In clinical research and development, comparison to a control is highly recommended by regulatory agencies for the purpose of demonstrating evidence of clinical efficacy of a drug or device. The control could be a placebo, a known standard-of-care or an available market-approved drug or device. With some diseases or certain classes of devices, a viable control (prospective or retrospective) may not be feasible for ethical or pragmatic reasons. In addition, this problem is not uncommon in the biotech and medtech industries.
This creates the need for alternative approaches for carrying out comparative evaluation. Computational Modeling and Simulation (CM&S) has been identified by the US Food and Drug Administration (FDA) as a necessary component for developing in silico trial designs, in which the comparator arm is generated using CM&S techniques. The FDA encourages the use of in silico clinical trials in which a drug or device is tested against a cohort of virtual patients, therefore providing an empirical basis for appropriate comparative assessment.
Understanding clinical outcomes, safety, effectiveness and developmental challenges early can impact the investment sponsors put forth towards a new compound or device. Innovative trial designs are needed to maximize existing outcomes data and to leverage advanced computational techniques for making increasingly better decisions, accelerate product development and decision making, while reducing overall R&D costs.
Join Premier Research and InSilicoTrials Technologies for this joint webinar and explore the potential for including in silico modeling & simulation as an integral part of the product development plan.
Key Learning Objectives:
- Understanding the value of in silico modeling and simulation in product development
- US Food and Drug Administration (FDA)’s position on in silico methods for evaluating drugs and devices
- A practical example of utilizing in silico data as a synthetic control arm in clinical trials
- When is the right time to utilize in silico modeling for products
Nach Davé, RPh, MS
Vice President, Development Strategy, Premier Consulting
Abie Ekangaki, PhD
Vice President, Statistical Consulting, Premier Consulting
Roberta Bursi, PhD, PMP
Co-Founder and Executive Vice President of Research and Development, InSilicoTrials Technologies