Global CRO Icon of Dublin, Ireland, has released the book Re-Engineering Clinical Trials, edited and co-authored by Brendan Buckley, Icon’s chief medical officer, and Peter Schüler, ICON’s senior vice president of global medical and safety services.

Joined by co-authors at AstraZeneca, Bayer, Boehringer Ingelheim, IBM, McGill University, the Tufts Center for the Study of Drug Development and 22 other institutes and companies, Buckley and Schüler present a collection of reforms for a progressive model of drug development, hoping to propel faster change in some businesses increasingly restrained by companies, not regulators.

In the book, Icon and industry leaders have asked and answered some critical questions about the fundamentals of clinical development.

“For example, what causes good drugs to fail? Why do so many expenditures in clinical trials not benefit patients? Have other industries already invented what we need? The answers can spur reforms of fundamental processes that, when implemented together, represent a new business model for drug development,” said Buckley.  

The editors argue that most of the reforms do not require invention of new technologies or methodologies. The necessary innovations are either available in other industries or already have received regulatory approval and are in use in clinical trials.

“Knowledge of beneficial reforms remains siloed and not widely disseminated, making it difficult to build momentum for change. This book is part of the process for stimulating evolution of businesses by presenting these as a package for a suggested way forward,” said Schüler.

The book, published by Elsevier, compiles factual reviews of critical reforms with express regulatory support, including:

• Failure Mode and Effects Analysis (FMEA) and other techniques from outside industries
• Centralized trial monitoring constructed through FMEA
• Site staff hiring, training and performance analysis
• Innovative trial designs, including use of surrogate endpoints and adaptive designs
• Patient-centred recruitment and engagement
• Protocol design and data mining
• Unstructured data management
• Connected health, the clinical trial app and patients as investigators.