Innovations in Oncology Trial Design & Development Webinar Series

May 12, 2020

In our previous blog, “Remote Working Arrangement – How to get it right?”, we talked about how the need for social distancing has led most of the employers, across the globe, to make work-from-home arrangements for their employees. As we continue to stay indoors and combat COVID-19, keeping aside some time every day to read and watch useful resources on important industry topics can be very helpful. Cytel's team of oncology trial design and advanced analytics experts have been hosting a series of complimentary webinars covering a range of innovative topics including adaptive design, machine learning, estimands and trial design software. In this post, we offer you a recap of the webinars we conducted in the past few weeks. You can register for the upcoming webinars in our oncology series by clicking on the button below.

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Key Design Considerations for Basket Trials and Umbrella Trials

With advancements in biomarkers and momentum in precision medicine, biomarker-guided trials such as basket trials and umbrella trials have been developed under the master protocol framework. We spoke with Jay Park, Director, Cytel, about the concept of master protocols, their importance and future growth potential.

In this webinar, Jay introduces two types of master protocols and explores their extension to design in various contexts from the HIV epidemic in global health to expedited oncology trials. The purpose of this webinar is two-fold: firstly, to review the concept of master protocols and common characteristics of basket and umbrella trials; and secondly, to discuss important design considerations for these types of master protocols.

 

Transparent Machine Learning in Oncology

Machine learning (ML) aims to discover patterns from data that can be used for prediction. There is a growing interest in ML as it is being widely used for various purposes by many pharmaceuticals, biotech companies and healthcare providers. It is also being used as a part of analyzing real-world data to inform clinical trial design and adaptive trials, for looking at things like eligibility criteria, endpoints and surrogates for planning a trial. As the adoption of machine learning is on the rise, we interviewed Alind Gupta, Machine learning specialist at Cytel, about the differences between black-box models and transparent machine learning, and how the latter is becoming more important in clinical research today.

In this webinar, Alind gives us a deep dive into Bayesian networks - a transparent and flexible machine learning method. Transparent machine learning is simply about building interpretable models from the ground up so that there is transparency about how they work. The key idea of Bayesian networks models is to perform computations on a Directed Acyclic Graph (DAG). They have the advantage of being able to work with real-world data without the need to impute missing values. Additionally, they can also be used to model multiple correlated outcomes together in a single model.

 

Phase 1 Dose Escalation Trials with ESCALATE

East® ESCALATE is the new East software module to design, simulate, and operationally support Phase 1 dose escalation trials in determining maximum-tolerated dose (MTD). In addition to the popular 3+3 design, East® ESCALATE includes the modified Toxicity Probability Interval (mTPI) method, the Continual Reassessment Method (CRM), and the Bayesian Logistic Regression Model (BLRM).

In this webinar, Cytel Consulting adaptive trial design expert, Pantelis Vlachos, enables you to better characterize the maximum tolerated dose to improve your probability of success in later trials. The presentation will help you understand a range of different methodologies that are used in Phase 1 dose escalation trials and communicate findings to the clinical team using East’s intuitive graphs and tables. It also offers lessons on how to simulate a dose escalation design followed by single-arm cohort expansion.

 

A Clinician’s Perspective on Cancer Drugs Development

Design and conduct of clinical cancer trials have significantly evolved over the past few decades. From simple designs, we have now reached a stage of using complex innovative designs including basket trials and umbrella trials.

In the webinar, Professor Martin Fey, an experienced board-certified Medical Oncologist, presents the various and sometimes irreconcilable aims of clinical trials testing of a new drug or new treatment, from patients’ perspective. The treatment goals in this scenario are varied: achieving a longer and/or healthier life for the patients, achieving higher quality of life, etc. He provides us with a list of current curative systemic cancer treatment, and how we arrived at them through decades of evolution of cancer therapies, since the 1950s. He also speaks about the “new” side effects of various immunotherapies, for example, cardiotoxicity resulting from Anti–HER2 MAB therapy in metastatic HER2+++ breast cancer (trastuzumab).

Read an interview with Professor Fey about the evolution of clinical cancer trials, the difference between clinically meaningful and statistically significant results, the debate around patient perspectives and other important topics around cancer drugs development.

 

Conducting Sample Size Reassessment with Time-to-event Endpoints

Pantelis Vlachos, Principal Strategic Consultant at Cytel, provides an overview of the SURVIVAL and SURVADAPT modules in this webinar. Dealing with time-to-event endpoints, this will enable you to increase your sample size when your results look promising but lack the targeted power.

This webinar will help you learn how to use simulation tools to illustrate complex survival data at the design stage. It will enable you to explore trade-offs between duration and patient accrual, choice of boundaries, spending functions and hazard functions. Pantelis also offers insights on how to utilize the promising zone to determine increases in sample size given information acquired during the trial.

 

Upcoming Oncology Webinars:

Refocus Your Enrollment to the Subpopulation of Interest with ENRICH

Wednesday, May 13, 11AM EDT

Pantelis Vlachos, Principal, Strategic Consulting, Cytel

 

Oncology and Rare Disease

Thursday, May 14, 12pm EDT

Natasa Rajicic, Executive Advisor, Strategic Consulting

 

Oncology and Estimands

Thursday, May 21, 11am EDT

Monte Jarvis, Executive Advisor, Strategic Consulting

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