Data base corrupted? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-01-24 23:51 (2723 d 06:21 ago) – Posting: # 18290
Views: 9,269

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



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

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

Complete thread:

UA Flag
Activity
 Admin contact
23,428 posts in 4,929 threads, 1,686 registered users;
64 visitors (0 registered, 64 guests [including 20 identified bots]).
Forum time: 07:12 CEST (Europe/Vienna)

To know that we know what we know,
and to know that we do not know what we do not know,
that is true knowledge.    Nicolaus Copernicus

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5