title: Lessons learned: Infrastructure development and financial management for large, publicly funded, international trials.
abstract: OBJECTIVE
  Randomized clinical trials are widely recognized as essential to address worldwide clinical and public health research questions. However, their size and duration can overwhelm available public and private resources. To remain competitive in international research settings, advocates and practitioners of clinical trials must implement practices that reduce their cost. We identify approaches and practices for large, publicly funded, international trials that reduce cost without compromising data integrity and recommend an approach to cost reporting that permits comparison of clinical trials.
  
  
  METHODS
  We describe the organizational and financial characteristics of The International Network for Strategic Initiatives in Global HIV Trials, an infectious disease research network that conducts multiple, large, long-term, international trials, and examine challenges associated with simple and streamlined governance and an infrastructure and financial management model that is based on performance, transparency, and accountability.
  
  
  RESULTS
  It is possible to reduce costs of participants' follow-up and not compromise clinical trial quality or integrity. The International Network for Strategic Initiatives in Global HIV Trials network has successfully completed three large HIV trials using cost-efficient practices that have not adversely affected investigator enthusiasm, accrual rates, loss-to-follow-up, adherence to the protocol, and completion of data collection. This experience is relevant to the conduct of large, publicly funded trials in other disease areas, particularly trials dependent on international collaborations.
  
  
  CONCLUSIONS
  New approaches, or creative adaption of traditional clinical trial infrastructure and financial management tools, can render large, international clinical trials more cost-efficient by emphasizing structural simplicity, minimal up-front costs, payments for performance, and uniform algorithms and fees-for-service, irrespective of location. However, challenges remain. They include institutional resistance to financial change, growing trial complexity, and the difficulty of sustaining network infrastructure absent stable research work. There is also a need for more central monitoring, improved and harmonized regulations, and a widely applied metric for measuring and comparing cost efficiency in clinical trials. ClinicalTrials.gov is recommended as a location where standardized trial cost information could be made publicly accessible.
authors.affiliation: Coordinating Centers for Biometric Research, Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA larso279@umn.edu.
authors.forename: Gregg S
authors.initials: GS
authors.lastname: Larson
authors.affiliation: The Kirby Institute, University of New South Wales, Sydney, NSW, Australia.
authors.forename: Cate
authors.initials: C
authors.lastname: Carey
authors.affiliation: Copenhagen HIV Programme, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Jesper
authors.initials: J
authors.lastname: Grarup
authors.affiliation: Medical Research Council, London, UK.
authors.forename: Fleur
authors.initials: F
authors.lastname: Hudson
authors.affiliation: Sponsored Projects Administration, University of Minnesota, Minneapolis, MN, USA.
authors.forename: Karen
authors.initials: K
authors.lastname: Sachi
authors.affiliation: Veterans Affairs Medical Center, Washington, DC, USA.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Vjecha
authors.affiliation: Veterans Affairs Medical Center, Washington, DC, USA.
authors.forename: Fred
authors.initials: F
authors.lastname: Gordin
mesh_terms: D003363:Cost Control; D005380:Financing, Government; D015658:HIV Infections; D038622:Internationality; D016730:Program Development; D016032:Randomized Controlled Trials as Topic / Q000191:economics*
keywords: Infrastructure development; financial management; international trials; large trials; publicly funded trials