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Beholder ★ Russia, 2018-01-19 12:56 (2648 d 23:33 ago) Posting: # 18222 Views: 10,318 |
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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 |
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Ohlbe ★★★ France, 2018-01-19 13:01 (2648 d 23:28 ago) @ Beholder Posting: # 18223 Views: 9,423 |
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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 |
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Helmut ★★★   Vienna, Austria, 2018-01-19 13:32 (2648 d 22:57 ago) @ Ohlbe Posting: # 18225 Views: 9,379 |
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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. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Beholder ★ Russia, 2018-01-19 14:10 (2648 d 22:19 ago) @ Ohlbe Posting: # 18226 Views: 9,422 |
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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 |
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nobody nothing 2018-01-19 16:03 (2648 d 20:26 ago) @ Beholder Posting: # 18228 Views: 9,378 |
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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 |
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Helmut ★★★ Vienna, Austria, 2018-01-22 16:47 (2645 d 19:42 ago) @ nobody Posting: # 18249 Views: 9,347 |
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Hi nobody, ❝ If people want to develop below the public radar, they go for non-EU clinics. With all this  about transparency I think that the wonderful EU Clinical Trials Register is a piece of pooh.  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. — 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 |
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nobody nothing 2018-01-22 17:20 (2645 d 19:09 ago) @ Helmut Posting: # 18250 Views: 9,207 |
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Really a surprise? Have a look at Diesel scandal how things work these days... — Kindest regards, nobody |
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Beholder ★ Russia, 2018-01-23 09:09 (2645 d 03:20 ago) @ nobody Posting: # 18255 Views: 9,175 |
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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 |
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Beholder ★ Russia, 2018-01-23 09:15 (2645 d 03:14 ago) @ Helmut Posting: # 18258 Views: 9,145 |
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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 |
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Helmut ★★★ Vienna, Austria, 2018-01-23 14:02 (2644 d 22:27 ago) @ Beholder Posting: # 18266 Views: 9,267 |
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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):
#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?! — 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 |
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Ohlbe ★★★ France, 2018-01-23 18:54 (2644 d 17:35 ago) @ Helmut Posting: # 18280 Views: 9,111 |
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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 |
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Helmut ★★★ Vienna, Austria, 2018-01-23 18:57 (2644 d 17:32 ago) @ Ohlbe Posting: # 18281 Views: 9,149 |
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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?! — 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 |
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Ohlbe ★★★ France, 2018-01-24 12:48 (2643 d 23:40 ago) @ Helmut Posting: # 18286 Views: 9,002 |
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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 |
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Helmut ★★★ Vienna, Austria, 2018-01-24 13:12 (2643 d 23:17 ago) @ Ohlbe Posting: # 18288 Views: 9,229 |
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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.  — 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 |
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ElMaestro ★★★ Denmark, 2018-01-24 14:15 (2643 d 22:14 ago) @ Helmut Posting: # 18289 Views: 9,184 |
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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.  — Pass or fail! ElMaestro |
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Helmut ★★★ Vienna, Austria, 2018-01-24 23:51 (2643 d 12:38 ago) @ Ohlbe Posting: # 18290 Views: 9,045 |
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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]](img/uploaded/image71.jpg) 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: NoE.8.6.3 Specify the countries outside of the EEA in which trial sites are planned: FranceH.4.1 Third Country in which the trial was first authorised: France2012-000855-15 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.
— 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 |
Ing. Helmut Schütz