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Re: HerbieRay post# 104928

Monday, 04/24/2017 5:02:27 PM

Monday, April 24, 2017 5:02:27 PM

Post# of 423561
HB...

Quote: "Could this "unethicalness" come into play in Rit if the results are truly positive?"

There is a fair amount of misunderstanding regarding the subject of ethics when risk is involved...

Putting individuals in clinical trials at risk, including the risk of death, is not unethical. The rules are: individuals in clinical trials must be given informed consent (written with statements attesting they understand the risk)...Clinical studies can and do put people at risk for death or serious injury.

What is unethical is to withhold information from study subjects, or to put them at Unnecessary risk. Continuing a study with a single endpoint after clear and significant evidence might be unethical if continuing the study would not further medical or scientific knowledge.

A study might continue even if it shows high benefits if it is likely further medical or scientific evidence might be gleaned from continuing the study..There is no ethical issue if there is a reasonable possibility that continuing the study is in the best interest of medical science..

This I believe is the case In R=I. The secondary endpoints are in some cases important indications and if T2DM events are considered these SEs represent valuable medical information. All the SEs are fractions of the PE and might take more time to reach significance...

":>) JL
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