Module 9 2021

22/03/2021

ONCOLOGY: IMPACT OF PERSONALIZED MEDICINE

Tx E

Che mo X

Tx D

CHEMO X Pool of trial pts

Tx C

Tx A

Tx B

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CHALLENGES AS TREATMENTS MAY HAVE MOVED ON, WHICH IS PARTICULARLY THE CASE IN ONCOLOGY.

New therapies may have been added to standard treatment regimens and may drown out the effect of the test medication Exact effect of the test product in the new chemotherapy regimen will not be known. Target population may decline or change as treatments become more and more personalized. Thus even now it is becoming less and less feasible to conduct an appropriately designed equivalence trials in some indications ; in the future this will only get worse, Yet unless biosimilars can be developed, treatment costs will continue to spiral unabated.

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