Newsletter | September 9, 2020

09.09.20 -- How Adaptive Design Approaches Aid Early Oncology Studies

Early-Phase Oncology: Emerging From The Crisis And Innovating For The Future

As the world emerges from the pandemic of novel coronavirus disease (COVID-19), the treatment need for cancer patients is greater than ever. This podcast outlines how the pandemic has impacted the oncology clinical trial environment and provides considerations for managing ongoing cell and gene therapy (CAGT) trials while looking ahead to the future of oncology research.

Minimizing Early-Stage Oncology Failures With Adaptive Design Approaches

Despite advances in our understanding of the complex genetic, molecular, and immunological factors which lead to cancer, the success and likelihood of approval rates for oncology remain low. Adaptive design approaches are well suited for helping sponsors optimize dose and dosing regimen, while also narrowing down the indications of interest.

Considerations For Applying Adaptive Design Approaches To Early Oncology Studies

Adaptive design approaches can be applied across all phases of clinical development, including early oncology studies. These designs introduce real-time flexibility while a trial is underway, including the capability to select biomarker subgroups that identify patients more likely to respond to treatment, allow dynamic adjustment of dose schedules, adjust the size of the trial, or even combine two separate trial phases into a single seamless trial.

Mapping The New Landscape Of Orphan Drug Development

The marketplace for orphan drugs is growing, and changes in the regulatory landscape are providing favorable conditions for collaboration in the area of drug development in rare diseases. Understanding the regulatory and operational nuances of orphan drug development can help sponsors position their promising compounds for clinical and commercial success.