SOLUTIONS
For a better translation from study design to trial success.
Clinical Trial Simulation (CTS) is a stochastic approach to predict the outcome of clinical trials and statistical power.
Drug Models
(Population PK/PD) describing exposure and response
Disease Models
describing the natural progression of the condition.
Trials Models
including dropout rates, adherence, and placebo effects.
Covariate Distribution
within the target patient population.
Connecting all this information in one model is possible with CTS analysis to help you better understand the variability of your trial outcomes and optimize your clinical strategy.
Study Design and Operational Success in Drug Development
Optimizing the study design and operational parameters is crucial in drug development. These elements determine how a study is powered, which patients are recruited, how endpoints are measured, and ultimately if the trial succeeds or fails.
Modeling and simulation, especially through CTS approaches, enable the prediction of these scenarios by considering the variability in drug response, disease progression, and patient behavior (such as compliance). These tools facilitate protocol optimization and risk assessment while reducing the likelihood of inconclusive or failed trials, thereby streamlining drug development and enhancing the probability of regulatory approval.
Your company already has data from Preclinical/Phase I/II studies; your drug candidate has demonstrated proof-of-concept; you have investigated dose-response relationships in patients: these results allow them to go further and start pivotal Phase III studies.
The CTS study approach enables you to test in silico different trial designs and statistical analysis plans that will be evaluated in confirmatory clinical trials.
In addition, by avoiding underpowered or poorly designed studies, CTS can also be considered as the most adapted tool to:
Evaluate
the likely magnitude of statistical power under different scenarios
Determine
optimal inclusion/exclusion criteria to enrich the study population
Support
the rationale for sample size calculations and sampling schedules.
Transform the Clinical Simulation to a Strategic Advantage
PhinC excels in the use of advanced CTS platforms such as MonolixSuite® and SAS® softwares.
For many years, we have enhanced our expertise in these softwares and established a strong partnership with Simulations Plus® to promote the best use of Pharmacometrics and CTS in drug development.