“Researchers who receive federal help consistently fail to report their results to the public. The government should hold them accountable….
Researchers using federal funds to conduct cancer trials — experiments involving drugs or medical devices that rely on volunteer subjects — were sometimes taking more than a year to report their results to the N.I.H., as required. “If you don’t report, the law says you shouldn’t get any funding,” he said, citing an investigation I had published in Stat with my colleague Talia Bronshtein. “Doc, I’m going to find out if it’s true, and if it’s true, I’m going to cut funding. That’s a promise.”
It was true then. It’s true now. More than 150 trials completed since 2017 by the N.I.H’s National Cancer Institute, which leads the $1.8 billion Moonshot effort, should have reported results by now. About two-thirds reported after their deadlines or not at all, according to a University of Oxford website that tracks clinical trials regulated by the Food and Drug Administration and National Institutes of Health. Some trial results are nearly two years overdue. Over all, government-sponsored scientists have complied less than half the time for trial results due since 2018. (A spokeswoman for the N.I.H. said, “We are willing to do all measures to ensure compliance with ClinicalTrials.gov results reporting.”)…
In 2016, Dr. Francis Collins, the director of the National Institutes of Health, announced that the agency would begin penalizing researchers for failing to comply with its reporting requirements. “We are serious about this,” he said at the time. Yet in the years since, neither the F.D.A. nor N.I.H. has enforced the law. …”
“A global, comprehensive and open access listing of approved anticancer drugs does not currently exist. Partial information is available from multiple sources, including regulatory authorities, national formularies and scientific agencies. Many such data sources include drugs used in oncology for supportive care, diagnostic or other non-antineoplastic uses. We describe a methodology to combine and cleanse relevant data from multiple sources to produce an open access database of drugs licensed specifically for therapeutic antineoplastic purposes. The resulting list is provided as an open access database, (http://www.redo-project.org/cancer-drugs-db/), so that it may be used by researchers as input for further research projects, for example literature-based text mining for drug repurposing.”
“Led by Europe’s largest academic trial sponsor, Austrian universities are now making their clinical trial results public at an impressive pace. In parallel, national medicines regulator BASG is intensifying its efforts to promote clinical trial transparency.
Overall, Austria’s 14 largest sponsors have made 37% of their due trial results public, compared to just 18% a year ago. Results are still missing for 233 long-completed trials.
Over the past year, the country’s three major medical universities alone have uploaded 65 trial results onto the European trial registry….”
Abstract: This project seeks to conduct language translation on metadata labels for research publications, attribution data, and clinical trials information to make data about medical research queriable in underserved languages through Wikidata and the Linked Open Web. This project has the benefit of distributing content through Wikipedia and Wikidata, which already have an annual userbase of a billion users and which already have established actionable standards to practice diversity, inclusion, openness, FAIRness, and transparency about program development. The impact will be localized access to basic research information in various Global South languages to integrate with existing community efforts for establishing the same. Although Wikidata development in this direction seems inevitable, the cultural and social exchange required to establish global multilingual research partnerships could begin now with support rather than later as a second phase effort for including the developing world. Wikipedia and Wikidata are established forums with an existing active userbase for multilingual research collaboration, but the research practices there still are immature. By applying metadata expertise through this project, we will elevate the current amateur development with more stable Linked Open Data compatibility to English language databases. Using the wiki distribution and discussion platform to develop the global conversation about data sharing will set good precedents for the trend of global research collaboration.
“Biopharma companies with the most effective and robust clinical trial disclosure programs often have one thing in common: a leadership that recognizes the importance of transparency beyond mere regulatory compliance.
These companies – primarily some of the largest pharmaceutical firms such as GlaxoSmithKline plc – have a commitment at the executive level to, for example, publish their disclosure policies, making generous commitments to protocol registration, results disclosure, plain language summaries, and the sharing of a broad range of clinical documents. They invest as well in both tools and company policies to meet these commitments.
In contrast, smaller companies typically delay in investing in the focused systems needed for even the modest goal of regulatory compliance, let alone providing for a strategic view into disclosure activities. For example, they often are making do with manual, spreadsheet-type approaches rather than a centralized review and monitoring system. But repercussions of having less effective programs can go well beyond just regulatory penalties. (See sidebar.) …”
The United States has mobilized the full force of its clinical research enterprise to address the Covid-19 pandemic, allocating billions of dollars to support timely research. As of January 2021, for example, the National Institutes of Health (NIH) had issued nearly a thousand awards cumulatively worth roughly $2 billion to support Covid-19 projects ranging from the development of medical products (including diagnostics and vaccines) to evaluations of population-specific risk factors and outcomes.1 Such initiatives, which have yielded new technologies and important evidence, illustrate the value of robust scientific infrastructure.
“Over the last few months, the Open Pharma Accessibility workstream has been hard at work, drafting our recommendations for the ‘minimum standard’ for multi-stakeholder plain language summaries of publications. These recommendations were the focus of the January 2021 Roundtable, during which we heard feedback on the recommendations from Open Pharma Members, Supporters and key Advisers.
Now, we’re asking for your input! The one-page recommendations document is available to read on our figshare page. If you have any thoughts, questions or comments, or if you just want your voice to be heard, you can email us at OxfordProject@pharmagenesis.com or join the conversation on Twitter. Please make sure to share your insights before the end of the consultation period on 31 March 2021!…”
• We constructed a corpus of RCT publications annotated with CONSORT checklist items.
• We developed text mining methods to identify methodology-related checklist items.
• A BioBERT-based model performs best in recognizing adequately reported items.
• A phrase-based method performs best in recognizing infrequently reported items.
• The corpus and the text mining methods can be used to address reporting transparency….”
“The best currently available evidence shows that around half of all trials go unreported: this means that doctors and patients see only a partial, biased fraction of the true evidence. We cannot make informed decisions about treatments unless all the data is reported. Under EU rules, from December 2016, all trials on the European Union Clinical Trials Register (EUCTR) should post results within 12 months of completion. There has never been a rule as simple and clear as this, anywhere in the world. Our EU Trials Tracker shows which organisations are compliant, and which aren’t. Our paper in the BMJ analysed the data as of January 2018, and found that only 49% of Europe’s clinical trials reported results in the register.
This website is one of a series of Trials Trackers produced by the EBM DataLab at the University of Oxford….”