What is a "Phase 1 Unit"?

[I_Love_Me_Vol.I]

I read about this in a BBC article on Hoodia, the San Bushmen appetite suppressant.

When the first human clinical trial was conducted, a morbidly obese group of people were placed in a “phase 1 unit”, a place as close to prison as it gets.

All the volunteers could do all day was read papers, watch television, and eat.

Half were given Hoodia, half placebo. Fifteen days later, the Hoodia group had reduced their calorie intake by 1000 a day.

It was a stunning success

My question has nothing to do with this clinical trial or with hoodia in general. I would just like to know what a “phase 1 unit” is. Specifically, units like the one referred to in this article.

Is it some sort of voluntary prison? A halfway house? Maybe some of the British dopers out there have heard of such a thing.

Thank you.

[Antigen]

Phase 1 clinical trials are generally a small group of people being given varying doses of the test drug in order to establish the safe dosage range, and spot any side effects. Because it’s the first time the drug is tested in humans, it’s usually very closely monitored, with the clinical trial setting resembling a comfy hospital. The one place I’ve seen that’s equipped for that sort of study has 24-hour nursing and medical staff on-site, and the patients are on heart monitors, blood pressure and temperature taken very often, and their blood and urine are tested regularly to see how the drug is being metabolized.

[I_Love_Me_Vol.I]

Ahh. OK. So “phase 1 unit” merely refers to the place that experimental subjects are kept while participating in certain types of experiments. And at least in the unit mentioned in the BBC article, the place is rather spartan.

I knew that sometimes people are kept in such conditions for experiments, but I thought the article was referring to a pre-existing place like a prison where the experimenters went to find a certain population.

I thought perhaps a phase 1 unit was a “fat-farm” or somesuch.

[cerberus]

Informed consent doctrines forbid the use of “volunteers” from populations incapable of giving informed consent. Institutionalised populations (whatever the institution) are generally not capable of voluntarily participating.

The prison comparison was used in the article to describe the degree of control employed in the experimental ward.

[cerberus]

Also note that Phase II and III Trials are the ones used to rigorously assess efficacy. Phase I trials assess metabolic profiles and safety issues. You’d need a Phase II/III sequence to show efficacy and safety under a range of dosage.