PHI 2396 Lecture Notes - Lecture 11: Phases Of Clinical Research, Randomized Controlled Trial, Clinical Trial

• School: University of Ottawa
• Department: Philosophy
• Course: PHI 2396
• Professor: Gervais Yamb Desire

Document Summary

Novel treatments typically undergo testing in human beings in phases i, ii and iii clinical trials before being adopted in clinical practice. Phase ii clinical trial: the treatment is given to a small group of patients to gather preliminary evidence of an effect on a disease. Phase iii randomized clinical trial: patients are allocated by chance to receive the novel treatment or the standard treatment (or placebo) and are followed for a period of time to document the outcomes (results) It is important to notice that the results of phase iii rcts form the basis of applications to license new drugs and provide evidence that may lead to changes in clinical practice (p. 183). The moral or ethical challenge: (cid:272)o(cid:374)fli(cid:272)t (cid:271)etwee(cid:374) the goals of (cid:373)edi(cid:272)al p(cid:396)a(cid:272)ti(cid:272)e (cid:894)(cid:271)est patie(cid:374)t"s (cid:373)edi(cid:272)al i(cid:374)te(cid:396)ests(cid:895) a(cid:374)d the goals of research (produce the best treatment). 1- equipoise and the ethics of clinical research according to benjamin freedman (pp.