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This may be so, but let's not forget that the discovery of surrogate markers of efficacy that could serve as alternative trial endpoints is the holy grail of clinical trials in humans.
In addition, the Program performs cutting-edge clinical trials that have identified potentially more effective treatments, as well as predictive and surrogate markers of efficacy that might help determine which patients will benefit from specific therapies.
Pilot clinical trials on the pharmacokinetics and mechanism-based markers of efficacy of the selected intervention should precede phase I III development in suitable populations.
Biomarkers as predictive and prognostic markers of efficacy are still under investigation in an attempt to guide treatment selection in patients with advanced melanoma, and additional studies are needed to provide guidance for selection of checkpoint inhibitors to be used in sequence or combination.
Surrogate markers of efficacy could be the detection of antigen spreading i.e. the identification of tumor specific CTL recognizing epitopes that were not present in the initial vaccine [28], [29], suggesting that alternate effectors elicited by the vaccine could mediate tumor destruction and subsequent CTL responses [30].
In addition to survival, weight loss and clinical scores were used as other markers of efficacy.
Similar(43)
Lupus pernio is a skin manifestation of sarcoidosis that does not remit spontaneously, and was used as a marker of efficacy of thalidomide for sarcoidosis.
The measurement of HBV DNA levels has become the most direct and reliable method used for accurate diagnosis and prognosis of acute and chronic HBV infection [Mommeja-Marin R, Mondou E, Blum MR, Rousseau F. Serum HBV DNA as a marker of efficacy during therapy for chronic HBV infection: analysis and review of the literature. Hepatology 2003 37:1309–19].
The authors proposed an interesting marker of efficacy for radiologic IU as the highest ratio of "eyes-to-image" versus "eyes-to-interface" device time.
However, there is a limitation of Kt/V as a marker of efficacy for this treatment method.
Monitoring p21 waf1, cip1 activation rather than the more generic histone acetylation may be a more predictive marker of efficacy.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com