design protocol

[usr]

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hello

how can one desing a simple protocol to find and assess the benefits of a nutritional product for oncologic patients?

what you would do? any suggestions?

thanks

 

[Neuronix]

Randomize your target population to one group reciving your product and a second group receiving a product in the same packaging but that does not contain the active ingredient (placebo) but is otherwise identical. The packages should be numbered in such a way that a third party can track who gets what, but that neither the person evaluating for the effects of the treatment nor the patient can tell which group that patient belongs to.

Then follow the two groups with a validated measure of response, whether that's lab tests or surveys.

Step 1 is to design that process.
Step 2 is to get IRB approval for it.

 

[usr]

thanks

how should I determine the target population? same age, Ca stage/grade, other?

I am also in search of which lab or other tests and surveys to use to find evidence of product's efficacy, tolerability, etc, any ideas?

do I need any statistical analysis of the data?

thanks

 

[Neuronix]

how should I determine the target population? same age, Ca stage/grade, other?

That's up to you to decide.

I am also in search of which lab or other tests and surveys to use to find evidence of product's efficacy, tolerability, etc, any ideas?

Do you know the product you're studying? What do you expect it to do? Also you can read the literature to see what other people are using.

do I need any statistical analysis of the data?

Yes. Maybe you should find a mentor who performs clinical research?

 

[Neuronix]

Oh, and watch out for this guy: