Featuring new FDA guidance on diversity and inclusion in clinical trials, further calls for COVID-19 vaccine clinical trial transparency, how the UN is promoting open science, discussions on the evolving ecosystem of scientific publishing and two recent analyses of predatory journal watch lists.
Encouraging diversity in clinical trials via US Food & Drug Administration
The US Food & Drug Administration (FDA) has issued guidance in the USA on how to improve the diversity of clinical trial participants. “Diseases don’t discriminate” so it’s vital that clinical trial populations reflect the demographics of the people whose health they aim to improve. The new FDA guidance outlines how to expand trial eligibility criteria and maximize enrolment strategies to promote the inclusion of under-represented populations.
Enhancing transparency in COVID-19 vaccine trials via STAT News
Pfizer’s encouraging update this week on its experimental COVID-19 vaccine candidate, which achieved an estimated 90% efficacy in its phase 3 study, has been making waves in mainstream news around the globe. However, a recent Pew survey shows that the general public in the USA has serious concerns regarding the trustworthiness of pharma and vaccines. In light of this, scientists and decision makers continue to stress that the most important thing we as pharma can do to build public trust, ensure scientific integrity and depoliticize science is to maintain high levels of transparency relating to clinical trial processes – which vaccine developers have committed to in a multi-signatory pledge previously covered in the Open Pharma digest here and here.
Building upon the United Nations’ (UN’s) multi-agency appeal for continuing open science beyond COVID-19, UN News has outlined how practising open science principles can aid the global vaccine race by answering the following questions.
- What is open science?
- Why is open science important?
- Why is it needed now?
- What is the impact of open science on the pandemic?
- What is the UN doing to promote open science?
Balancing the publishing ecosystem with the pandemic via Copyright Clearance Center
The evolving landscape of scientific publishing in response to the pandemic has been a common point of discussion as the industry adapts to and envisions a future beyond 2020. Here, Jennifer Goodrich, Director of Product Management at Copyright Clearance Center, contributes to the conversation, citing the knock-on financial effect of the pandemic on cancer research charities as an example of the rapidly changing research ecosystem.
Access vs. Predator via The Publication Plan
Various watch lists and directories exist to identify and index predatory journals, notably Beall’s list and Cabell’s list. Similarly, ‘safe lists’ also exist to catalogue journals with legitimate and ethical publishing practices. A recent analysis of both types of lists found that watch lists rarely provide the parameters they use to define predatory journals, whereas safe lists are typically more transparent about their criteria and often engender less controversy than their naming-and-shaming counterparts.
Krawczyk and Kulzcycki 2020: incredible predators via The Journal of Academic Librarianship
Part of the aforementioned controversy associated with predatory journal watch lists is the way in which some lists sometimes fail to distinguish open access journals from true predatory journals. This literature review of 280 publications that define predatory journals found many common themes stemming from the original Beall’s list that appear to overgeneralize the flaws in some open access journals, inappropriately conflating them with the unethical publishing practices of predatory journals.
We at Open Pharma would like to continue to encourage all our readers to look after themselves and their community and to continue to follow advice from their country’s government and health organizations.
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