An Analysis of Anonymization Practices
Applied Clinical Trials has recently published Dr Khaled El Emam’s recent article, An Analysis of Anonymization Practices in Initial Data Releases Pursuant to EMA Policy 0070.
An excerpt from his article:
On Oct. 2, 2014, the European Medicines Agency (EMA) published Policy 0070, which required pharmaceutical companies to provide the agency with anonymized clinical trial information subsequent to a decision through the centralized marketing authorization procedure. A two-phase, stepwise approach was adopted, where phase one consists of marketing authorization holders (MAHs) submitting anonymized clinical reports, and phase two consists of MAHs submitting anonymized structured patient level listings. Phase one is already in place and applies to procedures submitted from Jan. 1, 2015. Phase two is expected to commence at some point in the near future. Our focus in this article is only on phase one.
The EMA will then make these clinical reports available for public sharing through its clinical data portal. These Policy 0070 submissions must include an anonymization report as well, which describes the methods used to anonymize the clinical reports.
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