Science: FDA and NIH let clinical trial sponsors keep results secret and break the law

Science: FDA and NIH let clinical trial sponsors keep results secret and break the law. “Science examined more than 4700 trials whose results should have been posted on the NIH website ClinicalTrials.gov under the 2017 rule. Reporting rates by most large pharmaceutical companies and some universities have improved sharply, but performance by many other trial sponsors—including, ironically, NIH itself—was lackluster. Those sponsors, typically either the institution conducting a trial or its funder, must deposit results and other data within 1 year of completing a trial. But of 184 sponsor organizations with at least five trials due as of 25 September 2019, 30 companies, universities, or medical centers never met a single deadline.”

Everyone’s Voice Matters: Making Science Open and Accessible to the Public (NLM Musings from the Mezzanine)

NLM Musings from the Mezzanine: Everyone’s Voice Matters: Making Science Open and Accessible to the Public. “Last month, the National Institutes of Health (NIH) released its Draft NIH Policy for Data Management and Sharing and Supplemental Draft Guidance (Draft NIH Policy), making it available for public comment. Comments are due by January 10, 2020. Because everyone’s voice matters, I’m calling on the Musings audience to review the draft and offer your perspectives on this policy now!”

MobiHealthNews: FDA, NIH’s newest app asks clinicians to log case data when treating difficult infections

MobiHealthNews: FDA, NIH’s newest app asks clinicians to log case data when treating difficult infections. “The FDA and National Institutes of Health are tapping the clinical community and a newly launched mobile platform in its search for novel infectious disease interventions. Called CURE ID, the online data repository will allow clinicians to report instances in which existing FDA-approved drugs are used to successfully treat infections.”

Health IT Analytics: NIH, FDA Launch Database for Parkinson’s Disease Precision Medicine

Health IT Analytics: NIH, FDA Launch Database for Parkinson’s Disease Precision Medicine. “The Accelerating Medicines Partnership (AMP) program for Parkinson’s disease (PD) has launched a data portal to help researchers develop precision medicine therapies for the condition. The portal includes de-identified data collected from 4,298 patients with Parkinson’s and will enable researchers to study complex data sets and perform genome-wide analyses.”

CNET: Google ditched project to release 100,000 X-ray images, amid privacy concerns

CNET: Google ditched project to release 100,000 X-ray images, amid privacy concerns. “Google was getting ready to publicly release more than 100,000 human X-ray images through a partnership with the US National Institutes of Health, before abandoning the plan last minute after the government agency raised privacy concerns, says a Friday report by The Washington Post.”

National Institutes of Health: Five Petabytes of Sequence Read Archive Data Now in the Cloud

National Institutes of Health: Five Petabytes of Sequence Read Archive Data Now in the Cloud. “The National Center for Biomedical Information (NCBI) at the National Library of Medicine (NLM) recently moved the five petabytes of public SRA data to the cloud with support from the National Institutes of Health (NIH) Science and Technology Research Infrastructure for Discovery, Experimentation, and Sustainability (STRIDES) Initiative. These data include a variety of genomes, gene expression data, and more.”

NIH: The “PROMIS” of Computer-Based Medical Records

NIH: The “PROMIS” of Computer-Based Medical Records. “The National Library of Medicine recently acquired the Patient/Problem Oriented Medical Record System Archives, a collection of materials related to the development of an early computer system for organizing patient data and diagnostic decision-making. Jan Schultz generously contributed archival materials from his work with Dr. Larry Weed at the PROMIS lab at the University of Vermont. NLM archivist John Rees asked Jan Schultz about his perspective on the early history of electronic medical records.”