Idea of Arun Arya trial, better than FDA now

There are 4 phases to a trial accepted by FDA

·         Phase I determines if a treatment is safe in humans (this is conducted in an ‘open label’ manner)

·         Phase II ‘double blindly’ assesses in a small cohort of subjects if the treatment is effective

·         Phase III involves randomly and blindly testing the treatment in a very large cohort of patients

·         Phase IV (often called Post Marketing Surveillance Trials) are studies conducted after the treatment has been approved for clinical use

In open label, the researchers and patients are known to each other and investigator. It is Phase II/III which is actively sabotaged by true patients since many are unhappy at secretly be chosen as guinea-pigs fed the ineffective placebo.

The Arya trial keeps the other phases intact, only modifies Phase II/III . Squeamishness of real patients is considered genuine and undermining of Phase II/III considered rational. A MUCH better approach is not to compare against ineffective but another best treatment at this time. Point is then there is no rational strategy and what you get is how much better this treatment is, over the past.

Only in rare cases a placebo be used. Only in cases of new vaccines does one truly need a placebo. Even in this case, one can subject one half to placebo and other to placebo then, and assume that trial was twice as big, and of half the duration!