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Recently I attended two key conferences: Big Data in Healthcare, a Phacilitate-hosted conference in Washington DC and a conference on EU Data transparency hosted by CBI in Philadelphia. Both had an excellent set of presenters and offered new insights, however there was a notable lack of crossover between the two topics and audiences. In the present environment, there is a cry for clinical data transparency and for the results of all trials to be made available in the public arena.

Clinical trial data obtained by commercial sponsors has for the last 20 to 30 years, been from well-controlled double data entered or enabled by sophisticated programs. Every data point is cleaned and can be accounted for in the data sets. With the advent of Big Data, a term of mixed meaning in many people’s minds, the data can be from many disparate sources and “not clean”, which begs the question what data should be made available? The conglomerate data from wearable devices, for example, will not be clean data but will nonetheless provide us with a rich source of information as to the performance of a new drug, biologic or device. How does this data get redacted and provided in the public arena? The summary data sets perhaps? The individual subject mean?

As we move into the realm of data transparency for all clinical trials and collection of ever larger, less clean amounts of Big Data we are left with more questions, which will require careful navigation and dissemination. At the present time, the data repositories for clinical trial results, such as www.clinicaltrials.gov, do not really allow for this true data transparency.

How do you see Big Data and data transparency being resolved? Join the discussion by leaving a comment.

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