Important innovations in ongoing trials include the development of multidomain interventions, and the use of biomarker or genetic inclusion criteria.
Such, current randomized colon clinical trials include the collection of tumor specimens for molecular assessment and multivariate analyses of prognostic and predictive factors.
Endovascular interventions currently in early human clinical trials include the use of lasers, ultrasonography, angioplasty, microsnares, and a variety of clot-retrieval devices.
Factors that are important in designing initial clinical trials include the proposed mechanisms of drug action, the ability and types of assays available to detect that activity or pharmacodynamic effect, and the extent of prior clinical experience.
The potential reasons for the disparity between research findings and clinical trials include the cell and tissue-specific actions of estrogens and the complexity of estrogen receptor regulation as well as limitations in clinical trial design.
Cohorts (target populations) for phase 2/3 trials include the general population of men over age 50 with a normal prostate-specific antigen (PSA), subjects with a strong family history of PCa, subjects with elevated PSA/negative biopsy, and subjects with HGPIN/negative biopsy.
