title: Postapproval Development Options in COPD: A Case Study in Value-Based Healthcare Systems.
abstract: BACKGROUND
  Research and development activities in an era of globalization encounter a mosaic of providers, products, services, and intermediaries; regulatory and other government institutions; and consumers. The introduction of novel therapeutics into this environment mandates research programs that are relevant to the registration process, payers and purchasers, transparent pricing, and rule-driven business practices, while providing data relevant to marketing initiatives internationally.
  
  
  OBJECTIVE
  To outline an example for clinical development programs that incorporate the perspective of multiple stakeholders into a portfolio of study designs to provide optimal data platforms that can resonate with diverse recipients.
  
  
  CONCLUSIONS
  A contract research organization directly involved in the design, execution, and analysis of clinical trials for new drugs and devices across pharmaceutical and biotechnology companies provides a unique perspective regarding opportunities and challenges within the international clinical research environment. Drs Murphy, Antonini, and Lai, representing Worldwide Clinical Trials, utilize chronic obstructive pulmonary disease as a demonstration project exploiting its prevalence, direct and indirect costs, and the rapid infusion/diffusion of innovative therapy into practice as a rationale for focus, and illustrate methods of informing registration and technology assessments during a prototypical development process.
  
  
  CONCLUSIONS
  By virtue of its chronicity, prevalence, and pattern of healthcare utilization, chronic obstructive pulmonary disease provides an ideal case for illustrating the application of clinical trial methodology that can facilitate data evaluation through the prism of multiple stakeholders. Adding an international dimension exacerbates system complexity and serves to illustrate the breadth of issues that can be addressed within this therapeutic area.
authors.affiliation: Chief Medical Officer and Scientific Officer, Worldwide Clinical Trials, King of Prussia, PA, and Research & Development Editor for American Health & Drug Benefits.
authors.forename: Michael F
authors.initials: MF
authors.lastname: Murphy
authors.affiliation: Senior Vice President, Medical and Scientific Affairs, Drug Safety, for Worldwide Clinical Trials.
authors.forename: Paola
authors.initials: P
authors.lastname: Antonini
authors.affiliation: Associate Director, Medical and Scientific Affairs, Worldwide Clinical Trials.
authors.forename: Zhihong Vicki
authors.initials: ZV
authors.lastname: Lai