EMA Policy 0070 is a main driver for clinical trial data anonymization. This regulation requires publishing clinical data in regulatory submissions of investigational drugs. This policy aims to increase the transparency of drug development and to foster scientific research innovation.
However, publishing clinical data also risks disclosing sensitive information that could compromise the privacy of trial participants or the confidentiality of commercial trade secrets. Therefore, EMA Policy 0070 requires that both personal protected data and commercially confidential information/confidential business information (CCI/CBI)are anonymized before publication.
To make identifying sensitive data easier, many pharmaceutical companies are moving towards a lean-authoring model of regulatory documents with public disclosure in mind. Over the previous two years, Certara has anonymized over 1 million pages across 30 medical dossiers for both the European Medicines Agency and Health Canada regulatory authorities. We achieved this by developing a three-step authoring process for fast, consistent, and compliant data protection. This includes:
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- Omitting unnecessary information (such as CCI/CBI) from being included in study documents
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- Limiting personal data to only appear in specific sections within clinical study reports
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- Committing to terminology harmonization to take advantage of natural language processing tools to automate the identification and protection of sensitive information
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- Authoring medical documents with only the necessary content, isolating personally identifying content in certain report sections, and using consistent terminology allow for faster, more consistent and accurate data processing and protection.
Learning Objectives
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- Illustrate the effect that medical writing has on clinical data disclosure.
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- Demonstrate how lean authoring with disclosure in mind can help minimize the resources required to anonymize documents for public disclosure.
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- Identify the key aspects of data privacy that can be enhanced by lean medical writing.
Who Should Watch?
This presentation will benefit anyone who manages, writes, or anonymizes clinical documents. The process improvements discussed can be employed by departments such as legal, management, regulatory affairs, and even investigators and medical staff.