title: The future of drug development: advancing clinical trial design.
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.
authors.affiliation: Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, New Jersey 07936, USA. john.orloff@novartis.com
authors.forename: John
authors.initials: J
authors.lastname: Orloff
authors.forename: Frank
authors.initials: F
authors.lastname: Douglas
authors.forename: Jose
authors.initials: J
authors.lastname: Pinheiro
authors.forename: Susan
authors.initials: S
authors.lastname: Levinson
authors.forename: Michael
authors.initials: M
authors.lastname: Branson
authors.forename: Pravin
authors.initials: P
authors.lastname: Chaturvedi
authors.forename: Ene
authors.initials: E
authors.lastname: Ette
authors.forename: Paul
authors.initials: P
authors.lastname: Gallo
authors.forename: Gigi
authors.initials: G
authors.lastname: Hirsch
authors.forename: Cyrus
authors.initials: C
authors.lastname: Mehta
authors.forename: Nitin
authors.initials: N
authors.lastname: Patel
authors.forename: Sameer
authors.initials: S
authors.lastname: Sabir
authors.forename: Stacy
authors.initials: S
authors.lastname: Springs
authors.forename: Donald
authors.initials: D
authors.lastname: Stanski
authors.forename: Matthias R
authors.initials: MR
authors.lastname: Evers
authors.forename: Edd
authors.initials: E
authors.lastname: Fleming
authors.forename: Navjot
authors.initials: N
authors.lastname: Singh
authors.forename: Tony
authors.initials: T
authors.lastname: Tramontin
authors.forename: Howard
authors.initials: H
authors.lastname: Golub
mesh_terms: D001499:Bayes Theorem; D017322:Clinical Trials, Phase II as Topic / Q000191:economics / Q000379:methods*; D017326:Clinical Trials, Phase III as Topic / Q000191:economics / Q000379:methods*; D003362:Cost-Benefit Analysis; D015195:Drug Design; D004345:Drug Industry / Q000191:economics / Q000458:organization & administration; D017598:Efficiency, Organizational; D006801:Humans