Perspectives
Nature Reviews Drug Discovery, advance online publication, Published online 9 October 2009 | doi:10.1038/nrd3025
Article series: A guide to drug discovery
Opinion: The future of drug development: advancing clinical trial design
John Orloff1, Frank Douglas2, Jose Pinheiro1, Susan Levinson3, Michael Branson1, Pravin Chaturvedi4, Ene Ette5, Paul Gallo1, Gigi Hirsch6, Cyrus Mehta7, Nitin Patel6, Sameer Sabir6, Stacy Springs6, Donald Stanski1, Matthias R. Evers8, Edd Fleming8, Navjot Singh8, Tony Tramontin8 & Howard Golub6 About the authors
Abstract
Declining pharmaceutical industry productivity is well recognized by drug developers, regulatory authorities and patient groups. A key part of the problem is that clinical studies are increasingly expensive, driven by the rising costs of conducting Phase II and III trials. It is therefore crucial to ensure that these phases of drug development are conducted more efficiently and cost-effectively, and that attrition rates are reduced. In this article, we argue that moving from the traditional clinical development approach based on sequential, distinct phases towards a more integrated view that uses adaptive design tools to increase flexibility and maximize the use of accumulated knowledge could have an important role in achieving these goals. Applications and examples of the use of these tools — such as Bayesian methodologies — in early- and late-stage drug development are discussed, as well as the advantages, challenges and barriers to their more widespread implementation.
Author affiliations
- John Orloff, Jose Pinheiro, Michael Branson, Paul Gallo and Donald Stanski are at Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, New Jersey 07936, USA.
- Frank L. Douglas is at the Austen BioInnovation Institute, 1 South Main Street, Suite 401, Akron, Ohio 44308, USA.
- Susan Levinson is at The Strategic Choice LLC, 6 East Cove Lane, Morristown, New Jersey 07960, USA.
- Pravin Chaturvedi is at Napo Pharmaceuticals, 250 East Grand Avenue, Suite 70, South San Francisco, California 94080, USA.
- Ene Ette is at Anoixis Corporation, 214 North Main Street, Suite 104, Natick, Massachusetts 01760, USA.
- Gigi Hirsch, Nitin Patel, Sameer Sabir, Stacy Springs and Howard Golub are at the Center for Biomedical Innovation, Massachusetts Institute of Technology, 77 Massachusetts Avenue (E19-611), Cambridge, Massachusetts 02139-4307, USA.
- Cyrus Mehta is at Cytel Statistical Software and Services, 675 Massachusetts Avenue, Cambridge, Massachusetts 02139, USA.
- Matthias R. Evers, Edd Fleming, Navjot Singh and Tony Tramontin are at McKinsey & Company, Inc., Am Sandtorkai 77, 20457 Hamburg, Germany.
Correspondence to: John Orloff1 Email: john.orloff@novartis.com
Published online 9 October 2009
