Ten Drugmakers To Cooperate ..... Accelerating Drug Development.

Standardizing clinical data dictionaries for drug trials is one of the biggest obstacles within many companies.  It is slow progress as each clinical project may have unique medical hx questionare, efficacy data, other.  However, there are obvious common core data items across all studies and they should be consistent to label by the same "name" like gender vs sex, or adverse event "intensity" vs adverse event "severity".  They are now trying to map this area in the data to merge it.  The FDA is certainly pushing for standardized data from companies so they can more quickly access it and start the review.  Each pharma or biotech was submitting their own "data flavor" and this is what slows down the FDA review.  The reviewer had to sit with someone from each company for each drug submission to find out how they organized and setup their data tables, etc. Kinda crazy - - it's like having to learn a different software and the specific clinical project steps to review for each drug submission! 

 In the past, collecting laboratory data from different investigator sites who used different reference labs was a big issue with foreign studies.  Different countries and referral labs used different "units" and methodologies.  It was very difficult to merge the data across multiple studies for a huge clinical drug project.  Lots of data conversions required so you were not mixing apples and oranges to read the labs within the same reference ranges.  In the US at least much of the research now uses centralized reference labs with direct interface to pharma companies for electronic data transfer between databases. 

But this is slow going........