In 2008, Jeffrey Beall, an academic librarian, noticed that he was receiving spam email solicitations from broad-scoped, newly formed open access (OA) journals whose main intent seemed to be the collection of article processing/publication charges. He later coined the term “predatory” to describe these journals and publishers with dubious practices. Since then other terms have been used, such as “questionable,” “deceptive,” and “pseudo.” However, regardless of what term is used, the practices of these journals and publishers are strikingly similar. (See graphic)
Predatory publishers are a threat to scientific integrity as they make it difficult to demarcate sound science from fake science that can be damaging to public health.
In 2016 the Federal Trade Commission (FTC) issued a complaint against OMICS, a publisher of hundreds of online journals, accusing them of deceptive practices including publishing articles with little to no peer-review and listing prominent academics as editorial board members without their consent. Then, in 2017, an article published in Bloomberg Businessweek reported that several prominent pharmaceutical companies, including AstraZeneca, Bristol-Myers Squibb, Gilead, Merck, Novartis, Eli Lilly, GlaxoSmithKline, and Pfizer, had published in OMICS journals or participated in OMICS congresses. The article questioned “whether drugmakers are purposely ignoring what they know of OMICS’s reputation or are genuinely confused amid the profusion of noncredible journals.”
This article brought the problem of predatory journals and publishers to the forefront at Pfizer and increased our awareness of this growing problem. Since then we have taken steps to address this issue by increasing colleagues’ awareness of predatory journals, publishers, and congresses, and making changes to our publications software application such that it is easier to identify OMICS journals before they are imported into the system. We are also researching subscription-based tools such as the Journals & Congresses database, which has stringent criteria for inclusion.
But what else can be done to reduce the amount of research published by predatory journals, not only by pharmaceutical companies but by all parties involved in the development of medical/scientific publications? (See graphic)
Some organizations have already taken action. In 2014, the Directory of Open Access Journals (DOAJ) developed more stringent criteria for indexing and required journals to reapply for inclusion and, in November 2017, the National Institutes of Health (NIH) issued a statement requesting that NIH-funded research be submitted to reputable journals to help protect the credibility of papers arising from its research investment.
Please note that the content of this blog post was prepared by me, Angela Sykes, in my personal capacity. The opinions expressed in this presentation are my own and do not reflect the views of Pfizer.
Most of us are aware of “predatory” journals and congresses that promote themselves as legitimate but practice deceptive or exploitative practices at the expense of unsuspecting authors. Many fail to deliver even the basic editorial or publishing services provided by reputable journals or the networking value provided by legitimate congresses. Beyond the implications for authors in terms of cost, credibility, and reputation of being associated with these predatory journals/congresses, they also rob the scientific community of timely access to research. So what steps can we take to protect ourselves from their predatory practices?
To provide you with a framework for making your own assessments, below are 8 criteria I use to evaluate the probable legitimacy of journals or congresses based on their websites. Try not to put too much emphasis on a single item, but if a journal/congress website falls short on more than one, you may be dealing with a predator.
Less is more! Legitimate journal/congress websites typically have a “clean” look. Conversely, predators often have a “busy” look and inconsistent font choices, poor text and photo alignment, bad line breaks, and a plethora of animations. In short, they look amateurish. Scrolling text banners at the top of the page are especially suspicious. Beware if contact information uses free email providers such as Hotmail or Gmail.
Although small international journals/congresses can be perfectly legitimate and still have a few English-as-a-second-language grammar and usage errors, a large number of typos and grammatical errors is a clear red flag. Also, look for sections that are riddled with errors alternating with error-free sections; this may be a clue that some content was plagiarized.
Designers of many predatory websites seem unable to reduce photo sizes proportionally, leading to “squashed” images. Also, be suspicious of a small journal/congress with a large number of alleged editorial board or faculty members, or “rock star” names in the field. These people probably are unaware they are on the website, and their photos may have been captured from LinkedIn, Facebook, etc. Finally, are photos from a past meeting cropped tightly, in such a way that you can’t tell if there were 20 attendees or 200?
Logos of sponsoring or partnering organizations should be functional hyperlinks. Predatory websites often present a dizzying collage of nonfunctional logo images, some wildly inappropriate for the subject matter of the journal/congress.
Look out for that little construction worker! Legitimate websites should have complete content. For example, a journal editorial board that is “Coming Soon” or an impending congress with venue information still “Under Construction” is likely a predator. Additionally, journals or congresses with an extremely broad focus, perhaps combining medical and physical sciences, are likely predators.
Can you make your own travel arrangements if you prefer? Required use of preferred travel and accommodations vendors is a red flag for congresses. Such companies are usually owned by the sponsoring organization. Look for clear statements of all registration costs and refund policies. Look for a secure mechanism for credit/debit card payments (lock icon in the URL), and avoid sites that merely provide bank transfer information.
A very devious tactic predatory journals and congresses often use is to craft a name very similar to that of a legitimate counterpart, or to “clone” the content of a legitimate website, or to associate their predatory journal with a legitimate one on the same site. Often they just add a word, such as “American” or “International,” to a legitimate journal/congress name. Unmasking these frauds can be very challenging.
Predators will often spoof a location in the United States or Europe, but there are web tools that can trace the true location of the web domain housing a website. You can also use Google Earth to check the street address and make sure it is not simply a house or a storefront. Be cautious if the address given is in Delaware, as incorporation laws make it easy for an overseas predator to register a business there.
Finally, network with your senior colleagues. Has anyone ever heard of this journal or congress? Have they published in the journal or attended a meeting? Were their experiences positive?
A little due diligence upfront will pay off in the long run to ensure you get the most from your publication and congress experiences. Although the tips I’ve provided here may give you some objective evidence regarding the legitimacy of a journal/meeting, your instincts are also valuable. If it feels wrong, it probably is.
Clinical research needs volunteers to participate in studies—they participate, providing informed consent, with an understanding that the information and data generated will help further scientific knowledge and medical science, ultimately benefiting patients.
Without public disclosure of the findings in journals, at congresses, and on internet-based registers, this fundamental scientific benefit is limited. We and others have developed policies and processes to make results from our clinical trials publicly available. But is this sufficient? Journal articles provide aggregate data; they do not provide other researchers with access to the underlying patient-level data so that these data can be interrogated and used to help answer other research questions.
A number of platforms have emerged over the last 5 years through which researchers can access anonymized patient-level data. We use the Clinical Study Data Request site (www.clinicalstudydatarequest.com ), which is also used by 12 other sponsors and lists more than 3,500 studies as available for data sharing.
Researchers are provided with remote access to anonymized patient-level data in a secure access system where statistical software is provided and researchers can download results of their analyses. This system protects the data from inadvertent public disclosure and prevents use of the data for a purpose that has not been scientifically and independently reviewed or approved.
However, the secure access system is costly and can be cumbersome for researchers; there can be difficulties where researchers wish to use other statistical software or combine the data we provide with other data available outside the system or in another system. What are the alternatives?
Security of the data is a must. However, data security in terms of a secure IT system does not necessarily need to be provided by the study sponsor or data provider. Therefore, where researchers provide assurances that the data will be stored and used in a secure IT environment with data governance controls, GSK now provides encrypted data directly to researchers. We believe this approach facilitates the use of the data for science with controls to protect the data from misuse and inadvertent disclosure.
As more and more data-sharing platforms emerge, if the research community is to fully realize the scientific and patient benefits of data sharing and meet the expectations of volunteers who participate in studies, we need to move away from reliance on remote, centrally provided data access systems.
New York University School of Medicine
As the founder of the nonprofit Bioethics International and the Good Pharma Scorecard , I have been working on developing standards for clinical trial transparency and benchmarking the performance of new drugs and drug companies against those standards. Our goal is to improve ethics, trustworthiness, and patient-centricity/engagement in the development and commercialization of medical products and healthcare innovation. Our initial area of focus is clinical trial transparency.
At BEI, transparency means that trials are registered, have summary results accurately reported in a public databank, are submitted for publication in the medical literature, and comply with US disclosure requirements defined in the Food and Drug Administration Amendments Act of 2007 (FDAAA). We also support the sharing of patient-level data and the returning of lay summary results to trial participants.
In the Good Pharma Scorecard, we assess transparency for 3 different groups of trials: all trials in an FDA-approved New Drug Application (NDA), patient trials (trials conducted in patients, excluding trials in healthy volunteers), and FDAAA-applicable trials (trials legally required to be reported in ClinicalTrials.gov).1
We benchmark transparency using these 3 different sets of trials, because we found that clinical trial transparency means different things to different people, groups, and institutions. Thus, we try to provide key stakeholders with the performance metrics that are meaningful and useful to them.
We regularly convene stakeholders such as patient groups, physician groups, ethicists, academics, and companies to understand what clinical trial transparency and ethical innovation means to them. In turn, we help catalyze stronger consensus and operationalization of best practices. We also try to connect with regulators and other groups to develop guidance and opportunities to align our work with theirs.
As part of this work, my team at BEI reviewed the data sharing statement from the International Committee of Medical Journal Editors (ICMJE), which advises researchers to publicize their data-sharing policy each time they publish clinical trial results in one of their member journals. We applaud this step forward, but the ICMJE was largely silent on the contents of those policies. Technically, an author could have a policy that states they won’t share any data.
To avoid this, BEI proposes researchers and trial sponsors commit to sharing analyzable datasets and Clinical Study Reports (CSRs) for all phase 2 and 3 trials by the latter of 6 months after regulatory approval of a new drug or 18 months after the trial’s completion. These proposed timelines are similar to those of the Institute of Medicine (IOM)-National Academy of Medicine (NAM).
Better transparency definitions and implementation are pillars for trustworthiness in healthcare innovation, but it’s also important to note that increasing levels of transparency have opened up other ethics conversations. For example, thanks to enhanced transparency we now know more details about clinical trial designs and enrollments. Stakeholders have noticed that drugs are often tested on younger, whiter, and healthier populations than the patients who ultimately will use a drug after FDA approval.2 Typical patients are often older, sicker, and more ethnically diverse than trial participants. As a result, stakeholders now want to improve trial designs, improve inclusivity in trial enrollment, and use more real-world evidence in drug development.
So, it is tempting to worry that the spouting whale will get harpooned, meaning if we disclose more information, it will expose all of us to more complaints and criticism.
However, criticism isn’t all negative; it actually represents hope. The fact that people are complaining about problems means they recognize that things can be better and the importance of the work being done in drug development. I am confident that BEI and other groups can work together to define what best practices look like and what metrics can be used to track progress over time. After all, what gets measured often gets done. And, implementation and recognition of best practices will be a cause for celebration—no harpoons needed.
When it comes to accessing clinical trial data, for me “transparency” means above all clarity and openness, a willingness and indeed a desire to share data from clinical trials.
I speak as chairperson of the Steering Committee of ClinicalStudyDataRequest.com (CSDR) , which is a group of 13 major pharmaceutical companies dedicated to facilitating greater access to clinical trial data to promote scientific research. As such, I applaud ICMJE’s efforts in support of data sharing.
CSDR has been a leader in the broader movement by pharmaceutical companies and other institutions that fund trials who are together transforming the data disclosure landscape. CSDR offers access to detailed information from clinical trials in ways unheard of just 5 years ago.
By being transparent and inviting researchers to access clinical trial data, CSDR hopes to foster research by giving scientists access to a rich set of data. The fruits from this research, once published, are intended to advance patient care, contributing to medical knowledge more generally.
CSDR currently lists more than 3,400 clinical trials and this list is expanding quickly—often as a result of enquiries from researchers. Researchers are encouraged to submit requests for the detailed, anonymized, patient-level data from these trials. They can request access to trials across multiple sponsors, and access is free. Each request is reviewed independently by a process overseen by the Wellcome Trust. On approval and receipt of a signed data-sharing agreement, the data are made available in a secure environment—one that facilitates the research while at the same time preserving the privacy of patients who were part of the trials.
The available clinical trials span a wide range of disease areas. Today there are more than 360 diabetes and 240 asthma trials, for example. So far there have been 335 requests from researchers for trial data. A publication plan is required so that results can be shared broadly. Some results may be published in journals associated with the ICMJE or in other journals that may encourage sharing of patient-level data. Those data may in turn be shared on CSDR—a cycle of knowledge that, in the end, will help inform the scientific community and ultimately benefit patients.
Executive Deputy Editor, Annals of Internal Medicine
Secretary, International Committee of Medical Journal Editors
The International Committee of Medical Journal Editors (ICMJE) recently announced a requirement for data sharing statements as a condition for consideration at our member journals of manuscripts describing the results of clinical trials, effective July 1, 2018. In addition, clinical trials that begin enrolling participants on or after January 1, 2019, must include a data sharing plan in the trial’s registration.
By adopting these criteria, ICMJE aims to help fulfill our ethical obligation to trial participants who put themselves at risk on the promise that we will make the most of the information gathered in order to improve clinical care. Although sufficient infrastructure is not yet in place for the ICMJE to mandate data sharing at this time, requiring data sharing statements reflects our commitment to help move the scientific community toward creating the environment in which sharing is expected. ICMJE is excited to engage multiple stakeholders such as Medical Publishing Insights & Practices (MPIP) and the International Society for Medical Publication Professionals (ISMPP) in this endeavor.
MPIP has inquired about the content of data sharing statements that would meet the ICMJE requirements. Data sharing statements must indicate the following items: whether individual deidentified participant data (including data dictionaries) will be shared; what data in particular will be shared; whether additional, related documents will be available (eg, study protocol, statistical analysis plan); when the data will become available and for how long; by what access criteria data will be shared (including with whom, for what types of analyses, and by what mechanism). Illustrative examples of data sharing statements (including example mechanisms by which data will be made available) that would meet these requirements are in the Table of the editorial announcing these requirements at http://www.icmje.org/news-and-editorials/data_sharing_june_2017.pdf .
It is important to note that the examples provided represent some, but not all, possible statements that would fulfill the ICMJE requirement. These may range from unrestricted, publicly available access to deidentified data without restrictions, to a statement indicating that data will not be shared. The important thing is to be transparent about what will be done regarding each of the items noted above.
MPIP also asked how journal editors will evaluate data sharing statements, and how the information provided will be factored into editorial decisions. All ICMJE editors will check to be sure that the data sharing statements include the items outlined above and in our editorial. Although all data sharing statements must address these items, editors may differ in the data sharing plans they find acceptable. Some ICMJE editors already require that data will be shared, as indicated in their information for authors. Others do not currently have such a rule (although they may adopt it in the future) and the degree to which a more or less restrictive data sharing statement will influence editorial priorities may vary. As a general rule, all of the editors would have a preference for plans indicating that data will be responsibly shared. Peer reviewers will see the data sharing statements in the submitted manuscript and, like editors, may vary in the weight they place on more or less rigid data sharing plans when making their recommendations to editors.
MPIP also inquired when it might be acceptable to plan not to share deidentified individual patient data. Such situations might include when it is impossible to adequately assure the confidentiality of trial participants or where national regulations prohibit sharing. As stated above, however, the ICMJE does not currently require that data be shared (although some individual journals may). ICMJE does require a transparent statement of what will be done.