Background

The European Medicines Agency’s Policy on the Publication of Clinical Data for Medicinal Products for Human Use, commonly known as EMA’s Policy 0070, requires drug companies to proactively share the results of their clinical trials in the public domain after receiving a Marketing Authorization Application (MAA) decision from EMA. Following a review of a drug company’s Policy 0070 submission, EMA publishes this information in a publicly accessible online portal with the goal of helping researchers, doctors, and patients make informed decisions about treatments. 

For drug developers, complying with Policy 0070 imposes significant responsibilities under demanding timelines. They must anonymize the clinical data to protect clinical trial participants’ personal data (i.e., Personal Protected Data or PPD) and redact any Commercially Confidential Information (CCI) before submission. EMA regulators expect drug companies to balance the need to protect this sensitive information with the mandate to maximize the data utility for the public.

Challenges

• Our client needed to identify and anonymize the PPD and CCI present within the clinical documents, meeting regulator expectations for transparency while appropriately protecting this information from public disclosure.
• This process must be completed within a relatively short and well-defined timeline dictated by EMA.
• These tasks can be tedious, time-consuming, and resource-intensive, especially without prior experience and the use of specialized software tools.

Solution

• Certara’s Clinical Disclosure team leveraged prior regulator experience and feedback to develop a robust approach to consistent and compliant clinical data protection.
• Automated AI-enabled software, a standardized approach, and expert personnel helped complete the project ahead of schedule.
• Certara led the creation of a CCI library to address the protection of Commercially Confidential Information consistently.
• Certara developed a justification to support each proposed CCI redaction. The client approved this justification which was also accepted by the EMA.

이점

• Timely submission of a large dossier that was accepted and published by EMA.
• Retention of client for 2 additional submissions, totaling 5x the original submission volume.
• Robust documentation on the first project allowed for an even faster turnaround of the next 2 dossier requests.

Read this white paper to learn more about balancing data utility with data protection, streamlining your submission process, and complying with clinical trial transparency requirements.