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• Unpublished trials (k=23)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 21st century

https://fda.opentrials.net