Data sharing from clinical trials: lessons from the YODA Project – STAT

“This week, the National Academies of Science, Engineering, and Medicine are convening the workshop “Sharing Clinical Trial Data: Challenges and a Way Forward” just shy of five years after the Institute of Medicine released its seminal report, “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk.”

During this time, the scientific culture regarding data sharing has shifted. Just last week, the National Institutes of Health requested public comments on its draft “Policy for Data Management and Sharing.” In 2018, the International Committee of Medical Journal Editors began requiring data-sharing plans for clinical trials as a condition for publication in member journals. And platforms such as ClinicalStudyDataRequest.com, Project Data Sphere, and BioLINCC have emerged or grown. These platforms use a variety of different governance structures and models for data access, developed both with and without the support of industry or government….

The Yale Open Data Access (YODA) Project, which two of us (J.S.R. and H.M.K.) co-direct, launched in 2011 and formed a partnership with Johnson & Johnson in 2014. This five-year partnership offers an opportunity to reflect on some of the questions about sharing clinical trial data that may inform ongoing and future efforts….”

STRIDES Initiative | Data Science at NIH

“The NIH Science and Technology Research Infrastructure for Discovery, Experimentation, and Sustainability (STRIDES) Initiative allows NIH to explore the use of cloud environments to streamline NIH data use by partnering with commercial providers. NIH’s STRIDES Initiative provides cost-effective access to industry-leading partners to help advance biomedical research. These partnerships enable access to rich datasets and advanced computational infrastructure, tools, and services.

The STRIDES Initiative is one of many NIH-wide efforts to implement the NIH Strategic Plan for Data Science, which provides a roadmap for modernizing the NIH-funded biomedical data science ecosystem.

By leveraging the STRIDES Initiative, NIH and NIH-funded institutions can begin to create a robust, interconnected ecosystem that breaks down silos related to generating, analyzing, and sharing research data….”

Characteristics of mental health trials registered in ClinicalTrials.gov – ScienceDirect

Abstract:  The ClinicalTrials.gov registry was established in 2000 to address concerns about publication bias and public access to information about clinical trials. We aimed to evaluate differences between for-profit and non-profit sponsors of efficacy mental health trials registered in ClinicalTrials.gov on key trial characteristics that relate to data integrity. We also sought to evaluate whether the registry is fulfilling its purpose as a means of promoting transparency between researchers and the public by providing complete and quality information about the trials it contains. We found that trials tend to be small, use a placebo instead of an active comparator, and employ randomization and blinding. We discuss the implications of these design characteristics and the limitations of the registry.

 

Position statement on open access – Open Pharma

“Our immediate priority is to secure authors publishing company-funded research the same right to publish open access as authors publishing research funded by other sources, so that all research can be made free to read from the date of publication. This would enable pharmaceutical companies to follow the lead of other research funders in requiring all the research they fund to be published with open access, without impacting on journal choice.5-7 In order to provide publishers the time to adapt their policies and protect their copyright interests, any variant of Creative Commons or equivalent licence could be used….

Our long-term goal is to secure authors publishing company-funded research the same terms as authors publishing research funded by other sources, so that all research can be made free to read – and reuse – from the date of publication….”

Canada Opens the Door to Public Scrutiny of Clinical Drug Trials

“This past March, Canada’s department of health changed the way it handles the huge amount of data that companies submit when seeking approval for a new drug, biological treatment, or medical device — or a new use for an existing one. For the first time, Health Canada is making large chunks of this information publicly available after it approves or rejects applications.

Within 120 days of a decision, Health Canada will post clinical study reports on a new government online portal, starting with drugs that contain novel active ingredients and adding devices and other drugs over a four-year phase-in period. These company-generated documents, often running more than 1,000 pages, summarize the methods, goals, and results of clinical trials, which test the safety and efficacy of promising medical interventions. The reports play an important role in helping regulators make their decisions, along with other information, such as raw data about individual patients in clinical trials.

So far, Health Canada has posted reports for four newly approved drugs — one to treat plaque psoriasis in adults, two to treat two different types of skin cancer, and the fourth for advanced hormone-related breast cancer — and is preparing to release reports for another 13 drugs and three medical devices approved or rejected since March.

Canada’s move follows a similar policy enacted four years ago by the European Medicines Agency (EMA) of the European Union. The U.S. Food and Drug Administration (FDA), on the other hand, continues to treat this information as confidential to companies and rarely makes it public….”

Researchers concerned as tech giants choke off access to data | Times Higher Education (THE)

“Social scientists should be skipping through a data paradise, delving deeper than ever before into the workings of our parallel, online world using billions upon billions of likes, shares, comments and emojis.

But researchers are sounding the alarm that the opposite is happening. They fear that their freedom to access and study this global data explosion is being steadily narrowed by the social media companies and platforms that hold the information.

 

The restrictions means that academics – and by extension regulators, the public and politicians – have little idea what is really going on online, be it fake news, extremist propaganda or Russian disinformation….”

Researchers concerned as tech giants choke off access to data | Times Higher Education (THE)

“Social scientists should be skipping through a data paradise, delving deeper than ever before into the workings of our parallel, online world using billions upon billions of likes, shares, comments and emojis.

But researchers are sounding the alarm that the opposite is happening. They fear that their freedom to access and study this global data explosion is being steadily narrowed by the social media companies and platforms that hold the information.

 

The restrictions means that academics – and by extension regulators, the public and politicians – have little idea what is really going on online, be it fake news, extremist propaganda or Russian disinformation….”

Open data on industry payments to healthcare providers reveal potential hidden costs to the public | Nature Communications

Abstract:  Healthcare industry players make payments to medical providers for non-research expenses. While these payments may pose conflicts of interest, their relationship with overall healthcare costs remains largely unknown. In this study, we linked Open Payments data on providers’ industry payments with Medicare data on healthcare costs. We investigated 374,766 providers’ industry payments and healthcare costs. We demonstrate that providers receiving higher amounts of industry payments tend to bill higher drug and medical costs. Specifically, we find that a 10% increase in industry payments is associated with 1.3% higher medical and 1.8% higher drug costs. For a typical provider, for example, a 10% or $25 increase in annual industry payments would be associated with approximately $1,100 higher medical costs and $100 higher drug costs. Furthermore, the association between payments and healthcare costs varies markedly across states and correlates with political leaning, being stronger in more conservative states.

CSIRO launches open-access virtual core library – Australian Mining

“CSIRO [Commonwealth Scientific and Industrial Research Organisation] has introduced the National Virtual Core Library (NVCL), a digitised collection of 10 million metres of drill core estimated to be archived in warehouses around Australia.

The cores are analysed using HyLogger, an automated sampling system that generates digital images, surface profiles and mineralogical interpretations.

The data is then compared and mapped with other adjacent cores to build a bigger picture of what’s underground in a given area, providing ‘a new set of eyes’ to geologists, so they can map mineral composition rapidly and objectively….”

CSIRO launches open-access virtual core library – Australian Mining

“CSIRO [Commonwealth Scientific and Industrial Research Organisation] has introduced the National Virtual Core Library (NVCL), a digitised collection of 10 million metres of drill core estimated to be archived in warehouses around Australia.

The cores are analysed using HyLogger, an automated sampling system that generates digital images, surface profiles and mineralogical interpretations.

The data is then compared and mapped with other adjacent cores to build a bigger picture of what’s underground in a given area, providing ‘a new set of eyes’ to geologists, so they can map mineral composition rapidly and objectively….”