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New Resources for a Healthy 2016
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Posted On January 19, 2016
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During the first phase of the project (scheduled for completion in March 2017), OpenTrials will collect all publicly available information about clinical trials and reconcile individual trial data discrepancies across multiple registries, using probabilistic record-linkage techniques to ensure accuracy. The project team will link to, aggregate, and unpack data from multiple sources, including clinical trial reports published in academic journals; perform optical character recognition (OCR) and index regulatory documents (from entities such as the U.S. Food and Drug Administration); link to and/or host the clinical study reports that detail methodology, expense, and outcomes; capture, match, and link structured data analyses to individual clinical trials (e.g., from the Agency for Healthcare Research and Quality’s Systematic Review Data Repository and Cochrane); and analyze trial paperwork, including patient information sheets, protocols, statistical analysis plans, and lay summaries. The technical road map for OpenTrials should be available within the first few months of 2016.

The OpenTrials homepage features a video that describes the presentation view for each target user group: researchers, patients, and transparency advocates. For example, the researchers’ view is designed to display individual clinical trial information that is available (in green), as well as indicate information that is not (in red). The goal is that researchers with knowledge of resources not currently available will upload links to improve the information about each trial. If a systematic review has been conducted to assess the methodological review of a trial, its score will be posted with a link to the systematic review.

Individual patient data will not be part of this project, although links to resources where that information might be available are likely to be included by the team or identified by researchers looking to enhance the data available about a particular trial. Researchers are encouraged to improve the site’s data (e.g., de-duplicate registry entries), contribute trial data to the site, or help make the existing data more discoverable.

In the future, the team intends to develop a scoreboard designed to drive behavior toward greater transparency. It may include the five biggest sponsors by number of trials sponsored (using overall scores and ranking) or the five biggest treatments by volume of prescriptions written, for example.

The success of the OpenTrials project rests with the engagement of researchers in identifying additional resources to be tapped, features that would aid researchers in their work, and problems the project might help resolve. This crowdsourced approach also relies on the ability to match large quantities of information concerning clinical trials, as well as transform unstructured information into accessible structured and tagged formats. Developments can be followed on Twitter.

Verily

According to The New York Times’ Conor Dougherty, Verily will take a “multidisciplinary approach to health and longevity, describing disease as a ‘continuum’ that will be fought with experts from different fields and divisions working on hardware such as medical devices, software that might use algorithms to look for health patterns,” and clinical studies. Verily will focus on chronic conditions that affect large numbers of individuals; diabetes is an initial big target.

The site is currently a bit thin, with only the names of a few of the members of its swiftly growing team and not-very-detailed descriptions of the research being conducted. Verily appears to prefer to allow the media to cover the partners joining its team by presenting links to articles published in scientific literature (e.g., Nature and Science), on technology sites (e.g., Wired), in business sources (e.g., Bloomberg and The Wall Street Journal), and in the mainstream press (e.g., The New York Times and NPR). Much of that coverage predates Verily’s transition from the life sciences division of Google X to its own independent company.

As Verily tackles disease, Google’s R&D company, Calico, explores the biology of longevity. Formed in 2013, Calico operates “as a high-tech research and development lab, creating medical products that its pharma partners will take to market” to extend life.

Health Literacy Tool Shed

Clear communication between healthcare providers and individuals navigating the healthcare system is an essential element of understanding options for care, which can affect health outcomes. The Health Literacy Tool Shed is a “curated online database of more than 100 empirically validated health literacy instruments” that can be used by organizations and researchers to assure that all populations are addressed in the most appropriate manner so they can make the most of the health resources available to them and appreciate the courses of treatment prescribed.

The tools in the database were published in peer-reviewed journals issued before 2014; additional resources will be added over time. In developing this resource, researchers “found gaps within some health literacy measures” and suggest specific research efforts that would be most helpful to conduct in the future.

Bonus Resources

Two reports issued under the Deloitte healthcare brand during the final weeks of 2015 concern the biopharmaceutical and life sciences sectors.

All pharmaceutical companies invest to some extent in R&D in the hopes of discovering new products to market in the future. Each year, Deloitte measures how well the leading life sciences companies have fared in terms of generating returns from their R&D investments. Learn how the industry made out in its latest annual report, “Measuring the Return From Pharmaceutical Innovation 2015: Transforming R&D Returns in Uncertain Times.”

Another report, “The Next Frontier of Drug Development and Approval,” identifies efforts by biopharmaceutical companies and regulatory agencies to improve the drug development and approval process.


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Barbie E. Keiser is an information resources management consultant located in the metropolitan Washington, D.C., area.

Email Barbie E. Keiser

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