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amatewadi ☆ Pune, 2012-02-23 08:43 (5239 d 05:37 ago) Posting: # 8160 Views: 3,742 |
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Dear All, In case of Informed Consent form for single dose Bio-equivalence study, under section "Possible Side effects/ Adverse events", should we explaine all available information about undesirable effects from product monograph or the effects which are related to only single dose? |
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drgunasakaran1 ★★  2012-02-23 09:21 (5239 d 04:59 ago) @ amatewadi Posting: # 8161 Views: 3,285 |
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Dear Mr.Amatewadi, It is highly recommended to include all the adverse events in the ICF even though they were observed in the Clinical Trials as mentioned in the product monograph. If you mention only the most common adverse events in the ICF, the Ethics committee may raise concern that you are not revealing all possible side effects to the study participants. — 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, 2012-02-23 11:13 (5239 d 03:08 ago) @ drgunasakaran1 Posting: # 8164 Views: 3,199 |
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❝ It is highly recommended to include all the adverse events in the ICF even though they were observed in the Clinical Trials as mentioned in the product monograph. If you mention only the most common adverse events in the ICF, the Ethics committee may raise concern that you are not revealing all possible side effects to the study participants. Dear Sir, Thanks for your kind reply. As per FDA guidance "A Guide to Informed Consent - Information Sheet Guidance for Institutional Review Boards and Clinical Investigators Contents" http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm "The risks of procedures relating solely to research should be explained in the consent document. The risks of the tests required in the study protocol should be explained, especially for tests that carry significant risk of morbidity/mortality themselves. The explanation of risks should be reasonable and should not minimize reported adverse effects. The explanation of risks of the test article should be based upon information presented in documents such as the protocol and/or investigator's brochure, package labeling, and previous research study reports. For IND studies, the IRB should assure that the clinical investigator submits the investigator's brochure (when one exists) with the other study materials for review." it means that the risk involved only after single dose shall be included. does it? Regards, Prashant Nikam |
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drgunasakaran1 ★★ 2012-02-24 06:53 (5238 d 07:28 ago) @ amatewadi Posting: # 8167 Views: 3,165 |
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❝ "The risks of procedures relating solely to research should be explained in the consent document. The procedures stated here corresponds to any procedures relating solely to research (e.g., randomization, placebo control, additional tests ) See Para 3, Section 21 CFR 50.25 Elements of informed consent ❝ The explanation of risks of the test article should be based upon information presented in documents such as the protocol and/or investigator's brochure, package labeling, and previous research study reports. The above statement implies that we need to provide all possible risks involved with test article eg., adverse events based on information from protocol, IB, PIL, previous study reports. ❝ it means that the risk involved only after single dose shall be included. does it? No. We need to provide all possible side effects. The adverse events profile related to single dose administration will not be usually available in the public domain and practically it is not feasible to include only the adverse events occurred in the single dose studies. — 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, 2012-02-24 08:53 (5238 d 05:27 ago) (edited on 2012-02-24 10:00) @ drgunasakaran1 Posting: # 8168 Views: 3,153 |
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It is important to give straightforward facts. It is very doubtful that many volunteers could begin to understand this section. as What is being listed is the SmPC/ protocol/ IB/ PIL information for physicians, not an appraisal of what a volunteer should know about the side effects of a single dose. as long-term AEs will NOT be seen. So, the ICF needs to inform volunteers about what could happen (simply) in single dose given to them. Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] |
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Ohlbe ★★★ France, 2012-02-24 11:36 (5238 d 02:45 ago) @ amatewadi Posting: # 8169 Views: 3,143 |
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Dear Amatewadi and Gunasakaran, In a way I think you both are right... It is true that there will be very little published information on adverse events that can be expected after a single dose. Anyway what was observed in Phase I trials with the originator will only be the most frequent AEs (there was a limited number of subjects treated). If one adverse event described during long-term treatment was not seen in Phase I trials, it does not mean that it cannot happen after a single dose: it may be that there were not enough subjects treated to get a chance to see it. So you have to take into consideration all AEs described with the product. On the other hand the section on risks in the ICF needs to remain readable for the subjects. First, this implies to use simple words (no subject will know what Stevens-Johnson Syndrome is, for instance). And all information in the Investigator's Brochure may not need to be carried forward into the ICF. One possible solution is to refer to the package insert / product leaflet / whatever name you give to that sheet of paper intended for the patient which you will find inside the box of the originator product, and put in the ICF the AEs described in that document. Regards Ohlbe — Regards Ohlbe |
Ing. Helmut Schütz