These measures of performance are intended to provide guidance to clinical trial sponsors on performance in terms of determination (acceptance, grounds for non-acceptance) for applications for clinical trial authorisations.
The charts will be updated monthly to present performance over the current business year (April to March). Historical data from implementation of the Clinical Trials Directive (1 May 2004) are also provided. As these data accumulate, the presentation will be on a five year rolling basis.
The data provided below details the number of applications assessed by MHRA, split by phase and commercial and non-commercial sponsors, with the exception of the GNA breakdown. Please note: the 2005 and 2006 data is only available as Phase I and Phase II/III/IV as the applications were not separated out any further at this time.
The phase of application correlates with the phases described in The Medicines (Products for Human Use) (Fees) Regulations and not the phase described by the applicant on their application form.
| 2012: UK clinical trial authorisation assessment performance |
|---|
Commercial Healthy Volunteer Trials (11Kb) |
| Non-commercial Healthy Volunteer Trials (11Kb) |
| Commercial Patient Trials (12Kb) |
| Non-commercial Patient Trials (12Kb) |
| All Phases - Commercial and Non-commercial (11Kb) |
| Outcome After First Assessment - Commercial and Non-commercial Trials (10Kb) |
| Breakdown of Review of GNA applications (57Kb) |
| Clinical Trials Notification Scheme metrics (13Kb) |
| Past years: UK clinical trial authorisation assessment performance |
|---|
| 2005 applications received by phase (12Kb) |
| 2006 applications received by phase (12Kb) |
| 2007 applications received by phase (13Kb) |
| 2008 applications received by phase (13Kb) |
| 2009 applications received by phase (13Kb) |
| 2010 applications received by phase (13Kb) |
| 2011 applications received by phase (11Kb) |
| Clinical trial applications received 2005 - 2010 (11Kb) |
