Data base corrupted? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-01-24 23:51 (2340 d 01:00 ago) – Posting: # 18290
Views: 8,301

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:*
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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. :PCchaos:
Interesting the percentage of BE/BA studies outside the EU/EEA.



Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
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