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Medical Communication News
provides an executive summary of noteworthy articles exploring recent news, research, and trends in the field of medical communication. Read past issues in the online archive
FDA Proposes New Rule on Reporting Requirements
FDA News Release (07/23/20)
A proposed new rule from the U.S. Food and Drug Administration (FDA) provides guidance on the annual summary required of sponsors and manufacturers under the Right to Try Act. The law—also known as the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2017—"provides a pathway for patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in a clinical trial, to access certain unapproved treatments," according to FDA. Anand Shah, MD, FDA's Deputy Commissioner for Medical and Scientific Affairs, explains the "proposed rule builds on the FDA's long-standing dedication to enhancing access for patients who are facing life-threatening diseases or conditions and our continued commitment to transparency." Comments on the proposed rule
are due by September 22, 2020.
Open-Access Plan S to Allow Publishing in Any Journal
Nature (07/16/20) Van Noorden, R
The coalition behind the Plan S open-access (OA) initiative announced a new policy under which funded researchers could publish in any journal, including ones requiring subscriptions. Researchers funded by Plan S agencies must publish their work OA. However, if their chosen journal does not offer that option, they can instead post an author accepted manuscript (AAM) in an online repository. The AAM would then be shared under a liberal Creative Commons Attribution (CC-BY) license with no embargo. Although the combination of CC-BY licensing and no embargo is uncommon for AAMs, Coalition S announced that Plan S funders will require authors to apply for CC-BY licenses for their AAMs as part of the grant conditions. They will then preserve the right to share their manuscripts, regardless of what a journal's publishing agreement states. According to Robert Kiley, head of open research at Wellcome, it is hoped that publishers will update their agreements to permit authors to share AAMs under a CC-BY license online. If that does not occur, the grant condition "has legal precedence over any later publishing agreement," he says. However, Kiley cautions that a publisher could potentially refuse to consider such manuscripts at all.
Healthcare Professionals' Perceptions of Infographics Within Medical Information Response Letters
Therapeutic Innovation & Regulatory Science (07/28/20) Patel, Z; Patel, C; Oreper, J; et al.
The Medical Information team at Novo Nordisk Inc. added infographics to Standard Response Documents (SRDs) in a move intended to further improve the readability and comprehension of the content. To gauge the impact of the new material, the company enlisted health care professional (HCP) participation in a two-part survey. For the quantitative arm of the study, 41 out of 47 respondents (87 percent) agreed or strongly agreed the infographic was easy to interpret. A total of 40 participants (85 percent) also agreed or strongly agreed the infographic helped to resolve their question about the product. In the qualitative assessment, one-on-one telephone interviews were held with 25 HCPs focused around two SRDs. Twenty of those participants appreciated the presentation of the infographics and considered them appealing to the eye. Most also agreed the infographics provided information to effectively address their product inquiries and influenced clinical decision making. The survey results suggest infographics are a viable resource within the context of response letters meant to better HCP understanding of pharmaceutical products. They could foster progress in how drug manufacturers present medical information, the researchers conclude.
Commercial Payments Linked to Biased Articles in Medical Journals
UT News (07/27/20)
While the record shows journal authors with financial conflicts of interest put a more positive spin on pharmaceutical products they write about, new research highlights another area of concern tied to commercial payments. Researchers at The University of Texas at Austin reviewed 128,781 articles published in 159 medical journals, looking specifically at conflicts of interest. Articles appearing in journals accepting reprint fees were almost three times as likely to have been penned by authors who receive money from the industry. Publications' practice of accepting ad revenue or their ownership by a multinational publishing giant had no influence on the probability of an author conflict of interest. "If we're going to make sure that medical journals are publishing the best science available, we need to focus on the commercial relationships that actually have an effect," says lead study author S. Scott Graham. "The issue with reprints also suggests that academics may need to take open access publishing even more seriously." Graham and his team report their findings in PLOS ONE.
Characteristics and Strength of Evidence of COVID-19 Studies Registered on ClinicalTrials.gov
JAMA Internal Medicine (07/27/20) Pundi, K; Perino, AC; Harrington, RA; et al.
Researchers took a close look at the quality of COVID-19 research, which has poured in—at times without the benefit of peer review—since the pandemic began. To gauge what share of those projects might achieve Oxford Centre for Evidence-Based Medicine (OCEBM) level 2 results, the top rating for individual studies, the team combed the literature for relevant work. A total of 911 interventional studies and 640 observational studies matched the inclusion criteria. Using a cross-sectional approach, the researchers characterized the studies and measured their methodological strength. Based on properties such as blinding, multisite enrollment, placebo control, prospective design, and large study sample size, only 451 of the 1,551 studies—or about 29 percent—were candidates for OCEBM level 2 evidence. More than three-quarters of the investigations took place at a single location, for example, rather than across multiple centers. Moreover, among the 644 randomized clinical trials examined, just 75—or 11.3 percent—were blinded, placebo-controlled, and had participation from two or more study centers. The analysis results suggest a high presence of low-quality COVID-19 evidence, which the authors find worrisome. "Rapid dissemination of studies with low-quality evidence studies can influence public opinion, government actions, and clinical practice in potentially harmful ways, especially with a rising tide of COVID-19 study dissemination via preprint or other strategies ahead of peer review," they write. The researchers call on "institutional review boards to work with investigators to ensure that experimental research involving human participants is sufficiently well designed to achieve the goal of generating clinically meaningful evidence."
Most Top Clinical Journals Now Allow 'Preprint' Posting Before Peer Review and Publication
Reuters (07/24/20) Carroll, L
A survey of 100 leading journals shows preprints have become a widely used and acceptable practice in medical publishing, representing a huge shift from the past. Only the Journal of Allergy and Clinical Immunology completely bans preprints, while 13 others allow them on a case-by-case basis. However, the overwhelming majority—86 out of 100—do not prohibit the format in any way. The trend toward preprints likely got a boost from today's public health crisis, according to study co-author Harlan Krumholz, MD, a cardiologist and Yale University professor who helped to found the preprint server medRxiv.org. "We were growing over time, but the COVID-19 pandemic brought everything into bright relief and made it clear that there was a need to share research immediately," he said. "The platform got a lot more attention and this probably pushed us five years ahead." As for the small number of journals still resisting the movement, Krumholz predicts they will change gears as refusing preprints eventually becomes a disadvantage. He and his colleagues published their findings in JAMA Network Open.
Distinguishing Predatory From Reputable Publishing Practices
Journal of Managed Care & Specialty Pharmacy (08/01/20) Vol. 26, No. 8, P. 956 Happe, LE
Peer-reviewed literature is critical to managed care pharmacy practice, making it essential for managed care authors and researchers to be able to distinguish between predatory journals and reputable ones. Predatory publications are often marked by a lack of transparency regarding publication fees, aggressive solicitation of contributors regardless of their relevant skill set, and may also closely imitate the names of reputable journals, writes Laura E. Happe, editor-in-chief, Journal of Managed Care & Specialty Pharmacy. "Left unchecked, these journals have the potential to threaten the evidence base relied on by managed care pharmacists," she notes. However, she says, there are five practices reputable journals follow. These include using peer reviewers who are experts in their fields to carefully review submitted papers; having an editorial board with experts in relevant fields; and following recognized publishing standards, recommending best practices for authorship designation, journal management, and other topics. Additionally, reputable journals are transparent about any fees they charge, and they are indexed in searchable databases requiring a selection process for inclusion. "Although peer-reviewed publishing must evolve to keep pace with the rapid growth of data and analytics in medicine, the field can never compromise on ethical and rigorous publishing practices," Happe concludes.
Save the Date for #AMWA2020 Virtual Conference
Join us October 20-22, 2020 to celebrate AMWA’s 80 years as the leading resource for medical communicators working to create clear communications that lead to better health and well-being. Our virtual format will allow us to explore ideas and solutions together, build meaningful connections, and envision a bright future for medical communication. We hope you’ll join us for this historic event! Registration for the AMWA 2020 Medical Writing & Communication Conference
will open in mid-August.
August's Complimentary Recorded Webinar
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