Clinical Trial Stages4 Jun 2018 10:03
Rather than having meaningless debates abt sp, how abt a little factual info- no doubt unappreciated by the rampers / those disproving of my presence (lol) here just b/c I disagree with double figure and esp �25 claims, but hey ho!!
A few of you, including Wideyed asked me directly (sorry I overlooked it on Fri!), queried why FARN�s drug passed CT 1 and 2 yet failed CT3. Before I answer that it wld be useful to know the following if investing in **any** pharma company imho:
*Phase 0: Concerned with measuring the pharmokinetics (effects of body on the drug) & pharmacodynamics (effects of drug on body). Measure �absorption, distribution, metabolisation�.
10-15 people only thus not very accurate
*Phase 1: Primary objective to test for safety and dosage mainly, and any side effects though not all may manifest themselves at this stage nor are they expected to.
Normally involves 20-100 people
*Phase 2: Primary objective to determine(any) efficacy of the drug and further test the safety where less common side effects can be investigated ; often tested against a placebo
Normally involves 100-300 people
*Phase 3: Primary objectives to *confirm* efficacy, safety *and* evaluate effectiveness. Often compared with existing treatments (if any). Side effects which have been established in CT1 & 2 are monitored at this level.
Normally involves 1000-3000 people
*Phase 4: Post marketing surveillance measuring safety e.g risks, benefits and optima application. Ongoing throughout the lifetime of a drug following appt. approval eg FDA/ EMA etc.