On-line journal provides industry with open access
On-line journal provides industry with open access
Journal wants all results — positive and negative
A relative newcomer to the world of journal publishing is working on improving human subjects and other research through greater transparency and easier access to results — both the positive and the negative.
The Public Library of Science (PLoS) in Cambridge, United Kingdom, was established in 2000 primarily for the purpose of providing the public access to research papers.
The founders were concerned about the problem of access to scientific literature as a whole since most journals seven years ago were subscription based, says Emma Veitch, PhD, publications manager of PLoS Clinical Trials.
"You could only read them if you subscribed to the journal or were in a research institution that had a library," Veitch notes. "So the public could not see the results of research that was paid for with tax dollars."
The conventional process also slows down research, Veitch says.
"You can stimulate the process of scientific discovery by widening access to scientific materials, and with the Internet, you don't need to use a subscription," she adds.
While it costs money to review research and publish it, this can be covered by a one-time cost, Veitch says.
"The business model behind PLoS is having grants from foundations established for initial funding, and then there are charges for funders who sponsor research," she explains. "It's a one-time fee for studies that are good enough to be published in a PLoS journal."
The one-time fee is $1,250 to $2,500. For those who cannot find funds for the publication fee, then they can specify this when they submit their study, and if the study is accepted for publication the fee will be waived, Veitch says.
What's most unique about PLoS journals, including PLoS Clinical Trials, which was launched in May 2006, is that researchers agree to PLoS' copyright stipulations that anyone can access the content, reproduce it, use it in derivative publications, use it in slide shows, use it in teaching materials, or put it to any creative use, so long as they acknowledge the original citation and publication, Veitch says.
One of the goals of PLoS Clinical Trials is to encourage researchers to send in their unpublished results, particularly if the results are negative, Veitch notes.
"We're trying to motivate people by saying, editorially, that we will not be prejudiced against those studies," she says. "The methodological rigor and quality of reporting of the trial are the only things that matter in our editorial evaluation of the paper."
As long as the trial is done properly, the journal will make an effort to publish it, without concern about the results, she adds.
The reason for this approach is to address the problem of publication bias in trial literature," Veitch says. "As a lot of people are aware, you have the problem of negative results are less likely to be published."
Therefore, the evidence-based rule is skewed by what's publicly available, and these typically are positive results, Veitch says.
"You can get a mistaken estimate of efficacy and safety of drugs and other types of therapeutic interventions, and clearly that can have a damaging impact on patient care," Veitch says. "So we're trying to encourage reporting of negative results and encourage reporting outcomes of clinical trials."
The open access agenda of PLoS and the recent push for clinical trial registries have a natural link, Veitch notes.
"In my mind they fulfill a very distinct and not-overlapping function," Veitch says. "Registries provide the core dataset of each trial."
These include 20 or so data elements that tell the following:
- what condition is being studied;
- what the sample size is;
- how many people enrolled;
- who is running the trial;
- what the main outcomes are;
- what the drug intervention is, and;
- what the basic elements of the study are.
The purpose of registries is to promote transparency by allowing a trial to be tracked throughout the course of the design of the trial, including recruiting, patient enrollment, conducting the study, and closing the study, Veitch explains.
"You make sure you can track those results," she adds.
"At the moment, registries are not providing a way for presenting results from trials," Veitch adds. "What PLoS Clinical Trials does is provide a way to report the results effectively and show what is happening in the trial."
The online journal will provide links, when available, to the original registry so there is a connection between them, she says.
"I think in that way there is a very close link, and someone can go back and look at the original trial registry to see if outcomes were reported as originally stated," Veitch explains.
"Someone can say, 'This paper shows XYZ, but we can see from the registry the investigator planned to show this outcome that is not presented in the paper,'" Veitch says. "It helps you pinpoint possible selective bias or reporting."
PLoS has eight peer-reviewed, open access scientific and medical journals, including these:
- PLoS Biology;
- PLoS Medicine;
- PLoS Computational Biology;
- PLoS Genetics;
- PLoS Pathogens;
- PLoS Clinical Trials;
- PLoS ONE; and
- PLoS Neglected Tropical Diseases, which will be launched this year.
For PLoS Clinical Trials there are three peer reviewers, typically, including a statistician and an academic/clinician expert in the appropriate subject, Veitch says.
Peer reviewers, who are community members and are unpaid for their work in evaluating studies, normally are specialists in a particular study's field.
Peer reviewers assess whether the study was done properly, methodologically sound, properly reported, and whether all statistics and results were reported properly.
"These are the main things we're trying to bring out — a set of more detailed guidelines based on the Consolidated Requirements for Reporting Clinical Trials guidelines," Veitch explains. "We want readers to get the most out of what our findings are in a study and what it means in the larger context of what other research is available."
So far, PLoS Clinical Trials has published about 50 trials.
One recent published study involved the Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT), which was stopped early.
"Efficacy information isn't yet available, but safety data are available from the study, and this is important in contributing to the debates about safety of COX inhibitors," Veitch says.
"We're trying to say that we're very happy to publish results of studies that are stopped early," she adds.
"We're publishing across a broad range of specialty areas, but our main focus is to have enough information for everyone to get something out of the findings because it's published under open access," Veitch says. " PLoS is a very young organization, but the feedback we get is it has very quickly acquired a degree of respect amongst the scientific and clinical trials communities."
In the October, 2006, edition of PLoS Clinical Trials, author Elizabeth Wager wrote about why clinical trial results are published, including medical research motivations of improving clinical practice, informing patients, influencing future research, and preventing duplication of effort.
Other motivations are personal, including enhancing reputations and career prospects, and measuring a department's productivity, and financial, such as increasing a drug's sales.1
Wager's essay also offers examples of problems with reporting clinical trials and some possible solutions, including one solution that PLoS Clinical Trials has affected: posting results on accessible Web sites at minimal (or no) cost.1 (See table regarding reporting results, above.)
PLoS Clinical Trials focuses primarily on the results of randomized trials because these are the most carefully controlled studies, Veitch says.
"We only publish the most rigorous sorts of results," Veitch says. "We're looking at broadening our focus in the future, but we specifically look for randomized trial results from across all specialties."
PLoS ONE is a new concept at PLoS. It's an open access journal that aims to provide a place for publication of original research across all biology and medicine, and it's not restricted to any research area, Veitch says.
"We intend to break down the boundaries between disciplines," she says. "And what's new and special about PLoS ONE is that after peer review and the paper is published, the PLoS ONE platform provides a way for the scientific community to engage with the paper and have an open discussion post-publication on the accepted paper."
People can see on the Web site how to directly discuss the paper through a comment that's posted as an open comment on the article, and people can add their comments to the comments, as well, she explains.
"So it becomes a living object, as it were," Veitch says. "It's really moving to a more Wikipedia-like model for publication, but you obviously have the process of vetting very much like peer review."
The PLoS ONE content is similar to PLoS Clinical Trials, she notes
"It's focused on the methodological rigor of the study," Veitch says. "As long as it provides a novel advance in its field, and the study has been properly done and the methodological quality is good, it will be published."
PLoS ONE launched with 103 papers ranging from ecology to genetics to psychiatry.
Reference:
- Wager E. Publishing clinical trial results: The future beacons. PLoS Clinical Trials. October, 2006:e31:1-4. Web: www.plosclinicaltrials.org.
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