Focus Here for LDN trial

[Guest guest]

This is where we need to focus

http://nccam.nih.gov/about/plans/2005/index.htm

--- In low dose naltrexone , " lv2puttz " <Lv2puttz@c...>

wrote:

> > Is there any chance to find a medical professional or

institution

> > that might take interest in pursuing an Investigator

Initiated

> > Trial for LDN?

>

> I hear that there is alot of monies involved, Infact I recently

read

> this below on the Goat serum trial site

> -------------------------------------------------------------------

---

>

> The three phases of clinical development

>

> Clinical Phase I involves studies performed on a small group of

> healthy volunteers. The purpose initially is to study how the new

> product is metabolised in the human body, and then to determine

the

> dose and dosage interval that will have a positive effect on the

> disease without causing unwanted side-effects.

>

> Clinical Phase II involves treating a larger group of patients

> (usually 50-200). The purpose is to demonstrate the drug's

efficacy

> and to confirm its safety. Comparisons are often made with a group

> receiving inactive placebo treatment.

>

> Clinical Phase III is sometimes referred to as confirmation

studies.

> The main goal is to prove that the promising effects seen in Phase

II

> are also obtained in larger patient groups (usually 100-1,000

> people). At Phase III, great importance is also attached to safety

> issues, documentation and production preparations.

>

> SEK 500 - 700 million for a successful project

> The costs involved in the clinical development of a new drug are

> somewhere in the region of SEK 500-700 million for a successful

> project.

> The average development time is six to seven years from the first

> human trials. This includes the time required for reporting and

for

> the compilation of the documentation necessary to obtain the

> permission of the authorities to proceed from one phase to the

next.

> The probability that a project that has reached clinical Phase I

will

> reach the market is on average around 20 per cent. This means that

a

> maximum of one in five projects is successful. For projects that

> reach Phase II, the probability of success is higher, or around 30

> per cent, and rises to around 70 per cent in Phase III.

>

> Clinical Phase I Clinical Phase II Clinical Phase III

> 1-1.5 years 1.5-2.5 years 2-4 years

> SEK 50-75 million SEK 100-200 million SEK 250-500 million

>

> The sale of a product that successfully reaches the market has to

> cover not only its own development costs, but also the costs

involved

> in projects that are not successful. A pharmaceutical's total

> development costs can thus be estimated to total SEK five to ten

> billion.