In terms of cancer clinical trials, what is an umbrella trial?

An umbrella trial is designed to test multiple drugs within one specific type of cancer, simultaneously assessing different treatments targeting various molecular subtypes or pathways of that cancer. This approach allows researchers to gather data on the efficacy of these different medications in a shared setting, which can streamline the process of determining which treatments may be most effective for certain patient populations.

This design is particularly beneficial in oncology, as tumors can be heterogeneous—not all patients with the same type of cancer respond to the same treatments. By focusing on one cancer type but exploring multiple therapeutic options, umbrella trials can provide valuable insights into which drugs might be most effective based on the specific characteristics of the tumor.

In contrast, evaluating multiple cohorts for one drug across different tumors corresponds to a different trial structure commonly referred to as a basket trial. Assessing the same drug at varying dosages would represent a dose-ranging study, which is primarily concerned with safety and efficacy within a certain dosage range. Lastly, comparing standard care against new therapies is indicative of a traditional randomized controlled trial design, which seeks to establish the superiority or equivalence of a new treatment compared to existing options. Each of these methodologies serves distinct purposes in clinical research, with the umbrella trial being uniquely focused on multiple interventions for a single cancer type.