What is the difference between an umbrella trial and a basket trial?

[Music] What is the difference between an umbrella trial and a basket trial? Umbrella trials or platform trials are related concepts. In this you test several different drugs in one disease. But again, these typically are biomarker driven. So for example, if you have a drug, A target's gene X drug B targets gene, and drug C targets Gene Z if there's a mutation or other type of biomarker that characterizes the patients who respond to individual drugs, then that is what drives the selection of treatment for patients. So there's usually some form of screening, whether it's genomic sequencing or looking specifically for expression of that biomarker. And then the treatment that the patient receives is determined by that. They'll get drug A, B and C or C, depending on what their biomarker expression is. And there's a couple of big trials that are underway about testing that concept. So, for example, the NCI is running the match trial. The MRF is actually running the my drug trial in myeloma testing this type of approach. In other words, rapidly investigating whether biomarker driven therapies across several different drugs will be effective in a given disease. What are basket trials? New trial designs are being introduced to try to accelerate treatment. In other words, if you have a promising treatment, you want to get it out to as many people as possible who might be eligible. So a basket trial is designed to test a new agent in several different diseases at once. And usually this is driven by some sort of biomarker. So, for example, if you have a drug X that targets mutations in gene Y, then you can have a basket trial where you look at six or seven different kinds of cancers, all of which commonly have that mutation in gene Y. So then if patients have that mutation, regardless of whether they have lymphoma or myeloma or whatever, then we can treat them with this drug. Okay. So it's typically a biomarker driven trial of one agent in several different diseases. In a basket trial if I have a biomarker, will I automatically get a corresponding drug? So basket trials are intended to be early phase trials. So early phase trials are what we call open label. In other words, everybody who enrolls in the trial gets treated with the investigational agent. So there's no randomized to a control arm, there's no placebo arm, for example, or anything like that. Everybody who is enrolled in the trial, typically based on the presence of that biomarker, will get treated with the drug of interest.  [Music]