Okl. So far I have performed an extense systematic review on a topic, I am convinced that there is enough evidence from both in vivo and in vitro evidence that suggests that a clinical trial would yield positive results. My question is related to how can I demonstrate there is enough evidence on to start a human trial and if that evidence can come from in vitro and in vivo research?
Hi,
Testing your work in clinic is always the graal!!
Maybe you could patent the hypotheses and supportive experimental work (if possible?). Then it is always easier to turn to an industrial partner to set up the clinical trial.
Another possibility is to discuss with a physician and try to convince them to set up the trial.
Good luck!
For NCT trials (number) in human is not simple , only if you are a Ph.D. MD.
Since you work in academia... your school has an IRB board that would need to approve the protocol. And you will also have to get pass the IRB in the hospital that would conduct the trial. I would ask someone there first. (Also... you should see how much funding you have for this...)
From your question... it seems that your human research would involve introducing something into the human subject.
There are several things that you will need to get done before that even happens. And most of these have to do with toxicity, both in vitro and in vivo. And you might need to do this in an acceptable animal. Basically, you have to demonstrate that what your are introducing has no endotoxin, is sterile, and poses no risk of toxicity/cytotoxicity. And depending on where you produce the material... you have to demonstrate that they are GMP compliant.
Having said that... if what you are introducing is oral...and is a nutraceutical, and there is extensive publications on using it in humans, you can skip all of that.
But by far the easiest for something completely new... is to partner up with an industry partner.
Shen-An Hwang Thank you very much for your reply. It was really helpful!
Camille Faure thank you for the info and the good wishes!!
Dear researcher,
Any research want to shift from invitro to invivo should have ethical approval first.
Then you have to do exvivo using animal model.You have to search about any work in animal .Now if you got the result and promising for human ,you will again start to write proposal to your college and get approval and then hospital approval after announcing for volunteer under medical professional supervision . Animal model result will help and support you for human trials.
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