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Showing posts with label Double Blind Placebo Controlled Controlled Study of Adjuvant MEDI4736 In Completely Resected NSCLC. Show all posts
Showing posts with label Double Blind Placebo Controlled Controlled Study of Adjuvant MEDI4736 In Completely Resected NSCLC. Show all posts

Double-blind, Placebo-controlled Study

The best and most reliable form of research is the double-blind, placebo-controlled study. A treatment cannot really be said to be proven effective unless it has been examined in properly designed and sufficiently large studies of this type.


In these experiments, one group of subjects receives the "real thing"—the active substance being tested. The other half receives a placebo designed to appear, as much as possible, like the real thing. Individuals in both groups don't know whether they are getting the real treatment or placebo (they are "blind"). Furthermore, the researchers administering placebo and real treatment are also kept in the dark about which group is receiving which treatment (making it a "double-blind" experiment). This last part is important, because it prevents the researchers from unintentionally tipping off the study participants, or unconsciously biasing their evaluation of the results.


The purpose of this kind of study is to eliminate the power of suggestion. It is true, although hard to believe, that people given placebo (fake) treatment frequently report dramatic and long-lasting improvements in their symptoms. However, if the people in the real treatment group fare significantly better than those in the placebo group, it is a strong indication that the treatment really works.


What you've just read is a highly simplified introduction to a crucial and non-intuitive topic. If you'd like a more in-depth analysis, see the article Why Does This Database Rely on Double-blind Studies?


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Double Blind Placebo Controlled Controlled Study of Adjuvant MEDI4736 In Completely Resected NSCLC

Further study details as provided by Canadian Cancer Trials Group:


Primary Outcome Measures:
    Compare Disease free survival (DFS) for patients with NSCLC that is PD-L1 positive [ Time Frame: 5.5 years ]

Secondary Outcome Measures:
    Compare Disease Free Survival in all randomized patients [ Time Frame: 7 years ]

Compare overall survival (OS) for patients with NSCLC that is PD-L1 positive [ Time Frame: 5.5 years ]


Compare overall survival for all randomized patients [ Time Frame: 7 years ]


Compare Lung cancer specific survival for patients with NSCLC that is PD-L1 positive and all randomized patients [ Time Frame: 7 years ]


Evaluate the nature, severity and frequency of adverse effects and tolerability of MEDI4736 [ Time Frame: every 6 months ]


All patients who receive at least one dose of MEDI4376/placebo will be included in the safety analysis. Descriptive summary tables will be presented on safety parameters by treatment arm. There will be safety monitoring by the NCIC CTG Data Safety Monitoring Committee (DSMC) every 6 months


Evaluate the Quality of life between the two treatment arms in PD-L1+ patients and in all randomized patients. [ Time Frame: 5.5 years ]


The quality of life (QoL) of patients will be assessed using EORTC QLQ-C30 and the lung cancer module (QLQ-LC13) incorporated.


Determine survival benefits participants judge necessary to make adjuvant immunotherapy worthwhile [ Time Frame: 5.5 years ]


Determine the incremental cost effectiveness and cost utility ratios for MEDI4736 [ Time Frame: 5.5 years ]


Evaluate the predictive/prognostic significance of PD-L1 expression [ Time Frame: 5.5 years ]


Evaluation of changes in plasma/serum cytokines and other blood and tissue based biomarkers after treatment with MEDI4736 and at disease event [ Time Frame: 5.5 years ]


Explore polymorphisms that may be associated with outcomes [ Time Frame: Baseline only ]