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I-SPY Platform

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Widely hailed as the future of phase II drug development, the adaptive I-SPY2 platform trial has set a new benchmark for efficiency, through innovation in trial design and clinical operations.

Reviews & Editorials on I-SPY 2

Das S, Lo AW
.
Re-inventing drug development: A case study of the I-SPY 2 breast cancer clinical trials program
.
Contemp Clin Trials
62
:
168-174
, 
2017
.
pdf
doi link
Messmer MF, Wilhelm EE, Shoulson I
.
I-SPY 2 Breast Cancer Trial as a Model for Innovation in Alzheimer Disease Therapies
.
JAMA Neurol
74
:
1027-1028
, 
2017
.
pdf
doi link
Bartsch R, de Azambuja E
.
I-SPY 2: optimising cancer drug development in the 21st century
.
ESMO Open
1
:
e000113
, 
2016
.
pdf
doi link
Esserman L
.
The I-SPY Approach to Drug Development (Interview)
.
Clin Adv Hematol Oncol
14
:
782-784
, 
2016
.
pdf
doi link
Harrington D, Parmigiani G
.
I-SPY 2 — A Glimpse of the Future of Phase 2 Drug Development?
.
NEJM
375
:
7-9
, 
2016
.
pdf
doi link
Printz C
.
I‐SPY 2 may change how clinical trials are conducted
.
CancerScope
119
:
1925-1927
, 
2013
.
pdf
doi link

I-SPY2 Video

Accelerating knowledge turns: the I-SPY model and drug development
I-SPY Principal Investigator Laura Esserman's lecture at 'Rejuvenation Biology 2014' discussing how we can accelerate the pace of new drug development in oncology, including the role for adaptive platform trials.
Length: 31:37 min
Reinventing clinical trials
Laura Esserman's 2015 lecture at 'Exponential Medicine' discussed the re-engineering of clinical trials, inspired by the insights of late Intel CEO Andy Grove into the differences between development in the semiconductor industry and healthcare.
Length: 26:50 min
I-SPY 2 and other platform trials
I-SPY2 Principal Statistician Don Berry of Berry Consultants explains the history and fundamentals of platform trial models and how they are changing drug development in breast cancer and beyond.
Length: 31:52 min
I-SPY Clinical Trials: And interview with Dr. Laura Esserman
Dr. Laura Esserman, director of the Carol Franc Buck Breast Care Center at University of California San Francisco, sits down with Rebecca Knight from MIT Lab for Financial Engineering to discuss the innovative I-SPY breast cancer clinical trials.
Length: 38:18 min
Changing strategies in the 'war on cancer'
Dr. Angela DiMichele, Professor of Medicine and Epidemiology at the Perelman School of Medicine at the University of Pennsylvania and I-SPY 2 Site Operations Working Group Chair discusses the innovations of I-SPY 2 and testing of new antibody-drug conjugates.
Length: 34:32 min
How to design an adaptive trial - Lessons learned, so far
How do you design an adaptive trial? Scott Berry one of the adaptive trial experts at Berry Consultants presents a recipe for designing a high-impact adaptive trial, secret sauce included.
Length: 38:18 min
Reinventing clinical trials
Laura Esserman's 2015 lecture at 'Exponential Medicine' discussed the re-engineering of clinical trials, inspired by the insights of late Intel CEO Andy Grove into the differences between development in the semiconductor industry and healthcare.
Length: 26:50 min

The I-SPY Trials

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