By MMS Holdings and TrialAssure
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While global regulatory authorities routinely update clinical trial disclosure and transparency requirements, new regulations set to take effect in 2020 and 2021 will dramatically change how sponsors report clinical trial data.
Overall, the current regulations in both the EU/European Economic Area (EEA) and the US require the registration of new clinical trials and the posting of summary results for all completed studies, regardless of the approval status of the medicinal products.
The EU/EEA also requires the release of clinical reports and patient-level-data for trials approved, rejected, or withdrawn medicinal products. The US requires the study protocol, statistical analysis plan, and all amendments to be posted at the time study summary results are posted to ClinicalTrials.gov.
With these current practices in mind, it is important to review several challenges facing clinical trial sponsors in regard to clinical trial disclosure and transparency activities by region.
In the EU, clinical trial disclosure requirements are defined by Regulation (EU) No 536/2014 (known as the EU Clinical Trials Regulation), which was officially published on 27 May 2014 and is intended to replace EU Directive No. 2001/20/EC. While the EU Clinical Trial Regulation enforcement date is not yet confirmed, the regulation will take effect…