No records found for 220 clinical trials of orphan drugs approved by the FDA

"A new study has found widespread gaps and inconsistencies in clinical trials of orphan drugs, suggesting suboptimal data management by the FDA and failures by some pharma companies to consistently register clinical trials and keep public registry records up to date.

The study team compared publicly available FDA documents and ClinicalTrials.gov registry data for 63 orphan drugs approved between 2009-2019.

FDA documents identified 422 clinical trials linked to these drug approvals, but the team was only able to find 202 related trials in the ClinicalTrials.gov registry. 220 trials could not be located on the registry.\

For those trials with data available in both types of sources, the number of trial participants recruited did not match in over 30% of cases...."