Dermatology

Dermatology

An example of a brilliant risk management of the project together with the right site selection and speed up of enrollment to reach the planned targets in time.

A Multicentre, Randomised, Double-Blind, Parallel-Group Study of the Efficacy and Safety of generic topical treatment versus vehicle and original product in the Treatment of Mild to Severe Plaque-Type Psoriasis

3 arm study, up to 651 subjects in total

Originally study planned in 4 countries, half of the expected enrollment predicted from Russia (approx. 350 subjects)

Country Sites Subjects/Site
 Czech Republic (CZ) 18 12
 Slovakia (SK) 8 10
 Germany (GER) 1 15
 Russia (RU) 5 70

 

 Originally Planned study timelines
 First submission to Regulatory Authorities’s  (RA), Ethics Committees’s: ( EC):  Dec 2010
 First approval from RA’s, EC’s:  Feb/Mar 2011
 First Subject In:  Mar 2011
 Last Subject In:  Oct 2011
 Last Subject Out:  Dec 2011
 Lock of Database:  Mar 2012
 Study Final Report:  Apr 2012 – fixed date, booked registration  slot of Sponsor

 

Study Development:

Study has been approved by EC and competent authority (CA) one month later than scheduled ( in Jan 2011)  and the First Patient First Visit  FPFV have been enrolled in the Czech Republic and Slovakia in May 2011 due to multiple reasons (insurance policy, contract negotiation). The major issue occurred in Russia, where local CA requested pre-clinical data, which were not available due to generic nature of the product.

As a back-up country to replace Russian portion of planned patients were selected Ukraine and Bulgaria. In parallel feasibility of additional Czech sites has been started.
Ukraine has not been opened finally due to complicated process of insurance, which was not in line with Sponsor’s rules. Bulgaria also not opened due to longer approval period, which would not allow timely enrollment of subjects.

Decision has been taken to proceed only with Czech Republic and open more sites there.

New sites started to be added in Sept 2011. The enrollment was supported by very close site management and communication with investigators.

The enrollment has been finished in planned time, last subject in was in Jan 2012.

Final report to the client delivered in Apr 2012 in line with the original plan.

Product has been successfully registered based on this study results.
 

Subject accrual in Aug 2011
191 subjects Sites: EU (CZ  - 18, SK - 5, GER - 1)  

Subjects accrual in Sept 2011
291 subjects  Sites: EU (CZ  - 24, SK - 5, GER - 1)

 

Subjects accrual Dec 2011
653 subjects Sites: EU (CZ  - 34, SK - 5, GER - 1) 

 

Average Number of Randomized Subjects per site per month
CZ 3,4
SK 1
GER 0,3