The current non-clinical testing strategy includes in vitro IKr current assessment in heterologous mammalian cell lines expressing the human ether-a-go-go-related gene (hERG, Kv11.1) channels, which have been agreed to play a crucial role in human cardiac electrophysiology.
Novel pre-clinical testing strategies are required to identify, at an earlier stage in the development pathway, chemicals and drugs that are likely to provoke toxicity in humans.
Tsiplova K, Zur RM, Marshall CR et al. A microcosting and cost-consequence analysis of clinical genomic testing strategies in autism spectrum disorder.
ACCORD was a clinical trial testing strategies for glycemic control and a variety of medications were available for use to obtain the target A1Cs in each arm of the trial.
The authors concluded that a clinical risk-based testing strategy, even if implemented successfully in their facility, would still have missed an earlier diagnosis the majority of the time.
Both the past and present early clinical trial efforts to test these clinical trial strategies are described.
This paper will provide a general overview of the history of perimetry, selection of stimulus parameters, development of test strategies, clinical testing conditions, new procedures and approaches to perimetry, experimental design, analysis and interpretation methods, hypothesis testing, prediction and forecasting procedures, and other related topics.
The C difficile polymerase chain reaction (PCR) cycle threshold (CT) can sensitively predict the presence of free C difficile toxins; however, the clinical application for this testing strategy remains unexplored.
Which aspects of the pharmacogenomic testing strategy reflect clinical utility/benefit above current practice (eg, improved clinical validity, less invasive testing).
Several challenges remain before clinical testing of these therapeutic strategies can be considered.
