We are excited to announce an upcoming webinar in our Trial Innovations Series. “Basket Trials: Design and Implementation Considerations” on 4th December 2018 at 11am EST. Noted basket trial expert, Robert (Bob) Beckman will share his most recent experiences with Cytel Strategic Consulting Statistician Sam Hsiao on expanding the application of this innovative breed of trials. Bob acts as a trial design consultant to biopharma companies in addition to his role as Professor of Oncology and Biostatistics, Bioinformatics, and Biomathematics at Lombardi Comprehensive Cancer Center and the Innovation Center for Biomedical Informatics, Georgetown University Medical Center.
The webinar will draw together Bob’s focus in confirmatory studies, with Sam's experience in designing exploratory basket trials. In our one hour format, they’ll review the supporting methodologies, then examine the design & implementation considerations of a generalizable study. There will also be the opportunity for questions from the online audience as time allows.
So, what is the context of the rising interest in basket trials?
In a 2017 interview with the Cytel blog Bob distinguished between “exceptional drugs” to fight cancer and treatments that are “effective at a more normal level”. He questioned whether industry has been so intent on developing breakthrough “exceptional” treatments, that we’ve not focused sufficiently on creating innovative approaches that can apply to, and benefit a wider range of clinical research programs.
Bob is among the growing group of trial designers now advocating for wider use of basket trials to address a key conundrum of modern drug development. As science produces more and more possibilities, it's becoming even more cost unsustainable to research and successfully develop new medicines. In other words, success rates aren’t keeping up with the number of interesting possibilities to research. Basket trial design and related “umbrella” trials) have the potential to help resolve this challenge and improve efficiency. This is in an environment of increasing general support and interest from industry and regulators in developing further understanding of complex, innovative designs to accelerate development.
So, what’s appealing about a “basket” research approach?
Basket designs test whether a drug is effective in multiple indications at once. Think about that for a moment. In comparison to identifying a specific candidate for a specific cancer type the basket approach provides valuable data on a number of indications for a single experimental agent.
For example, if three to five indications are grouped by a fundamental characteristic, such as the same mutation, or same biomarker -with a basket trial you could conduct trials for three to five “basketed” indications at approximately the same cost as a single study. Naturally, this is extremely compelling for trial sponsors.
What will our webinar focus on?
To date, basket trials have been used generally for two purposes. One is for exploratory work to learn if there’s potential activity – a positive signal early on. The other is for confirmatory studies of those exceptional drugs already mentioned. Our December 4th webinar will bridge the gap between those two extremes, along with specifics on controlling type-1 and Family Wise Error Rates (FMER). Bob Beckman and Sam Hsiao will help clinicians, statisticians, and development stakeholders to overcome the technical and practical challenges that inhibit wider adoption of this new breed of trials.
Join us and:
- Learn to distinguish umbrella and basket trials, exploratory and confirmatory basket trials
- Gain insights into methodological issues for confirmatory basket trials including control of the false positive rate
- Understand how to overcome challenges in implementation from multiple stakeholder perspectives
- Achieve understanding of the regulatory perspective