The launch of new drugs is contingent on running safe and thorough clinical trials, but the clinical trials process takes an inordinate amount of time, particularly in patient recruitment. The use of big data analytics methodologies which leverage real databases of electronic medical records is accelerating the clinical trials process and making patient recruitment more efficient. However, use of EHR-databases brings with it the risk of loss of patient privacy. We examine the issues and outline best practice guidelines, in our article in the "Journal for Clinical Studies," September 2016. ©www.jforcs.com.
Recent developments have shown the real benefits arising from the use of big data analytics techniques to interrogate EHR-databases at hospitals directly. With the right software infrastructure, eligible patients can be discovered based on complex combinations of query criteria, and in real-time. Trial managers can unearth more candidates, quicker.
But this development raises questions for patient privacy: using these electronic methods, are an individual’s personal details at risk of arriving in unauthorized hands?
In this paper, we examine the technological and legislative environments, analyse the ensuing risks, and propose some best practice methods for mitigating these risks.
Link to September 2016 edition of the Journal for Clinical Studies: https://issuu.com/mark123/docs/50_jcs_september2016_web
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