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M.Vasu ★ India, 2009-03-24 05:16 (5895 d 01:35 ago) Posting: # 3394 Views: 6,965 |
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Hi, If the IRB disapproves clinical study, can the sponsor approach another IRB? Kindly coat with applicable guidelines?  Warm Regards!!!! VM - QA |
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ElMaestro ★★★ Denmark, 2009-03-24 19:19 (5894 d 11:32 ago) @ M.Vasu Posting: # 3401 Views: 5,644 |
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Hi M. Vasu, ❝ If the IRB disapproves clinical study, can the sponsor approach another IRB? Kindly coat with applicable guidelines? To be honest I don't know the answer to your question, so the following is a kind of common-sense-attempt... 1. I guess most of us have asked mum for an ice cream only to hear her say no, and then with success asking dad the same without mentioning that mum said no. Yummm! But the entire thing may backfire if or when mum and dad communicate. Good bye to ice creams for a bit of time in the future. 2. Imagine we ask dlabes' random number generator (in essence a good looking female of younger vintage) to roll a dice 20 times and sum the score of each roll. We want the sum to be at least 107. I bet the random number generator will not succeed in the first attemp. So we ask her to roll another 20. And she fails. And so forth. Stupid random number generator?? Well, sooner or later she will succeed, that's for sure. If your IRB saw something they didn't like then perhaps it's because there is a real problem or it could be that there is no problem and they are just a bunch of silly people. At any rate, regulators (at least in principle, in Europe) do want to know about it AFAIK when you apply for a clinical trial in case an IEC/IRB has given thumbs down (H3 on the form). So although you may not be breaking any laws -I have no idea if this is the case- I think it would be a step in the wrong direction to roll that dice again, and even though I am not a regulator I would think it could backfire on you if mum and dad start talking to each other. Come on, there must be others out there who have a much more qualified opinion about this interesting issue?! EM. |
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Helmut ★★★   Vienna, Austria, 2009-03-25 18:59 (5893 d 11:52 ago) @ ElMaestro Posting: # 3403 Views: 5,508 |
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Dear ElMaestro! First thank you very much for your example of childish and parental behaviour! Also your tractatus about random procedures was quite amusing. ❝ […] regulators (at least in principle, in Europe) do want to know about it AFAIK when you apply for a clinical trial in case an IEC/IRB has given thumbs down (H3 on the form). Just for people not familiar with EudraCT: Section H of the application form (which has to be used in all EU members states) deals with the Ethics Committee: H.3 Authorisation/opinion: [ ] H.3.1 to be requested [ ] H.3.2 pending [ ] H.3.3 given If given, specify: H.3.3.1 Date of authorisation / opinion: [ ] H.3.3.2 authorisation accepted / opinion favourable: [ ] H.3.3.3 not accepted / not favourable. If not acceptable / not favourable, give: H.3.3.3.1 - the reasons H.3.3.3.2 - the eventual anticipated date of resubmission:❝ So although you may not be breaking any laws […] OK, I will speak from an Austrian perspective (but generally similiar procedures will apply in other member states). GCP regulations (Directive 2001/20/EC and follow-ups) are implemented in national laws (in Austria it's the 'Medicines Law' - Arzneimittelgesetz / AMG). If the EC has objections (AMG §41a/b), the sponsor may modify the protocol by an 'Substantial Amendment'. If the sponsor does not modify the protocol or the EC still has objections, the competent regulatory authority has to enjoin the study within 60 days after the first submission (AMG §40/4). Theoretically the decision of the EC may be overulled (AMG §49) if the 'Advisory Board on Medicinal Products' - Arzneimittelbeirat (consisting of six expert members and optional additional experts) gives a positive vote. I wrote theoretically, because the Advisory Board deals only with the very tricky questions (e.g., gene therapy) - if your BE study was rejected by an EC chances are practically nil. ❝ Come on, there must be others out there who have a much more qualified opinion about this interesting issue?! I'm not qualified, but do know how to  — 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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Preet ☆ 2009-03-25 11:06 (5893 d 19:44 ago) @ M.Vasu Posting: # 3402 Views: 5,398 |
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Hi M. Vasu, It is highly impossible that any IRB/IEC disapproves clinical study without valid reason (safety concerns, efficacy etc.); even regulatory authorities (like US FDA, EMEA, ANVISA etc) won't follow this practice. If they are disapproving your clinical study, then they must provide valid reason for disapproval. In your case there can be two possibilities 1) IRB wants further information/clarification for its approval or 2) Simply disapproving your clinical study without reason. In first case: If they provide their views or they want corrections in the proposed clinical study (protocol), just incorporate this extra information, amend your clinical study protocol and resubmit for approval (to same IRB). In second case: If they are disapproving your clinical study without providing any reason, then you are having every right to approach another IRB. "The show must go on" Regards, Preet |
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LKN ● 2009-04-01 13:21 (5886 d 18:30 ago) @ M.Vasu Posting: # 3435 Views: 5,314 |
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Additionally in the European Commission "Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial" in the list of reuiqred documents under 1.5 stands Copy of ethics committee opinion in the MS concerned when available In this context you will be anyway expected to submit to the Regulatory Authority the negative opinion of the first EC as well. |
Ing. Helmut Schütz