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 The Study set forth two objectives:
 (I) provide the drug (marijuana/THC) on a
 compassionate basis to seriously ill persons not responding to
 conventional treatments and
 (2) mfacilitate clinical trials of Cannabis and its
 derivatives N in some patients pursuant to the federal !ND
 procedtlres. 2_/
 Xn order _to accomplish these two potentially
 conflicting objectivese the Panel planned a large collaborative
 Phase IIi trial. _ As noted by the Panei_ 2_// a large=
 population Phase Ill study means basic toxicology and
 pharmacology tests_ Phase I animal testing and Phase II
 evaluation of the drug within normal and small population patient
 267/ I d. The Panel indicated the meaning of a Phase IIi
 program as follows:
 Among the safeguards for developing an
 investigational new drug is a step-wise
 testing process: the drug is tested in
 animals before humans, in normal volunteers
 before patients_ and in small _roups of
 people before large groups. Preclinical
 refers to non-human experiments_ e.g.
 toxicity and pharmacology experiments in
 animals. _e i is conducted in small
 numbers of normal human volunteers to
 determine dosage levels and o_ler pharma-
 cologic parameters° _ clinical trials
 typically involve small numbers of patients
 and comparisons to other treatment° £hase
 /J_ is to confirm effectiveness and to assess
 adverse effects in a large and diverse
 patient population. P/I_____ is used to
 ...... describe post_marketing reporting on drug
 safety and effectiveness. _.
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