Latest assessment metrics from the MHRA show that they assessed around 80 clinical trial applications (CTAs) per month during 2016. The number of applications for first in man studies ranged from 2 to 11 per month during last year, with the higher number reviewed in December. The MHRA present their average review times alongside their targets for assessment and processing; for phase I studies (excluding oncology patients) – within 30 days and an average of 14 days or less and for phase II-IV trials including phase I trials in oncology patients – initial assessment within 30 days. Only monthly averages are presented so it is impossible to say with certainty that the 30 day target was met for every application. However, the 14-day (for phase I excluding oncology patients) and 30-day (for phases II-IV including phase I trials in oncology patients) were met in all cases except for the month of August when the assessment and processing average time for phase I applications was 14.4 days.
The targets for issuing a decision letter for initial VHP national applications (monthly average of 10 calendar days from date of receipt) and for the assessment of substantial amendments (monthly average of 35 days) were met. Substantial amendments for phase I studies (excluding oncology patients) were reviewed in around 11 days compared with around 26 days for those for phase II-IV studies (including phase I trials in oncology patients).
These data confirm the MHRA as one of the leading regulatory agencies for assessing and processing CTAs, thereby supporting the conduct of clinical research in the UK.
To take a look at the data and that from previous years, please click here