Bioequivalence and Bioavailability Forum • Data base corrupted?

Data base corrupted? [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2018-01-24 23:51 (2275 d 14:07 ago) – Posting: # 18290
Views: 8,124

Dear Ohlbe,

❝ Well... What would be the added value for a sponsor to spend time and resources to register in EudraCT a trial performed outside of the EU/EEA ?

I dug deeper and excavated trials with results:*
[image]

2010-021156-26 (USA), 2011-002949-35 (USA), 2011-003433-33 (USA), 2011-004901-25 (USA), 2012-000706-30 (USA), 2012-000728-17 (SGP), 2014-004350-34 (CAN), 2014-004767-21 (CAN), 2015-000466-57 (USA), 2015-000725-37 (USA), 2015-003005-41 (USA), 2015-003005-41 (USA), 2016-001896-63 (USA), 2016-004392-41 (CAN), 2016-004656-30 (CAN), 2016-004728-48 (USA), 2017-001803-57 (USA), 2017-002659-28 (USA), 2017-003956-22 (USA).

2015-001245-89 is funny (Fraxit?):
E.8.6.2 Trial being conducted completely outside of the EEA: No
E.8.6.3 Specify the countries outside of the EEA in which trial sites are planned: France
H.4.1 Third Country in which the trial was first authorised: France
2012-000855-15 performed in India but no results reported.

❝ ❝ ❝ ❝ #4: Zero?!

Trials with EudraCT protocols (outside the EU/EAA of total):
1,127 / 31,873 (all: 3.5% ≠ EU/EEA)
399 / 28,296 (adults: 1.4%)
152 / 21,932 (eldery: 0.7%)
611 / 11,023 (phase III: 5.5%)
158 / 18,866 (ongoing: 0.8%)
173 / 14,643 (completed: 1.2%)
152 / 1,667 (phase I: 9.1%)
25 / 150 (BE | comparative BA: 17%)
1,127 ≫ 0! Is this data base maintained at all? I call it an information sink.
Interesting the percentage of BE/BA studies outside the EU/EEA.

If I add the filter ‘Trial Status’ Completed zero (!) studies are returned.
Hint: If searching for an exact phrase, enclose the terms in typographic quotation marks (“foo bar”) or single quotes ('foo bar'). Double quotes ("foo bar") as delimiters don’t work.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

BE studies register in EU Beholder 2018-01-19 11:56 [Regulatives / Guidelines]
- BE studies register in EU Ohlbe 2018-01-19 12:01
  - BA studies register in EU Helmut 2018-01-19 12:32
  - BE studies register in EU Beholder 2018-01-19 13:10
    - BE studies register in EU nobody 2018-01-19 15:03
      - EU Clinical Trials Register: useless? Helmut 2018-01-22 15:47
        
        EU Clinical Trials Register: useless? nobody 2018-01-22 16:20
        
        these days only? Beholder 2018-01-23 08:09
        
        EU Clinical Trials Register: useless? Beholder 2018-01-23 08:15
        
        EU Clinical Trials Register: useless? Helmut 2018-01-23 13:02
        
        EU Clinical Trials Register: useless? Ohlbe 2018-01-23 17:54
        
        EU Clinical Trials Register: useless? Helmut 2018-01-23 17:57
        
        EU Clinical Trials Register: useless? Ohlbe 2018-01-24 11:48
        
        Studies outside the EU/EAA: Zero? Helmut 2018-01-24 12:12
        
        Studies outside the EU/EAA: Zero? ElMaestro 2018-01-24 13:15
        
        Data base corrupted?Helmut 2018-01-24 22:51