The current clinical evaluation process is fraught with inefficiencies, resulting in exploding development costs and a compound failure rate of more than 80%. A New Paradigm for Clinical Development: The Clinical Trial in 2015 is a new CHA Advances Report that outlines an innovative and imaginative strategy for reinventing clinical development, and demonstrates why a complete overhaul of the clinical trials process is both necessary and feasible from a conceptual, technical and logistical point of view.

To view a table of contents for this report, please visit
http://www.advancesreports.com/all_reports/2005_59_Clinical_Trials/table_of_contents.html

A New Paradigm for Clinical Development: The Clinical Trial in 2015 proposes a bidirectional approach to accelerate the clinical process and make it more effective. These two avenues, which can be summarized as revamping trial design and as truly pervasive modelling and monitoring driven by information technology, are fundamentally different from each other but need to be implemented in a closely linked fashion. Though radical in effect, none of these changes would involve concepts or technologies that are unknown today.

According to the strategy laid out in the report, the following changes are required:

• Phase I will assume a new role as a brief confirmatory testing stage for the model for drug-human interactions that the sponsor has proposed.
• Phases II and III will merge into a single advanced-stage human testing phase involving fewer patients than today, relying on relatively small patient populations that are highly homogenous with respect to key criteria of pharmacological response.
• Systematic post-marketing studies and a significantly improved and extended post-marketing surveillance system that goes far beyond adverse event reporting will be integrated into a post-marketing monitoring phase that documents real-life use of the newly licensed drug.

These new processes will be made possible through holistic mathematical models such as the "virtual patient" (representing variants of target patients of both sexes, different ethnicities, various ages, and with medical conditions that typically coexist in this target population), extensive biomarker monitoring, and "pervasive computing" that will rely on the concept of seamless capture of every elementary act and equally seamless worldwide data exchange, driven by global standards.

With a full implementation of all envisaged changes by the year 2015, the stage would be set for a new world of drug development:

• The pre-approval clinical trial phase might be shortened to about three years and 40-50% of all candidate compounds that enter this stage could complete it, with the majority of the failures occurring in the early human validation phase.
• The crucial function of the advanced-stage human testing phase will be to determine whether efficacy is sufficiently superior over the established standard of therapy to warrant the cost of launch and the mandated post-marketing monitoring.
• Developers recoup development costs earlier and enjoy a longer life cycle under patent protection, but also benefit from more and closer attention to real-life use of the newly licensed drug.

For more information and pricing for A New Paradigm for Clinical Development: The Clinical Trial in 2015, please visit http://www.advancesreports.com/all_reports/2005_59_Clinical_Trials/table_of_contents.html or contact Cindy Ohlman at cohlman@advancesreports.com or 781-547-0202.

CHA Advances Reports are written by experts who collaborate with CHA to provide a series of reports that evaluate the salient trends in pharmaceutical technology, business, and therapy markets.

CHA Advances Reports, 1000 Winter Street, Waltham, MA 02451

http://www.advancesreports.com