Austria: Rapid progress on clinical trial reporting

“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….”

Clinical Data Transparency Is Big Challenge For Smaller Sponsors :: Pink Sheet

“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.) …”

Introducing the Open Pharma recommendations for multi-stakeholder plain language summaries of publications: now inviting public consultation – Open Pharma – Innovations in medical publishing

“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!…”

Toward assessing clinical trial publications for reporting transparency – ScienceDirect

“Highlights

 

• 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….”

 

EU Trials Tracker — Who’s not sharing clinical trial results?

“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….”

EU Trials Tracker — Who’s not sharing clinical trial results?

“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….”

Toward assessing clinical trial publications for reporting transparency – ScienceDirect

“Highlights

 

• 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….”

 

To Prevent the Resurgence of the Pandemic, Can We Talk About Open-Source Research? – Center for Economic and Policy Research

“But suppose Pfizer, Moderna, and the rest insist they are not selling, or at least not at a reasonable price. Then we go route two. We offer big bucks directly to the people who have this knowledge. Suppose we offer $5-$10 million to key engineers for a couple of months to work with engineers around the world. Yeah, Pfizer and Moderna can sue them. We’ll pick up the tab for their legal fees and any money they could lose in settlements. The sums involved are trivial relative to lives that could be saved and the damage prevented by more rapid diffusion of the vaccines.

If these companies actually pursued lawsuits it would also be a great teaching opportunity. It would show the world how single-mindedly these companies pursue profits and how incredibly corrupting the current system of patent monopoly financing is.

Okay, but let’s say we can overcome the obstacles and get the knowledge from these companies freely dispensed around the world. We still have the claim that there are physical limits to how rapidly vaccines can be produced.

There are two points here. First, while there clearly are limits, we can still move more quickly in the relevant time frame. No one had vaccines in March of 2019, but the leading producers had the capacity to produce tens of millions of doses a month by November, a period of less than eight months….”

Pistoia Alliance | Collaborate to Innovate Life Science R&D

“We are a global, not-for-profit members’ organization working to lower barriers to innovation in life science and healthcare R&D through pre-competitive collaboration….

The Pistoia Alliance is a global, not-for-profit members’ organization conceived in 2007 and incorporated in 2009 by representatives of AstraZeneca, GSK, Novartis and Pfizer who met at a conference in Pistoia, Italy. This group shared the opinion that life science R&D was changing beyond recognition, and that organizations could not afford to ‘go it alone’ in order to integrate emerging technologies and continue to deliver life-changing therapies to patients. The Pistoia Alliance’s projects help to overcome common obstacles to innovation and to transform R&D – whether identifying the root causes of inefficiencies, working with regulators to adopt new standards, or helping researchers implement AI effectively. There are currently more than 100 member companies – ranging from global organisations, to medium enterprises, to start-ups, to individuals – collaborating as equals on projects that generate value for the worldwide life sciences community….”

Patient involvement in medical publications – PharmaTimes

“A main finding from resurveyed editors was that a combined 89% said there is no suitable formal role for patients as reviewers of medical literature. Asked to interpret prior results, 26% said that a lack of patient involvement may reflect a lag in acceptance and/or implementation of such processes overall, but more telling was that almost two-thirds (64%) maintained that drives to include patients in peer-reviewed journals’ editorial processes – unlike in drug development and/or clinical trial design – may need re-evaluation. That said, a number of editors did suggest that patients could serve valuable roles reviewing specific types of articles, for example, those dealing with adherence or quality of life….”

Progress Towards a Modernized ClinicalTrials.gov – NLM Musings from the Mezzanine

“In 2019, NLM introduced a multi-year effort to modernize ClinicalTrials.gov, the world’s largest publicly accessible database of privately and publicly funded clinical trials. This effort was launched with a commitment to engage with and serve the millions of users who rely on this essential resource — with a focus on delivering an improved user experience on an updated platform that will accommodate growth and enhance efficiency.

In keeping with that promise, NLM has embarked on several stakeholder activities as part of the roadmap for modernization that we want to highlight in this post. We will also continue to share opportunities for involvement and invite you to join us for an upcoming webinar on February 18, 2021 at 3 pm ET to learn more about our modernization efforts….”

Europe hints at patent grab from Big Pharma – POLITICO

“Ever so softly, European politicians are beginning to voice a once unthinkable threat by suggesting they could snatch patents from drug companies to make up for massive shortfalls in the supply of coronavirus vaccines.

Big Pharma businesses have for many years regarded EU countries as unquestioningly loyal allies over intellectual property rights in the international trade arena. The EU could always be relied upon to defend U.S., Japanese and European drugmakers from poor nations in Africa and South Asia that have long wanted the recipe of critical medicines to be handed over to generic manufacturers.

But fury over the inability of companies to deliver on contracts amid the COVID-19 pandemic means that now even European politicians, from the Italian parliament to German Economy Minister Peter Altmaier, are arguing, albeit cautiously, that patents may no longer be as sacrosanct as they once were….”