TGA miscounted clinical trial numbers

The Therapeutic Goods Administration has admitted to miscounting the number of Australian clinical trials initiated between 2009 and 2012.

Due to a technical error, 286 clinical trials were excluded from the TGA’s internal tally of trials for which it has received notification over the four-year period.

The statistics have not yet been published on the TGA website but have been shared with some key industry stakeholders, the agency said.

The error occurred when the TGA switched to a new database for the trial data. A filter erroneously discounted trials if they were due to commence outside of the reporting period in which the TGA was notified about them.

Corrected figures show that 2432 trials were notified to the TGA between mid-2009 and end-2012, not 2146 as first thought. These statistics only relate to notifications - the TGA does not keep figures on how many trials commenced or were completed.

Biotechnology companies are required to notify the TGA of any clinical trials planned for Australia for unapproved therapeutic products or for products approved for one indication but being trialled in another.