However, this design treats the toxicity response as a binary indicator of dose limiting toxicity (DLT) and does not account for the number and specific grades of toxicities experienced by patients during the trial.
In almost all current Phase I designs, toxicity response is treated coarsely as a binary indicator of dose limiting toxicity (DLT) and a lot of useful toxicity information is discarded.
Chen et al. [1] proposed a novel normalized equivalent toxicity score (NETS) system to fully utilize multiple toxicities per patient instead of a binary indicator of dose limiting toxicity (DLT).
Two indicators of treatment dose were calculated.
The studies outlined above show that DCE-MRI biomarkers can provide early indicators of efficacy, dose and outcome.
As a result, the interpretation of BPDE-adducts as indicators of effective dose in studies of DNA methylation is not clear.
Development of biomarkers of exposure to PAHs and related compounds includes detection of protein and DNA adducts, which can be interpreted as indicators of effective dose [ 105].
Development of biomarkers of exposure and effects to PAHs and related compounds is now underway and includes measurement of urinary metabolites of specific PAHs as well as detection of protein and DNA adducts as indicators of effective dose.
Further, we will track patient participation with ATSA and (in the experimental arm) caregiver use of the Website and social support provided, allowing for indicators of intervention dose to be incorporated into our analyses.
Total cotinine and total NNAL, which are virtually unique to users of tobacco products and related materials, or people exposed to secondhand tobacco smoke, are excellent indicators of tobacco dose and are directly associated with lung cancer risk in smokers.
