfolio of journals in Life Sciences. Previously, he was Managing Editor of the International Journal for Parasitology: Drugs and Drug Resistance (IJP:DDR), the International Journal for Parasitology: Parasites and Wildlife (IJP:PAW) and the Malaria Nexus web portal. Dr. Genest has a BSc (Biology) degree and a MSc (Microbiology-Immunology) degree from the Université Laval in Québec City, Canada, and a PhD (Molecular Parasitology) from the University of Amsterdam, the Netherlands. He held two postdoc research positions at the NetherlandsCancer Institute before joining Elsevier in 2012.