We may be familiar with adaptive designs, but their complexity has made them difficult to implement and their benefits are still not widely recognized. An awareness has to be created on why it is a good idea to use adaptive trials, for regulators, investigators and patients. In a recent interview with International Clinical Trials Magazine, Dr. Yannis Jemiai, Chief Scientific Officer at Cytel, discusses the impact of Bayesian and adaptive clinical trial designs amid COVID-19, and their potential for adoption post-pandemic.
Irrespective of the size of your organization, innovative trial designs can aid in improved clinical development, better pre-planning, greater patient safety, less medical waste, and/or increased knowledge. These designs enable researchers to mitigate uncertainty by pre-planning ways to adapt as they learn. They are also very helpful in dealing with uncertainty and the variability in the data that is collected during clinical trials. However, sponsors need skilled statisticians to work alongside the trial design team and other members of a clinical operations team to decide whether a trial should be adaptive. Recent technological advances have played a significant role in making adaptive designs simpler to adopt and more accessible to statisticians.
Advanced quantitative techniques such as Bayesian statistics allow us to make probabilistic inferences on the parameter of interest, which is missing in a traditional frequentist approach. An adaptive Bayesian design uses Bayesian updating techniques to make decisions throughout the course of a trial. The COVID-19 pandemic elevated the challenge of designing and executing clinical trials within a substantially shortened time frame, and with limited data on the course of a newly emerged disease. In such a scenario, Bayesian statistical methods are very well suited to identifying efficacious interventions without compromising on patient safety and scientific rigor, as they can adapt to knowledge that is gained during a trial. In the interview, Yannis explains how the use of these innovative designs will only increase post pandemic.
The pandemic has also led to creating more awareness around Master Protocols that encompass a number of different statistical trial designs, which can test multiple therapies and multiple population subgroups, under a single protocol. Master Protocols can include basket and umbrella designs, various adaptive platform trials, and several complex studies. Adaptive platform designs form an efficient way to test for therapies which have been shown to not be effective for advanced stages of COVID-19, but which might prove beneficial in earlier phases.
Click the button below to read the complete interview. Learn about the benefits of adaptive platform trials and the future landscape of Bayesian designs.
About the Author of Blog:
Mansha Sachdev specializes in content creation and knowledge management. She holds an MBA degree and has 11 years of experience in handling various facets of marketing, across industries. At Cytel, Mansha is a Content Marketing Manager and is responsible for producing informative content that is related to the pharmaceutical and medical devices industries.