Beholder
★    

Russia,
2018-01-19 12:56
(2374 d 00:44 ago)

Posting: # 18222
Views: 9,462
 

 BE studies register in EU [Regulatives / Guidelines]

Hello!

In RF we have register of approved BE studies published in internet. Does sb know any EU register for BE studies performed/being performed in EU or the registers are on national levels of Member states of EU? I have found this but the site is for clinical trial, not BE.

Thanks in advance

Best regards
Beholder
Ohlbe
★★★

France,
2018-01-19 13:01
(2374 d 00:38 ago)

@ Beholder
Posting: # 18223
Views: 8,687
 

 BE studies register in EU

Dear Beholder,

❝ I have found this but the site is for clinical trial, not BE.


Well, BE trials are clinical trials, aren't they ? If you type "bioequivalence" you'll get 55 hits, so at least "a number" of them have been entered.

What you will not find is trials with a clinical part out of the EU, but the bioanalytical part in the EU. I know several European bioanalytical labs which work with non-EU clinics.

Regards
Ohlbe
Helmut
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2018-01-19 13:32
(2374 d 00:08 ago)

@ Ohlbe
Posting: # 18225
Views: 8,653
 

 BA studies register in EU

Hi Ohlbe & Beholder,

❝ Well, BE trials are clinical trials, aren't they ? If you type "bioequivalence" you'll get 55 hits, so at least "a number" of them have been entered.


I suggest to try “bioavailability” as well. Strictly speaking BE is the desired result of a comparative BA study. Therefore, some protocols don’t contain BE in the title. Of course, only a part of the 150 studies assess BE. There is no free lunch.

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Beholder
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Russia,
2018-01-19 14:10
(2373 d 23:29 ago)

@ Ohlbe
Posting: # 18226
Views: 8,666
 

 BE studies register in EU

Dear Ohlbe,

❝ Well, BE trials are clinical trials, aren't they ? If you type "bioequivalence" you'll get 55 hits, so at least "a number" of them have been entered.


Ok, they are clinical trials as well. However there is such point that BE studies are smth special and more connected with testing than with real clinical trial where amount of really new information is quite big.

Hm. 55 hits...In RF register I found approximately 900 finished BE studies starting from 2010 when register was firstly created. ok, companies in RF must perform studies exactly in RF but I find 55 hits - quite small amount for Union with 500 mln people. Or almost all clinical parts of BE studies are performed outside EU so we dont see them?

Best regards
Beholder
nobody
nothing

2018-01-19 16:03
(2373 d 21:37 ago)

@ Beholder
Posting: # 18228
Views: 8,636
 

 BE studies register in EU

If people want to develop below the public radar, they go for non-EU clinics. But look at clintrials.gov and the fines they (in principle) have for non-compliance with filing rules. Never charged anybody for non-compliance from first day up to now. Won't change.

Kindest regards, nobody
Helmut
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2018-01-22 16:47
(2370 d 20:52 ago)

@ nobody
Posting: # 18249
Views: 8,589
 

 EU Clinical Trials Register: useless?

Hi nobody,

❝ If people want to develop below the public radar, they go for non-EU clinics.


With all this :blahblah: about transparency I think that the wonderful EU Clinical Trials Register is a piece of pooh. :not really:
I can’t find a single one [sic] of my studies. Searched by the formulation, API, sponsor, EudraCT number, protocol number, study title, and a lot more. All studies performed in Germany, the bloody XML-files (including results) submitted to the BfArM and via the awful web-interface to EudraCT.

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nobody
nothing

2018-01-22 17:20
(2370 d 20:19 ago)

@ Helmut
Posting: # 18250
Views: 8,488
 

 EU Clinical Trials Register: useless?

Really a surprise? Have a look at Diesel scandal how things work these days...

Kindest regards, nobody
Beholder
★    

Russia,
2018-01-23 09:09
(2370 d 04:31 ago)

@ nobody
Posting: # 18255
Views: 8,435
 

 these days only?

Hi nobody!

❝ Really a surprise? Have a look at Diesel scandal how things work these days...


What about lead contaminating more than 50 years ago?

Best regards
Beholder
Beholder
★    

Russia,
2018-01-23 09:15
(2370 d 04:24 ago)

@ Helmut
Posting: # 18258
Views: 8,418
 

 EU Clinical Trials Register: useless?

Hi Helmut,

❝ ... the bloody XML-files (including results) submitted to the BfArM and via the awful web-interface to EudraCT.


Saying XML-files, do you mean the special XML "cover" which is used for EU submission (registration dossier)? If so than do you use special software to convert simple pdf to "magic" XML? Im asking because in EEU we are going to use similar approach which I described above.

Best regards
Beholder
Helmut
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2018-01-23 14:02
(2369 d 23:37 ago)

@ Beholder
Posting: # 18266
Views: 8,522
 

 EU Clinical Trials Register: useless?

Hi Beholder,

❝ Saying XML-files, do you mean the special XML "cover" which is used for EU submission (registration dossier)? If so than do you use special software to convert simple pdf to "magic" XML?


Nope. In order to obtain an EudraCT number the sponsor has to create an account / register at the European Clinical Trials Database. The EudraCT number and a completed “Request for Authorisation of a Clinical Trial on a Medicinal Product for Human Use to the Competent Authorities and for Opinion of the Ethics Committees in the Community” is required when submitting the protocol to the EMA (CP) or the chosen reference member state (DCP). From the XML a PDF can be created. What is bizarre: The PDF cannot be electronically signed (a signature is required in Section I.3.2). Hence, one has to print it out, sign it, scan the page, …
Once the study is completed, results have to be provided by the same wacky web-interface.

BTW, interesting the EudraCT Statistics as of December 2017 (renumbered):
  1. Number of Clinical Trials recorded in the EudraCT Database: 52,586
  2. Total number of Clinical Trial Applications recorded by Member State, Competent Authorities in the EudraCT Database: 117,198
  3. Total number of Clinical Trial Site Inspections: 6,734
  4. Total number of EudraCT Numbers requested in response to the question: “Is it anticipated that this EudraCT Number will be used for a Clinical Trial conducted in a third country (outside of the EU/EEA)?”: 0
#2 is higher than #1 since “a clinical trial may involve several Member States. Each Member State creates a record; therefore several records may exist for one clinical trial representing each of the Member States involved. The total given here represents the number of individual Member State records of clinical trials and is therefore higher than the number of separate trials provided under #1 above.”
#3: 12.8% of studies were inspected? Wow! Given that some studies with an assigned EudraCT number were never performed, the percentage is higher.
#4: Zero?!

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Ohlbe
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France,
2018-01-23 18:54
(2369 d 18:46 ago)

@ Helmut
Posting: # 18280
Views: 8,376
 

 EU Clinical Trials Register: useless?

Dear Helmut,

❝ #3: 12.8% of studies were inspected? Wow! Given that some studies with an assigned EudraCT number were never performed, the percentage is higher.


No. In a Phase 3 study they may have inspected several clinical sites, the sponsor, a central lab, a CRO... And several Member States may inspect the same trial. So I would expect the figure to be much lower.

Regards
Ohlbe
Helmut
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Vienna, Austria,
2018-01-23 18:57
(2369 d 18:43 ago)

@ Ohlbe
Posting: # 18281
Views: 8,388
 

 EU Clinical Trials Register: useless?

Dear Ohlbe,

❝ ❝ #3: 12.8% of studies were inspected? Wow! […]



❝ No. […] I would expect the figure to be much lower.


All too bad!

Any ideas about:

❝ ❝ #4: Zero?!


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Ohlbe
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France,
2018-01-24 12:48
(2369 d 00:51 ago)

@ Helmut
Posting: # 18286
Views: 8,270
 

 EU Clinical Trials Register: useless?

Dear Helmut,

❝ Any ideas about:

❝ ❝ ❝ #4: Zero?!


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 ?

Regards
Ohlbe
Helmut
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Vienna, Austria,
2018-01-24 13:12
(2369 d 00:28 ago)

@ Ohlbe
Posting: # 18288
Views: 8,493
 

 Studies outside the EU/EAA: Zero?

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 ?


Transparency/honesty? The only study outside of the EU/EAA I was involved in was registered with EudraCT 2009-013059-31.
Don’t search the data base. As I wrote above I couldn’t find it. :confused:

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ElMaestro
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Denmark,
2018-01-24 14:15
(2368 d 23:24 ago)

@ Helmut
Posting: # 18289
Views: 8,454
 

 Studies outside the EU/EAA: Zero?

Gentlemen,

I see you are having a nice theoretical discussion. Feel free to trespass a little into real life: It is important to look good and sounding like you are doing the right thing in the public domain. Doing something useful, doing something right, is absolutely old-fashioned and an complete irrelevant activity nowadays. Especially if it has negative implications for the budget. I am not even blaming it on LEAN this time.

Oh, do I sound like a grumpy old geezer now? That wasn't intended at all. :crying:

Pass or fail!
ElMaestro
Helmut
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Vienna, Austria,
2018-01-24 23:51
(2368 d 13:49 ago)

@ Ohlbe
Posting: # 18290
Views: 8,317
 

 Data base corrupted?

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.


  • 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.

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