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W 29: SC Influence on the Cost of Conducting Clinical Trials and Impact on Pricing of Related Services: Evidence from a Pilot Study
Srinivas Guiri Pai Raikar
Compare the monitoring time spent per patient (pt.) recruited (onsite, offsite/remote) by the same Clinical Research Associate (CRA) for that very project at 3 different sites supported by different SCs
Analysis of time coded/pt. recruited by 8 CRAs across 10 projects, 30 project sites and 3 countries
The data showed that “Good” SCs reduced Clinical Research Associates’ (CRAs) monitoring time (onsite and offsite/remote) by 50%. Attributes of “Good” SCs were identified through in-depth qualitative interview with CRAs, and reinforced by a survey of 200 CRAs, of which 133 responded to these two questions 1) “Whom do you consider as ‘Good’ SCs?” 2) “What do they do that others don’t do?” The data analyzed to determine monitoring time differences included time coding across seven categories. To rule out bias, only those projects in which the same CRA monitored at least three different sites in the same project were considered. While it is well known that SC capabilities, proficiencies and cooperation level are likely to drive the monitoring efficiency, this study provides quantitative evidence regarding SC’s influence on time spent by a CRA on different aspects related to monitoring.
A 50% reduction in monitoring time is a strong indicator of SC influence on the direct costs of monitoring besides the influence on indirect costs which include timeliness (startup, CRF completion, data query resolution, action items), patient recruitment, retention, compliance, data quality and data integrity. Reduction in onsite monitoring days for a CRA will also reduce the travel costs. SC efficiency would translate into optimal utilization of staff at a site reducing the personnel related costs for the sites and hence the overall pricing at a site level. With the increasing use of Risk Based Monitoring (RBM) which determines the pricing of clinical trial related services, SCs will continue to have ever-increasing influence. These results warrant thinking around the overall hands on training and development of SCs besides Good Clinical Practice (GCP). It also provides quantitative evidence on significant Return on Investment (ROI) for the Sites as well as the Industry to improve SC proficiency with appropriate intervention.