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Lessons learned: Infrastructure development and financial management for large,
publicly funded, international trials
#MMPMID26908541
Larson GS
; Carey C
; Grarup J
; Hudson F
; Sachi K
; Vjecha MJ
; Gordin F
Clin Trials
2016[Apr]; 13
(2
): 127-36
PMID26908541
show ga
BACKGROUND/AIMS: 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. CONCLUSION: 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.
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