Health IT Analytics: FDA Makes Real-World Data Available on Google Cloud Platform. “The FDA’s MyStudies platform, a tool that aims to collect real-world data to improve clinical trials and advance medical research, is now available on Google Cloud Platform. Launched in November 2018, the MyStudies open-source technology platform supports drug, biologic, and device organizations as they collect and report real-world data for regulatory submissions.”
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.”
Weill Cornell Medicine: Scientists Build the First Global Database and Roadmap for CAR Therapy Clinical Trials. “Weill Cornell Medicine scientists have built the first global database of clinical trials testing a rapidly expanding approach to cancer treatment that involves genetically modifying immune cells to recognize specific targets on a patient’s cancer cells and attack them. By analyzing the approach, called chimeric antigen receptor (CAR) therapies, the scientists designed a ‘therapeutic roadmap’ that identifies all current therapies as well as additional cancers that can be treated with them.”
University at Buffalo: New web portal helps UB researchers spread the word about ongoing clinical trials. “Spreading the word about ongoing clinical trials at the University at Buffalo once was an incomplete and complicated process that posed challenges for both investigators and potential study participants. Now the UB Clinical and Translational Science Institute (CTSI), in close collaboration with the Office of the Vice President for Research and Economic Development, has recently set up an online tool that lists and updates every active clinical trial throughout UB. This Participate in Research portal streamlines the processes of posting and accessing information about ongoing trials.”
Dermatology Times: Improving the reporting of social media recruitment for clinical trials. “The popularity of social media has created a new opportunity for the research community to recruit study participants. Recent data indicate that nearly 70% of U.S. adults use some social media1. Coinciding with the surge of social media adoption, study teams increasingly report the use of social media to enhance recruitment in clinical research with promising but mixed results2,3. Recruitment of study participants is a significant problem, particularly in clinical trials. It remains a critical roadblock to successful clinical and translational research4,5.” This article has several references, thus the numbers.
Nature: How Facebook and Twitter could be the next disruptive force in clinical trials. “Amber Sapp was browsing the Internet late one night in August when she happened to find out that her 12-year-old son’s clinical trial had failed…. The thought of wasting Garrett’s limited time with a failed trial was hard enough. The news was all the more disturbing because it didn’t come from the trial organizers, but through a Facebook post from another parent.”
Outsourcing Pharma: Researchers target clinical trial recruitment challenges with online database. “Researchers recently published a report in the journal Clinical Trials discussing the Recruitment Research in Clinical triAls (ORRCA) project, which provides a searchable, online database of research relevant to clinical trial recruitment.”