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amatewadi ☆ Pune, 2012-01-09 13:46 (5267 d 06:20 ago) Posting: # 7880 Views: 4,097 |
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Dear all, Can IEC give expedited approval for protocol in case "change in study design (crossover to parallel) on basis of previously approved and conducted study with increasing the sample size two times" ? Regards Prashant. |
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Ohlbe ★★★ France, 2012-01-09 16:54 (5267 d 03:13 ago) @ amatewadi Posting: # 7882 Views: 3,608 |
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Dear Prashant, ❝ Can IEC give expedited approval for protocol in case "change in study design (crossover to parallel) on basis of previously approved and conducted study with increasing the sample size two times" ? The only reference to expedited approval in ICH GCP is in § 3.3.5 on IRB/IEC SOPs: Providing, according to the applicable regulatory requirements, expedited review and approval/favourable opinion of minor change(s) in ongoing trials that have the approval/favourable opinion of the IRB/IEC. I would not consider a switch from cross-over to parallel and doubling the sampling size to be a "minor change"... And if it is for a new, unapproved trial, based on a previously conducted study, it won't be considered as an "ongoing trial" either. Regards Ohlbe — Regards Ohlbe |
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amatewadi ☆ Pune, 2012-01-11 06:31 (5265 d 13:36 ago) (edited on 2012-01-11 10:38) @ Ohlbe Posting: # 7895 Views: 3,451 |
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Ohlbe ★★★ France, 2012-01-11 11:40 (5265 d 08:27 ago) @ amatewadi Posting: # 7898 Views: 3,442 |
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Dear Prashant, If it is a new trial, it is not a change to an ongoing trial, and there is no provision in ICH GCP for expedited approval in such situations... Regards Ohlbe — Regards Ohlbe |
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Helmut ★★★   Vienna, Austria, 2012-01-09 17:22 (5267 d 02:45 ago) @ amatewadi Posting: # 7883 Views: 3,560 |
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Dear Prashant! ❝ […] on basis of previously […] conducted study with increasing the sample size two times"? Agree with Ohlbe’s post about the review. I hope you did not fall into the trap of “sample size in a parallel study = 2× of a cross-over”! This often quoted rule of thumb doesn’t work since a correlation between CVinter and CVintra doesn’t exist. From the cross-over study you already performed calculate CVtotal and base you sample size on it (see this post). — 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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drgunasakaran1 ★★  2012-01-13 18:51 (5263 d 01:16 ago) @ amatewadi Posting: # 7937 Views: 3,428 |
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Dear Mr.Prashant, Change in the study design and increase in the sample size will not be eligible for Ethics Committee's Expedited approval. Kindly be informed that as per the CDSCO's Minutes of the Meeting on matters relating to Global Clinical Trials Held On 17th October 2006 At IDMA Office - Mumbai, the following amendments require prior permission from DCGI along with Ethics committee full approval before implementation of the amendments. i) Change of Principal Investigator ii) Additional Patients to be recruited iii) Major changes in protocol with respect to study design, dose and treatment options For more details on the expedited review eligibility criteria for a study, check the following link Expedited Approval Criteria — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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amatewadi ☆ Pune, 2012-01-22 15:26 (5254 d 04:40 ago) @ drgunasakaran1 Posting: # 7987 Views: 3,294 |
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Thank you Sir. Regards, Prashant Nikam |
Ing. Helmut Schütz