Topic: About clinical trial
I learn today that clinical trial ( such as phase 1,2 and 3 criteria etc.) was established in 1954. Wow, a kind of old standard,is it?
And as you all know,staring a couple years ago, ASCO promote the use of genomics as the standard starting point for oncology research . So how can we incorporate this new concept into the 1954 clinical trial old standard?
Are classic phase 1 or even early phase 2 trials obsolete?
In the current new drug development whereby molecular and efficacy profiles of the new drugs are much more accurate ( 50-70%) and well known before drug companies even select that chemical entity as a potential drug for new drug development. therefore is it necessary to have a large number of patients in a clinical trial rather than fewer patients. This is a challenge in patient selection in early phase clinical trial and will subject much less volunteers to harmful side effects.