New paper on the affordances of clinical research participation
What is your current role in EPAD?
I am a co-lead of Work Package 2 – The Statistical Engine Room. The Statistical Work Package has two main focuses in the EPAD project – the design of the proof-of-concept platform trial and the disease modeling work from the Longitudinal Cohort Study (LCS). I have been focused on working with the EPAD team to create a platform trial design for the phase 2 proof-of-concept trial (PoC). This will allow multiple therapies to be investigated simultaneously in the same protocol creating a great deal of synergy – for example sharing controls across arms.
What did you do prior to joining EPAD?
I am a PhD Statistician and President at Berry Consultants, a statistical consulting company specializing in designing adaptive and innovative trial designs, typically from a Bayesian perspective. We work for a wide range of sponsors – large and small pharma, device companies, federally funded trials, and NGO based efforts. We work on designing flexible adaptive trials. This process involves creating the modeling and adaptive features of a design. Typically, this involves detailed clinical trial simulations in order to optimize the design – making sure that the adaptive features, modeling and threshold are all optimized for the goals of the trial. The design of adaptive trials is a very detailed process of iterative trial design aspects tied to detailed clinical trial simulations. Traditional, fixed, trials can be understood with pencil-and-paper calculations, but more complex trial designs are simulated to understand their behavior – much like the simulation design of airplanes, automobiles, and bridges – well almost everything nowadays. Trials constructed through simulations have been given the moniker of “complex” innovative trials. This has been the space of trial designs we have been working on.
Recently platform trials have been gaining in popularity. The I-Spy2 trial was one of the first platform trails (with more than 14 different experimental agents moving through the phase 2 trial) and its popularity and growing need for more efficient methods have led to this growth and demand for platform trials. Platform trials are being constructed in multiple cancers, ALS, Duchenne muscular dystrophy, various infectious diseases, PTSD, as well as familial Alzheimer’s. These trials typically fall in this bucket of complex trial designs.
Tell us a bit about the institution/company/organisation you work for.
Berry Consultants has offices in the UK and the United States, and we focus on statistical innovation – typically tied to the design and analysis of innovative trial designs. Berry Consultants is approaching its 20th year – after being founded in 2000 by Don Berry and myself. We have since grown to more than 30 employees – experts in statistics, clinical trials, and clinical trial simulation. In addition to the design of trials, Berry Consultants has created and continues to develop a software package for clinical trial simulations, for the evaluation and optimization of trial designs (Fixed and Adaptive Clinical Trial Simulator, FACTS).
What are your expectations from the EPAD project?
I have incredibly high hopes for EPAD. I believe the PoC trial that comes out of the EPAD project will continue perpetually as long as there is a need in the slowing and prevention of Alzheimer’s disease. The project is unique in the construction of the LCS feeding to the PoC trial. I believe the PoC trial will prove to be an incredibly efficient ‘machine’ for phase 2 Alzheimer’s drugs – which will decrease costs, improve timelines, and ultimately improve the industries ability to investigate experimental drugs. Not only will this have substantial impact on Alzheimer’s disease but the project itself will likely become a model project that can be emulated in many other diseases.
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