Klinično preizkušanje novih vrst zdravljenja v onkologiji Clinical trials of new types of treatment in oncology

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Povzetek

V randomiziranih kliničnih raziskavah faze III (RKR), ki jih vse pogosteje sponzorirajo k dobičku naravnane farmacevtske družbe, raziskovalci primerjajo nova protirakava zdravljenja s standardnimi. Če se v RKR novo zdravljenje izkaže za učinkovitejše, je običajno odobreno za uporabo v vsakodnevni klinični praksi. V vlogi zdravstvenih strokovnjakov smo dolžni kritično vrednotiti nova zdravljenja in zahtevati preglednost njihovih prikazanih koristi. Z možnostjo dostopa do protokolov kliničnih raziskav, na podlagi katerih so nova zdravljenja odobrena za uporabo, in z nepristranskim poročanjem o njihovih škodljivih učinkih lahko dodatno izboljšamo preglednost prikazanih koristi novih protirakavih zdravljenj. Raziskovalci in sponzorji bi morali pogosteje opravljati posodobljene in sekundarne analize RKR, saj so lahko vir dodatnih pomembnih izsledkov.

Abstract (Eng)

In phase III randomised clinical trials (RCT), which are more and more often sponsored by profit-oriented pharmaceutical companies, the researchers compare the new anti-cancer treatments with the standard ones. If the new treatment proves to be more effective in the RCT, it is usually approved for use in daily clinical practice. As health care professionals, we are obliged to provide critical evaluations of new treatments and demand transparency of their benefits. The transparency of the indicated benefits of new anti-cancer treatments can be additionally improved by providing access to clinical research protocols, based on which the new treatments are approved for use, and impartial reports on their adverse effects. The researchers and sponsors should conduct updated and secondary analyses of RCT more often, as they might be a source of additional significant findings.