Integrate Countersignature Trial with airSlate SignNow

Integrate countersignature trial

[Music] [Music] good afternoon everyone thank you for joining us and good morning to those of us on the west coast I'm HSN Chaudry from sight L and it's my pleasure today to introduce jay park who is a director for clinical research services at site L Canada Jay is a lecturer at McMaster University where he developed one of the first courses in the world on introduction to adaptive designs and master protocols as a result he will be speaking on that topic today I also want to mention that Jay is very active with the Bill and Melinda Gates Foundation where he is a member of the quantitative Sciences group and the knowledge integration unit so as you're watching this webinar and thinking of questions and know that he's happy to take questions on method on oncology but also their applications to global health with that in mind I will turn it over to Jay so I'm very excited to talk about some of the new advancements that we have made in terms of methods under the master protocol was called basket and umbrella trials so for today I'll be talking about two to two objectives are two objective for today versus to discuss the concept of master protocols and subtypes in basket and umbrella trials when we also discussed some of the important design considerations for these types of master protocols you know ever since in 1953 when we first discovered the actual structure of the DNA we have made various key milestones and advancements in genomics we have we now there's a rising interest in biomarkers and how they can be used to improve biomedical interventions and develop what's called targeted therapies towards more precision medicine and precision oncology efforts so so it is important to recognize how important biomarker to guide to try on how they're becoming central part of clinical trial research in the globally and what what I mean by targeted therapies is that it these are therapies that can specifically target the diseases based on genetic makeup or other predictive risk factors so you know ever since the first tumor agnostic therapies was approved by the FDA in 2017 the FDA among the other regulatory agencies have been vital in promoting these innovative methods and mastered protocols or also referred to as complex innovated designs and of course the European consensus consensus and statement was released a couple of months a couple months ago earlier this year so okay so we have to recognize that there's a change in clinical trial research especially in particularly oncology so there's number of increasing number of biomarker target therapies that are being investigated today and there and also being now proven in ecology we're now shifting away from all comers histology and organ specific cancer therapies and moving towards more molecularly sub to find cancer therapies as well as the tumor agnostic therapies that are independent of their histology and organ location and that can...