All Times EDT
Keywords: Clinical trials, Variability, Bioequivalence, Study design, Sample size, Pharmacogenetics
Statistics has been an indispensable tool for succeeding in the experimental setting in pharmacology. Moreover, for trials with bioequivalence and comparative bioavailability purposes, where crossover designs are common and feasible to be performed, the blockage of potential sources of variation leads to a reduction of the expected biological variability in the pharmacokinetic parameters. Prospective views on this research line are to study the phenotype-genotype relationship with the information retrieved in controlled trials, to link genetic polymorphisms with pharmacokinetic phenotypes of specific drugs.
In this roundtable, the participants will be able to share and feedback in-house experiences on the conduction of pharmacokinetics (PK), bioequivalence, and biosimilarity clinical trials in different populations, pointing out the repercussion of the sources of variation to be controlled in a clinical experimental setting, with drugs in several therapeutic areas, done not only in classical crossover 2x2 formats but also in parallel, replicated and two-stage sequential designs. Regarding the biological PK variability (within-subject and between-subject), it is a key aspect for the trial design and sample size calculation. So, this interaction will reinforce the need for high-quality pharmacological information and the importance of its correct statistical analysis, to provide backup information for further trial design on the same active principles and pharmaceutical forms.
The overall intention of this roundtable will be to emphasize how the clinical and statistical design elements mentioned above can impact the field of Clinical Research. This allows a substantial reduction in time and costs, as well as lower sample sizes, which minimizes the exposition of healthy volunteers to unneeded pharmacological treatments and speeds up the development and positioning of generic drugs into the market, which ultimately has social and economic impacts.