Registration has now opened for a site-metrics registry that represents the first fruit of an initiative by academic research centres in the US to streamline clinical-research processes by working together online.
The new Research Resonance Network is hosted by Forte Research Systems, which develops and markets clinical and translational research-management software, including its flagship OnCore eClinical solution.
The network’s inaugural Site Metrics Registry is the culmination of a seven-year effort to optimise the use of site-performance metrics in clinical research, driven to a large degree by 20 leading academic medical centres such as the Yale Center for Clinical Investigation and Indiana University Simon Cancer Center.
The Research Resonance Network Site Metrics Registry at www.ResearchResonance.net is a library of standard data definitions for a range of performance measurements: for example, cycle times in areas such as Institutional Review Board approval and contracting; the size of clinical-research operations (e.g., number of open protocols and new subject accruals); and effort put into activities like data management and budgeting.
Forte offers the service free of charge to academic research centres that enter into a data-sharing agreement and contribute their metrics to the registry.
Security mechanisms enable the centres to compare their performance with anonymous data aggregated from their peers. Forte acts as a ‘trusted third party’, ensuring that the privacy of all participants is maintained and nothing is shared that would allow participating centres to be identified.
Not sustainable
There is growing interest in improving the processes around clinical-trial execution, Forte Research Systems noted.
“Most stakeholders in the drug development industry agree that the current environment is not sustainable,” it said.
Moreover, the National Cancer Institute and the National Center for Advancing Translational Sciences in the US have undertaken “major” process-improvement efforts as they look for ways to speed up the development of new therapies.
As things stand, research protocols “are getting more complicated, study start-up is labour-intensive and inefficient, and centres face challenges in everything from compliance to financial viability,” commented Srini Kalluri, Forte’s founder, president, chief executive officer and chief customer officer.
The opportunity to benefit from knowledge gained at comparable institutions “will be an asset to our entire research enterprise at Yale and to the Yale Cancer Center”, said Dr Thomas Lynch, director of the Yale Cancer Center.
“The ability to access data anytime we need it and compare our institution to other cancer centers, CTSA [Clinical and Translational Science Award] sites, or academic medical centres is a great way to establish our own goals and will be a necessity if we want to better our performance.”
