Team : Dr. Erick Turner, Dr. Ben Goldacre and the OpenTrials team - PowerPoint PPT Presentation

• Team : Dr. Erick Turner, Dr. Ben Goldacre and the OpenTrials team at Open Knowledge International • OpenTrials aims to locate, match and share all publicly accessible data and documents, on all trials conducted, on all medicines and other treatments, globally • OpenTrialsFDA makes the clinical trial data from the FDA (until now hidden in the user-unfriendly Drugs@FDA portal more accessible and searchable • This will have a positive impact on clinical decision-making and lead to better medical services worldwide

How reporting bias ruins Evidence-based Medicine  risk ____________  benefit • Rx:  caution /  enthusiasm Bad drugs seem = good drugs • Lake Wobegon: “All kids above average” – Pervasive throughout medicine • Example: antidepressant medications... • Adapted from Turner EH, et al, NEJM Jan 17, 2008

Using FDA data to get true results Unpublished trials (k=23) Published but spun trials (k=11) • • 11 pigs with lipstick

Why are FDA reviews underutilized? • 97% of Cochrane reviewers failed to access regulatory data (Schroll et al, BMJ 2013) • User-unfriendly • Hard to navigate to – Takes 8 steps to download (Turner EH, BMJ 2013) • Hard to navigate through  Formatting obstacles – UNSEARCHABLE! • PDFs in image format—not text • No index • TOC yes, but no hyperlinks • Have to use your eyeballs & scroll through page by page – PDFs, either... • Multiple PDFs, e.g. medical review broken up into 4 parts • All “mooshed” together

OpenTrialsFDA Bring Drugs@FDA into the 21 st century https://fda.opentrials.net