JAMA Publishes Trial Results Delayed 5 Years. Here’s Why

“A treatment for shortening the painful episodes of sickle cell disease (SCD) is not effective, results published in JAMA indicate. But the effort it took to publish the findings is an important part of the story and reveal problems with data ownership, company motivations, and public resources that go well beyond a single clinical trial or experimental agent….”

Joint Statement on transparency and data integrity International Coalition of Medicines Regulatory Authorities (ICMRA) and WHO

“ICMRA1 and WHO call on the pharmaceutical industry to provide wide access to clinical data for all new medicines and vaccines (whether full or conditional approval, under emergency use, or rejected). Clinical trial reports should be published without redaction of confidential information for reasons of overriding public health interest….

Regulators continue to spend considerable resources negotiating transparency with sponsors. Both positive and negative clinically relevant data should be made available, while only personal data and individual patient data should be redacted. In any case, aggregated data are unlikely to lead to re-identification of personal data and techniques of anonymisation can be used….

 

Providing systematic public access to data supporting approvals and rejections of medicines reviewed by regulators, is long overdue despite existing initiatives, such as those from the European Medicines Agency and Health Canada. The COVID-19 pandemic has revealed how essential to public trust access to data is. ICMRA and WHO call on the pharmaceutical industry to commit, within short timelines, and without waiting for legal changes, to provide voluntary unrestricted access to trial results data for the benefit of public health.”

 

 

After the Pandemic: Has Medical Research Been Changed Forever? | MedPage Today

“medRxiv has been a terrific help to the scientific community during the pandemic. It has sped the communication of science and fostered interactions among scientists around the world. It is an open and rapid way to share pre-peer reviewed studies. For the most part, people seemed to have quickly realized that this is science in progress, and not to take it as truth — but as work open for comment. It has embedded the preprint culture in a way that I hope will be sustained and spread.

I am not aware of any harm that has accrued and I am aware that many good interactions have resulted from the sharing of the information. And it is certainly better than science by press release alone. Also, importantly, our screening process is intended to protect the public’s interest — safeguarding privacy, promoting registration, requiring ethics approval, and ensuring that dangerous claims are avoided….”

Guide to Accelerate Public Access to Research Data

“On behalf of the Association of American Universities (AAU) and the Association of Public and Land-grant Universities (APLU), we are pleased to present this Guide to Accelerate Public Access to Research Data. The Guide is intended to serve as a resource to help university administrators develop robust support systems to accelerate sharing of research data. It provides advice to universities concerning actions they can take, as well as the infrastructure and support that may be required to improve access to research data on their respective campuses. It also offers examples of how institutions are approaching specific challenges to providing public access to research data and results. Advancing public access to research data is important to improving transparency and reproducibility of scientific results, increasing scientific rigor and public trust in science, and — most importantly — accelerating the pace of discovery and innovation through the open sharing of research results. Additionally, it is vital that institutions develop and implement policies now to ensure consistency of data management plans across their campuses to guarantee full compliance with federal research agency data sharing requirements. Beyond the establishment of policies, universities must invest in the infrastructure and support necessary to achieve the desired aspirations and aims of the policies. The open sharing of the results of scientific research is a value our two associations have long fought to protect and preserve. It is also a value we must continue to uphold at all levels within our universities. This will mean overcoming the various institutional and cultural impediments which have, at times, hampered the open sharing of research data….”

Libraries and Librarians as Key Partners in Accelerating Public Access to Research Data – Association of Research Libraries

“The Association of American Universities (AAU) and the Association of Public and Land-grant Universities (APLU) have released their Guide to Accelerate Public Access to Research Data, the result of two years of work and national summits as part of the Accelerating Public Access to Research Data (APARD) program.

As a tool and framework for university administrators—specifically provosts, senior research officers, and IT leaders—the four-part guide is meant to “facilitate adoption of new institutional policies, procedures, and approaches that actively support and promote research data sharing, while at the same time ensuring rigor in the research process and the veracity of its intellectual outputs.” Included throughout the guide are recommendations, actions, and institutional examples and case studies for public access to research data….

Possible actions ARL member representatives can take with the release of the Guide to Accelerate Public Access to Research Data include:

Establish public access to research data as a library organization priority through incorporation into strategic plans, statements of principles, mission, and value statements.
Articulate the libraries’ role in accelerating public access to data with the mind frame of culture change. How is your library working from the bottom up (with faculty and graduate students), middle out (with department chairs and center directors) and top down (provosts, presidents, vice presidents for research, and others) to engage and influence public access to data?
Partner with campus stakeholders identified in the guide to begin mapping campus research data resources….”

Developing an objective, decentralised scholarly communication and evaluation system – YouTube

“This is our proposal for how we might create a radically new scholarly publishing system with the potential to disrupt the scholarly publishing industry. The proposed model is: (a) open, (b) objective, (c) crowd sourced and community-controlled, (d) decentralised, and (e) capable of generating prestige. Submitted articles are openly rated by researchers on multiple dimensions of interest (e.g., novelty, reliability, transparency) and ‘impact prediction algorithms’ are trained on these data to classify articles into journal ‘tiers’.

In time, with growing adoption, the highest impact tiers within such a system could develop sufficient prestige to rival even the most established of legacy journals (e.g., Nature). In return for their support, researchers would be rewarded with prestige, nuanced metrics, reduced fees, faster publication rates, and increased control over their outputs….”

AMWA-EMWA-ISMPP joint position statement on medical publications, preprints, and peer review

“The potential value of rapid publication should be weighed against the potential harm of inadequate validation of the final output. There is a danger that lowering the threshold of publication oversight sets a precedent that cannot be easily reversed, potentially eroding standards and public trust in medical science2.

We have joined in a multi-party consortium among three eminent professional organizations for medical communication professionals – AMWA, EMWA, and ISMPP – to advocate for the adoption of standards by all stakeholders to better ensure the integrity of published scientific and medical information. Thus, the following Joint Position Statement has been developed to provide practical and implementable suggestions to uphold data integrity and quality, and the transparency of medical publications….”

Preprints in perioperative medicine: immediacy for the greater good – British Journal of Anaesthesia

Abstract:  Medical and scientific journals spread developing knowledge by facilitating communication between physicians and scientists. Authors, readers, and the public rightfully expect rapid publication of rigorously reviewed high-quality papers. The COVID-19 pandemic has highlighted the importance of rapid dissemination and has put unprecedented demands on journals. There is genuine urgency to complete medical research and place the findings expeditiously into the public domain after expert peer review so that new findings can be used to improve patient care as soon as possible. The process of peer review is often a slow process, but is essential to ensure that changes in patient care are informed by careful and definitive research. Thus, journal editors must balance the potentially competing goals of immediacy and quality control.

 

The evolving role of preprints in the dissemination of COVID-19 research and their impact on the science communication landscape

Abstract:  The world continues to face a life-threatening viral pandemic. The virus underlying the Coronavirus Disease 2019 (COVID-19), Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), has caused over 98 million confirmed cases and 2.2 million deaths since January 2020. Although the most recent respiratory viral pandemic swept the globe only a decade ago, the way science operates and responds to current events has experienced a cultural shift in the interim. The scientific community has responded rapidly to the COVID-19 pandemic, releasing over 125,000 COVID-19–related scientific articles within 10 months of the first confirmed case, of which more than 30,000 were hosted by preprint servers. We focused our analysis on bioRxiv and medRxiv, 2 growing preprint servers for biomedical research, investigating the attributes of COVID-19 preprints, their access and usage rates, as well as characteristics of their propagation on online platforms. Our data provide evidence for increased scientific and public engagement with preprints related to COVID-19 (COVID-19 preprints are accessed more, cited more, and shared more on various online platforms than non-COVID-19 preprints), as well as changes in the use of preprints by journalists and policymakers. We also find evidence for changes in preprinting and publishing behaviour: COVID-19 preprints are shorter and reviewed faster. Our results highlight the unprecedented role of preprints and preprint servers in the dissemination of COVID-19 science and the impact of the pandemic on the scientific communication landscape.

 

 

 

Publishers Care about the Version of Record, Do Researchers? – The Scholarly Kitchen

“It was against this backdrop that I read Exploring Researcher Preference for the Version of Record, which reported on research Springer Nature conducted in collaboration with ResearchGate. It is perhaps obvious to caveat that it is in Springer Nature’s interests to use this study to reinforce the value of the VOR, a central position of a recent keynote by CEO Frank Vrancken Peeters at the APE 2021 conference.

The study was conducted “in situ” and leveraged the Springer Nature syndication pilot project that posted VOR articles for access on the ResearchGate platform. As Mithu Lucraft, Director for Content Marketing Strategy, of the Springer Nature Group and one of the study’s co-authors explained to me, the survey was presented to ResearchGate users that were logged in and who had interacted with at least one Springer Nature publication in the 60 days prior to the survey being live in October 2020. 

Importantly, survey participants were not only asked to choose which version of an article they prefer but also which versions they would feel comfortable using for different purposes. In many cases, participants indicated that multiple different versions would be acceptable for a given use, which indicates that a preprint or accepted manuscript can substitute for the VOR in some use cases but perhaps not all. …”