NIH warns drug and device companies to post missing trial data 

“Hundreds of drug companies, medical device manufacturers, and universities owe the public a decade’s worth of missing data from clinical trials, federal officials warned last week.

New rules issued last week in the wake of a federal court ruling in February instructed clinical trial sponsors to submit missing data for trials conducted between 2007 and 2017 “as soon as possible.” For years, many trials conducted during that span have largely been exempted from reporting their data to ClinicalTrials.gov, a public database, meaning a decade of data about approved drugs and medical devices has never been made public.

The court’s ruling, and the federal government’s decision not to appeal it and instead to urge trial sponsors to submit the missing information, represent a major win for transparency advocates, who for years have fought to recover the decadelong gap in publicly available clinical trial data. …

The court ruling, and the resulting change in federal policy, come after years of reporting that has detailed how federal research agencies routinely fail to enforce their own rules regarding clinical trial transparency — which advocates say is critical for the public’s understanding of a given medicines’s safety and efficacy. …”

Open-Access Data and Computational Resources to Address COVID-19 | Data Science at NIH

“COVID-19 open-access data and computational resources are being provided by federal agencies, including NIH, public consortia, and private entities. These resources are freely available to researchers, and this page will be updated as more information becomes available. 

The Office of Data Science Strategy seeks to provide the research community with links to open-access data, computational, and supporting resources. These resources are being aggregated and posted for scientific and public health interests. Inclusion of a resource on this list does not mean it has been evaluated or endorsed by NIH….”

The NIH Preprint Pilot: A New Experiment for a New Era – NLM Musings from the Mezzanine

“Recognizing the growing interest in preprints, NLM is today launching the first phase of the NIH Preprint Pilot, which will test the viability of making preprints searchable in PubMed Central (PMC) and, by extension, discoverable in PubMed, starting with COVID-19 preprints reporting NIH-supported research.

To be clear, NLM is not building a preprint server for NIH investigators, nor are we developing a comprehensive preprint discovery resource. Rather, through this pilot, we plan to add a curated collection of preprints from eligible preprint servers to our established literature resources. In doing so, our goal is to improve scholarly communications by accelerating and expanding the findability of NIH research results.

With the encouragement of NIH leadership, NLM has been exploring ways to leverage its literature databases to help accelerate the discoverability and maximize the impact of NIH-supported research via preprints. The planned pilot builds on guidance released by NIH in March 2017, which encouraged NIH investigators to use preprints and other interim research products to speed the dissemination of research and enhance the rigor of their work through public comments and new scientific collaborations….”

NIH Preprint Pilot in PubMed Central

“NLM is preparing to launch a pilot project to test the viability of making preprints resulting from NIH-funded research available via PubMed Central (PMC). The primary goal of the NIH Preprint Pilot will be to explore approaches to increasing the discoverability of early NIH research results. The pilot will begin the week of June 8, 2020 and will run for a minimum of 12 months. Lessons learned during that time will inform future NLM efforts with preprints.

In its role as the repository for peer-reviewed manuscripts supported by NIH, PMC already makes available more than one million published papers resulting from NIH-supported research. Building on NIH guidance (NOT-OD-17-050) to investigators that encouraged the use of interim research products, such as preprints, to speed the dissemination and enhance the rigor of their work, NLM hopes this pilot will inform possible future steps to further accelerate discovery and access of papers that are developed with NIH funds and encourage the open and fast dissemination of NIH research results, when appropriate.

The pilot will initially focus on increasing the discoverability of preprints with NIH support relating to the current COVID-19 pandemic. NLM is leveraging the iSearch COVID-19 portfolio tool developed by the NIH Office of Portfolio Analysis to identify preprints reporting on COVID-19 research supported by the NIH intramural or extramural programs. This narrowly scoped first phase should allow NLM an opportunity to streamline workflows and refine the details of implementation with a set of articles for which there is a growing demand for accelerated access.

As curation and ingest workflows become scalable, NLM will expand the pilot to include preprints resulting from the broader spectrum of NIH research….”

NIH Preprint Pilot in PubMed Central

“NLM is preparing to launch a pilot project to test the viability of making preprints resulting from NIH-funded research available via PubMed Central (PMC). The primary goal of the NIH Preprint Pilot will be to explore approaches to increasing the discoverability of early NIH research results. The pilot will begin the week of June 8, 2020 and will run for a minimum of 12 months. Lessons learned during that time will inform future NLM efforts with preprints.

In its role as the repository for peer-reviewed manuscripts supported by NIH, PMC already makes available more than one million published papers resulting from NIH-supported research. Building on NIH guidance (NOT-OD-17-050) to investigators that encouraged the use of interim research products, such as preprints, to speed the dissemination and enhance the rigor of their work, NLM hopes this pilot will inform possible future steps to further accelerate discovery and access of papers that are developed with NIH funds and encourage the open and fast dissemination of NIH research results, when appropriate.

The pilot will initially focus on increasing the discoverability of preprints with NIH support relating to the current COVID-19 pandemic. NLM is leveraging the iSearch COVID-19 portfolio tool developed by the NIH Office of Portfolio Analysis to identify preprints reporting on COVID-19 research supported by the NIH intramural or extramural programs. This narrowly scoped first phase should allow NLM an opportunity to streamline workflows and refine the details of implementation with a set of articles for which there is a growing demand for accelerated access.

As curation and ingest workflows become scalable, NLM will expand the pilot to include preprints resulting from the broader spectrum of NIH research….”

NIH Preprint Pilot in PubMed Central

“NLM is preparing to launch a pilot project to test the viability of making preprints resulting from NIH-funded research available via PubMed Central (PMC). The primary goal of the NIH Preprint Pilot will be to explore approaches to increasing the discoverability of early NIH research results. The pilot will begin the week of June 8, 2020 and will run for a minimum of 12 months. Lessons learned during that time will inform future NLM efforts with preprints.

In its role as the repository for peer-reviewed manuscripts supported by NIH, PMC already makes available more than one million published papers resulting from NIH-supported research. Building on NIH guidance (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-050.html) to investigators that encouraged the use of interim research products, such as preprints, to speed the dissemination and enhance the rigor of their work, NLM hopes this pilot will inform possible future steps to further accelerate discovery and access of papers that are developed with NIH funds and encourage the open and fast dissemination of NIH research results, when appropriate.

The pilot will initially focus on increasing the discoverability of preprints with NIH support relating to the current COVID-19 pandemic. NLM is leveraging the iSearch COVID-19 portfolio tool (https://icite.od.nih.gov/covid19/search/) developed by the NIH Office of Portfolio Analysis to identify preprints reporting on COVID-19 research supported by the NIH intramural or extramural programs. This narrowly scoped first phase should allow NLM an opportunity to streamline workflows and refine the details of implementation with a set of articles for which there is a growing demand for accelerated access.

As curation and ingest workflows become scalable, NLM will expand the pilot to include preprints resulting from the broader spectrum of NIH research. Further, to enable NIH investigators to more easily report preprints as products of award, NLM will simplify the process for adding preprint citations to My Bibliography this summer.

NLM expects to engage with preprint servers throughout the pilot that include a significant volume of preprints with NIH support and meet the general expectations laid out in the 2017 NIH Guidance for selecting interim research product repositories.”

NIH Preprint Pilot in PubMed Central

“NLM is preparing to launch a pilot project to test the viability of making preprints resulting from NIH-funded research available via PubMed Central (PMC). The primary goal of the NIH Preprint Pilot will be to explore approaches to increasing the discoverability of early NIH research results. The pilot will begin the week of June 8, 2020 and will run for a minimum of 12 months. Lessons learned during that time will inform future NLM efforts with preprints.

In its role as the repository for peer-reviewed manuscripts supported by NIH, PMC already makes available more than one million published papers resulting from NIH-supported research. Building on NIH guidance (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-050.html) to investigators that encouraged the use of interim research products, such as preprints, to speed the dissemination and enhance the rigor of their work, NLM hopes this pilot will inform possible future steps to further accelerate discovery and access of papers that are developed with NIH funds and encourage the open and fast dissemination of NIH research results, when appropriate.

The pilot will initially focus on increasing the discoverability of preprints with NIH support relating to the current COVID-19 pandemic. NLM is leveraging the iSearch COVID-19 portfolio tool (https://icite.od.nih.gov/covid19/search/) developed by the NIH Office of Portfolio Analysis to identify preprints reporting on COVID-19 research supported by the NIH intramural or extramural programs. This narrowly scoped first phase should allow NLM an opportunity to streamline workflows and refine the details of implementation with a set of articles for which there is a growing demand for accelerated access.

As curation and ingest workflows become scalable, NLM will expand the pilot to include preprints resulting from the broader spectrum of NIH research. Further, to enable NIH investigators to more easily report preprints as products of award, NLM will simplify the process for adding preprint citations to My Bibliography this summer.

NLM expects to engage with preprint servers throughout the pilot that include a significant volume of preprints with NIH support and meet the general expectations laid out in the 2017 NIH Guidance for selecting interim research product repositories.”

NIH to Host Webinar on Sharing, Discovering, and Citing COVID-19 Data and Code in Generalist Repositories on April 24 | Data Science at NIH

“The National Library of Medicine (NLM) at the National Institutes of Health is hosting a free webinar for researchers to learn how to share, discover, and cite COVID-19 data and code in generalist repositories on April 24 from 2-3:45 p.m. ET.

The biomedical research community’s understanding of the novel coronavirus and the associated coronavirus disease (COVID-19) is rapidly evolving. Open science and the timely sharing of research data have played a critical role in advancing our understanding of COVID-19 and accelerating the pace of discovery.

Researchers will have an opportunity to hear from multiple generalist repositories about the ways each repository is supporting discoverability and reusability of COVID-19 data and associated code. The NLM will also provide an overview of available COVID-19 literature.”

New NIH Resource to Analyze COVID-19 Literature: The COVID-19 Portfolio Tool | NIH Extramural Nexus

“In the past few months, the scientific community has ramped up research in response to the SARS?CoV?2 pandemic; dozens of peer-reviewed articles and preprints on this topic are being added to the literature every day (Figure 1). This rapidly expanding effort has created challenges for scientists and the medical community who need to analyze thousands of scholarly articles for insights on the virus.

Recently, the National Library of Medicine at NIH joined the White House and key industry and university leaders to release the COVID-19 Research Dataset (CORD-19) and call on the AI community to develop text mining tools that help analyze and summarize the over 45,000 coronavirus articles. The CORD-19 dataset represents the most comprehensive, freely available library of machine readable coronavirus scholarly literature to date, with hundreds of AI tools and technologies already created.  

Building on this effort, the NIH Office of Portfolio Analysis (OPA) has assembled a comprehensive listing of COVID?19 publications and preprints that is freely available to the public and coupled with a user-friendly portfolio analysis interface for querying the full text and supplemental data. The COVID-19 portfolio is updated daily with new literature selected for inclusion by subject matter experts.  It draws upon NLM’s PubMed resource for citations and abstracts of published biomedical literature….”

Navigating the NIH Public Access Policy for Peer-Reviewed Manuscripts – Why and How to get a PMCID Number

“Manuscripts are required to be publicly available no later than 12 months following original publication date depending on the embargo period of the publisher; however, manuscripts are non-compliant if the PubMed Central Identification (PMCID) number has not been acquired 90 days after the original publication date. Steps to acquire a PMCID are provided below. Embargo periods for each journal in PMC can be found in the “Free Access” column on the PMC Journal List. The exact release date for each article under embargo is displayed in PMC search results, on the table of contents for the issue, or in the corresponding PubMed record. To obtain access to an article prior to its availability in PMC, individuals must contact the respective journal publisher directly….”