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Welcome to Medical Communication News

Medical Communication News provides an executive summary of noteworthy articles pertaining to the medical communication industry. Distributed twice a month, this e-newsletter provides AMWA members with recent news, research, and trends in the field of medical communication. Read past issues in the online archive.
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Industry News
What a Massive Database of Retracted Papers Reveals About Science Publishing's 'Death Penalty'
Outcomes, Interventions and Funding in Randomized Research Published in High-Impact Journals
FDAAA Has Helped With Trial Registration and Results Reporting, Study Finds
First Analysis of 'Pre-registered' Studies Shows Sharp Rise in Null Findings
Evaluation of Industry Relationships Among Authors of Clinical Practice Guidelines in Gastroenterology
Learning About Preprints With PREreview
Predatory Journals: A Major Threat in Orthopaedic Research

AMWA News
Free On-Demand Webinar for November
CBI's 2nd Annual Medical Writers Summit

Industry News

What a Massive Database of Retracted Papers Reveals About Science Publishing's 'Death Penalty'
Science (10/25/18) Brainard, J; You, J

Retraction Watch, the leading resource tracking research papers that have been withdrawn from the literature, recently opened up its list as a public, searchable database. Science seized the opportunity to analyze about 10,500 retracted articles, peeling back the layers of a process that has been somewhat secretive. The numbers showed that retractions have grown from fewer than 100 a year prior to 2000 to nearly 1,000 per annum as of 2014, partly because the number of papers has mushroomed. The rate of retractions is actually fairly low, though, accounting for only about four out of every 10,000 papers pulled from journals. The other primary reason for the rise has more to do with a research community that has trained a more discerning eye on what makes it onto journal pages and less to do with runaway fraud. The number of publications that report retractions has jumped from 44 in 1997 to nearly 500 now, yet retractions per journal have barely budged. That, say experts, signals greater diligence in publishing circles, especially among the prestigious titles. "Retractions have increased because editorial practices are improving and journals are trying to encourage editors to take retractions seriously," says University of Michigan research ethics expert Nicholas Steneck. Another takeaway from Science's deep dive is that retractions are not interchangeable with wrongdoing. Fabrication, falsification, or plagiarism are cited in about half of all removals—and about 10 percent are pulled because of forged authorship, fake peer review, and other behaviors that are perceived as dishonest and unethical but that do not meet the official definition of misconduct. The other 40 percent have errors, reproducibility issues, or other flaws not related to fraud; but, because of the assumption of misconduct and accompanying stigma, efforts to clean up the literature have a tough time sticking. Chris Graf of the Committee on Publication Ethics says that combating the stigma could help editors make better decisions. "We need to be pretty clear that a retraction in the published literature is not the equivalent of, or a finding of, research misconduct," he says. "It is to serve a [different] purpose, which is to correct the published record." Some say that might be achieved if journals limit use of the term "retraction" and follow a standardized approach to disclosing the nature of a paper's problems and who is responsible.
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Outcomes, Interventions and Funding in Randomized Research Published in High-Impact Journals
Trials (10/29/18) Grey, P; Grey, A; Bolland, MJ

Researchers from the University of Auckland in New Zealand examined publishing trends in high-impact medical journals, with a specific focus on their potential influence on clinical practice. One concern was that trials lacking "hard" incomes—those that offer solid evidence on disease pathology and the patient experience—may be less reliable than "surrogate" outcomes. The investigators also wondered if industry-backed trials might include more studies with surrogate endpoints than hard ones. Finally, they took a hard look at the types of interventions evaluated, which they suspected might not reflect the diversity of clinical providers. The team worked with a sample of 360 randomized trials published in seven esteemed general medical journals and 10 specialty medical titles. The projects assessed hundreds of different interventions, but the review authors found that results from trials of novel devices were rarely published. They accounted for only 17 of 416 interventions, while drugs represented the majority (233). More than 60 percent of the trials presented a surrogate primary outcome only and 15 percent included a surrogate endpoint as part of a mixed primary outcome, leaving only roughly 25 percent that reported exclusively on a hard primary outcome. Lastly, fewer than 40 percent of the trials were funded with industry dollars. Although industry support was more common in trials appearing in specialty journals, these publications were no more likely than general medical journals to showcase research with positive results or surrogate outcomes.
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FDAAA Has Helped With Trial Registration and Results Reporting, Study Finds
Regulatory Focus (10/24/2018) Brennan, Z

A new study of trials supporting more than three dozen drugs approved by the Food and Drug Administration suggests that the FDA Amendments Act (FDAAA) has led to higher proportions of clinical trials that were registered and reporting results. The 2007 act calls for sponsors and investigators to register all clinical trials on ClinicalTrials.gov before participants are enrolled and to report results to the site within 30 days following approval of the indication. For their study, Yale and Harvard medical school researchers looked at 142 trials supporting new drug approvals between 2005 and 2014 for neuropsychiatric indications. "For clinical trials supporting the FDA approval of new drugs for neuropsychiatric indications, the proportions of trials that were registered and reporting results on ClinicalTrials.gov were significantly higher and publication bias was significantly lower after the passage of the FDAAA in 2007," the authors concluded. While the researchers say the FDAAA "likely contributed" to these results, they acknowledge that "other factors may also have been in play."
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First Analysis of 'Pre-registered' Studies Shows Sharp Rise in Null Findings
Nature (10/24/18) Warren, M

An emerging practice in scientific publishing involves pre-registering and peer-reviewing study protocols before the research is conducted. In the "registered report" format, journals provisionally agree to publish the final paper for protocols that pass peer-review, regardless of the outcomes. Proponents of the practice, used by about 140 journals at present, hope that it will reduce any publication bias for positive results. A new analysis from researchers at Cardiff University in the United Kingdom concludes that, compared with the general scientific literature, studies with pre-registered protocols had a greater likelihood of reporting null results. Their analysis included 113 registered reports in the biomedical and psychological fields and identified nearly 300 discrete hypotheses. In all, 61 percent of these hypotheses were not supported by the outcomes later published in the studies. While estimates for hypotheses not supported by research papers in the general scientific literature range from 5 percent to 20 percent, the rate for registered reports for novel studies in the U.K. study was 55 percent and 66 percent for registered reports for replication studies. The researchers note that another possible explanation for their results is that some scientists may employ this format for hypotheses they do not expect to succeed, as publication is almost guaranteed. Future research with a larger sample of reports, they say, will examine some of the questions raised in this study.
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Evaluation of Industry Relationships Among Authors of Clinical Practice Guidelines in Gastroenterology
JAMA Internal Medicine (10/29/18) Combs, TR; Scott, J; Jorski, A; et al.

Researchers scrutinized financial conflict of interest (FCOI), which can improperly skew clinical decisionmaking, within the gastroenterology field. The team from Oklahoma State University's Center for Health Sciences was specifically interested in if and how the authors of clinical practice guidelines (CPGs) in the specialty disclosed any pharmaceutical industry payments they may have received. A total of 83 authors of 15 CPGs—and their known FCOIs—were identified via the American College of Gastroenterology (ACG) website, while individual payment data was extracted from the 2014 to 2016 CMS OpenPayments database (OPD). The investigators determined that 53 percent of the authors received industry compensation—at a median total of $1,000—but the payments were acknowledged in both the CPG and on the OPD for only 19 percent of them. The same was true for 34 percent of the aggregate 146 FCOIs disclosed and 148 relationships confirmed on OPD. This low range of compliance may point to a need for additional ACG guidance, the researchers concluded. They recommend that the organization draw up new policies with specific expectations for FCOI disclosure among CPG authors in the gastroenterology field, and that the OPD undergo a reboot to improve its comprehensiveness and reliability.
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Learning About Preprints With PREreview
PLoS Blogs (10/18/2018) Whitaker, M

Three open-science advocates, who launched a platform to help scientists learn the preprint ropes, weigh in on how the movement can benefit researchers and their labs. Daniela Saderi, Samantha Hindle, and Monica Granados met through the Mozilla Open Workshop program and quickly realized their shared passion for preprints. They also realized, however, that takeup so far in the life sciences leaves something to be desired and that feedback to preprints is also lacking. PREreview was born out of the partners' desire to improve on this and spread the word. "We wanted to increase preprint awareness by encouraging more researchers to integrate preprints into journal clubs, and help capture and share those discussions as preprint reviews, to improve the reliability of the work and extend its usefulness to a broader scope," they explain. "By doing so, we hoped that we would provide a way to not just tell scientists how great preprints are, but to help them see for themselves—by integrating preprints into their everyday lives." With PREreview, subscribers can post their work, which is then assigned a digital object identifier (DOI) and indexed, and receive constructive criticism that they can incorporate before submitting a manuscript for final publication. Sharing findings with the broader research community, meanwhile, "adds to the value of the scientific discussion and opens new avenues for collaboration," Saderi, Hindle, and Granados insist. Moreover, they say, the site is valuable for early-career researchers, who rarely receive review invitations because they are unknown to journal editors or are thought less capable than senior researchers at breaking down their peers' work. Preprint work can help these scientists advance—for example, by putting potential collaborators in their path, positioning them for speaking engagements, and allowing them to share their work sooner so that they can cite it in grant and job applications. Among other future plans, PREreview hopes to further assist young scientists through a mentorship program currently in the works, which will match them with experienced reviewers.
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Predatory Journals: A Major Threat in Orthopaedic Research
International Orthopaedics (10/04/18) P. 1 Rupp, M; Anastasopoulou, L; Wintermeyer, E; et al.

In a new review, German researchers caution those writing about orthopedics to employ a variety of methods to avoid publishing in predatory publications. They compiled a "green" list of legitimate orthopedic research journals using both the Directory of Open-Access Journals (DOAJ) and journal citation reports from Thomson Reuters. The journal citation reports identified 96 genuine orthopedic journals, while 130 journals were identified on the DOAJ based on the keywords "orthopaedics, orthopedics, sports medicine, musculoskeletal, trauma, traumatology, osteoarthritis, osteoporosis, cartilage, bone, hand, shoulder, knee, hip, foot, wound." However, the researchers note, 21 journals identified on the DOAJ occurred overlapping with keywords. The authors also discuss ploys used by predatory publishers to encourage authors to submit to their journals, publications that they claim "threaten the credibility of academic publishing."
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AMWA News

Free On-Demand Webinar for November

This month's complimentary webinar for AMWA members is Clinical Study Report Development Pt 1. If you're a regulatory writer, you know that ICH E3 guidelines are vital to the strategic development of CSRs. This webinar will help you gain an understanding of how to interpret the guidelines through real-life practical experiences.

Be sure to access this webinar in AMWA Online Learning before the end of the month.
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CBI's 2nd Annual Medical Writers Summit

AMWA is the association partner for CBI's 2nd Annual Medical Writers Summit, taking place December 5-6 in Philadelphia, PA. Relevant for writers of all experience levels, this event provides an intimate setting for benchmarking with peers, connecting with colleagues, and taking an active role in your professional development.

CBI is offering AMWA members an exclusive discount of $500 off the registration fee. Use promo code YGH532 during registration to obtain your discount.
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News summaries © copyright 2018 SmithBucklin
November 7, 2018