The Evolution of Clinical Trial Data Sharing Practices

The clinical trial data sharing landscape is changing at a somewhat fast pace. Already, clinical reports that have been anonymized using a risk-based approach have been published by the EMA pursuant to Policy 0070. There are also efforts to simultaneously anonymize structured data, as well as clinical reports. This latter evolution introduces interesting risk measurement adjustments. Various countries around the world are introducing new laws and anonymization guidelines that are relevant for clinical trial data sharing practices.