Originally posted by Jim
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ChinaSCINet Update
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This is a sticky topic.
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F_P_F, I had the same thought but it is so- "Expanded access, sometimes called "compassionate use," is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA. FDA is committed to increasing awareness of and knowledge about its expanded access programs and the procedures for obtaining access to human investigational drugs (including biologics) and medical devices."
http://www.fda.gov/NewsEvents/Public...se/default.htm
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Originally posted by Jim View PostF_P_F, I had the same thought but it is so- "Expanded access, sometimes called "compassionate use," is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA. FDA is committed to increasing awareness of and knowledge about its expanded access programs and the procedures for obtaining access to human investigational drugs (including biologics) and medical devices."
http://www.fda.gov/NewsEvents/Public...se/default.htm
Safety- Ensuring patient safety is a priority - FDA must determine that the potential patient benefit justifies the potential risk of the expanded access use of the investigational drug, and that the potential risk is not unreasonable in the context of the disease or condition to be treated. Even with safeguards, there may be significant unknowns about safety and effectiveness.
- Patients should understand and be willing to accept the possible risks and unknown effectiveness associated with the investigational medical product. Patients generally will need to sign an informed consent form in order to receive the investigational drug.
- The patient’s physician must determine that the probable risk to the patient from the investigational drug is not greater than the probable risk from the disease or condition.
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- Ensuring patient safety is a priority - FDA must determine that the potential patient benefit justifies the potential risk of the expanded access use of the investigational drug, and that the potential risk is not unreasonable in the context of the disease or condition to be treated. Even with safeguards, there may be significant unknowns about safety and effectiveness.
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Originally posted by Jim View PostWe were told this would apply to our US IIb Trial, therefore it would have to be based on the safety data of the ChinaSCINet Phase II Trial.
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Originally posted by Fly_Pelican_Fly View PostOk. Will be interesting to see whether the FDA would accept the Chinese safety data. Would that be a US-first?
But I would also like to know if this would be a first, and if this will hold up either the trial or compassionate use.
Also Jim, didn't you say after 1 year has lapsed for IIb, that compassionate use applies? That would make sense as that might be enough of a safety window.
But, you then also said once the trial participants are chosen, that compassionate use will be available.
Keep up the Good work Dr Wise, Jim and everyone!
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Originally posted by Jim View PostActually, they didn't think to include sexual function as an outcome measure. When the subjects are examined for the 3 year follow-up they will ask.
BTW, sexual function is also controlled by a central pattern generator, so the chances of return are good.
While an inpatient at the Shepherd Center we were required to take classes that covered SCI sexuality. I would guess that most of the SCI speciality hospitals have the same.
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Originally posted by Barrington314mx View PostWhen you say "return", do you mean getting a hard-on without the use of say, Viagra for example? That probably doesn't include sensation but at least it'll be easier to keep the Mrs happy.
Lol anyway, cant wait for a response, especially on FDA approval for compassionate use. It's the weekend so maybe we'll get a reply in the weekday.
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Originally posted by Fly_Pelican_Fly View PostOk. Will be interesting to see whether the FDA would accept the Chinese safety data. Would that be a US-first?
Originally posted by taymas View PostGreat question - I never thought about this, but I also remember compassionate use being for those with life threatening problems (there have beeen good arguments here on CC that argue that SCI is life threatening) hence why some might qualify for compassionate use, with a relaxed attitude around safety - cos it's life threatening.
But I would also like to know if this would be a first, and if this will hold up either the trial or compassionate use.
Also Jim, didn't you say after 1 year has lapsed for IIb, that compassionate use applies? That would make sense as that might be enough of a safety window.
But, you then also said once the trial participants are chosen, that compassionate use will be available.
Keep up the Good work Dr Wise, Jim and everyone!
Originally posted by Barrington314mx View PostWhen you say "return", do you mean getting a hard-on without the use of say, Viagra for example? That probably doesn't include sensation but at least it'll be easier to keep the Mrs happy.
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Originally posted by Jim View PostI am totally speculating because we haven't yet interviewed the trial subjects, but because sexual function is programmed in the spinal cord (CPG) just like walking, bowel, and bladder, it would make sense that it may also return. Money is now being raised to bring the subjects back for complete examinations.
Have there been any sensory gains with this trial? Apologies if it was mentioned before.
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Originally posted by Scaper1 View PostGawd no. Not without return of function. Can you imagine still needing to cath and feeling everything?
Seriously I think these are the real things we need to know, not just for this trial but all of them.
No one really talks about the practicalities.
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