Sponsors that plan to use registry data or create a registry to support a clinical trial should be prepared to consult with the FDA on their plan’s effectiveness.

Before launching a new study using registry data, sponsors should meet with the agency on five points:

• Whether the registry can deliver data on the trial’s target population;
• Which data elements would come from the registry, as opposed to other data sources;
• The plan for linking the registry to another data system, if appropriate;
• Planned methods for validating outcomes based on registry data; and
• Planned methods for validating the diagnosis of the disease being studied.

Comments on the draft guidance are due by Feb. 28.

Read the guidance at https://bit.ly/3Es3m6X.