Today's post comes from Simon Wilson, Subject Matter Expert, Clinical, ArisGlobal. Simon started his career in clinical research at a site and lab level before progressing though data management, clinical operations, clinical technology and process implementation leadership posts at Bayer, PAREXEL and CSL. Over 15 years’ experience in head office and affiliate Pharma and CRO settings have provided Simon with a thorough understanding of this topic. Simon has a keen interest and expertise in unlocking the potential of eClinical applications.
Part three: how a unified EDC, ePRO and RTSM solution reduces spend on trial supplies and enables rapid and cost effective database lock
In the first two parts of this blog series [Part 1] [Part 2],
I explored how a unified CDM solution speeds up study commencement and supports efficient data consolidation, cleaning and analysis. In this third part I’ll explore how such a solution reduces both clinical trial supply fees and resource requirements for database lock without the time delays and costs of integration.
Clinical trial managers are faced with a perpetual conundrum with regard to clinical trial supplies. Based upon country and site-specific subject recruitment estimates, they can either provide an overage of supplies or risk stockouts; both are costly options.
Overages of supplies, often in excess of 50%, mean that expensive trial medication, lab kits, giving sets, etc. are procured secure in the knowledge that this overage will not be used. In a late phase III or phase IV study, this may actually divert significant quantities of IMP from sales and, thus, an additional cost of lost sales is incurred.
An alternative is to provide minimal supplies and risk the delays and loss of eligible subjects associated with a stockout in the event that recruitment rates are higher than expected. Stockouts often require very expensive remedial actions to ensure that recruitment or treatment can restart.
To avoid these options, it’s critical that an RTSM solution with sophisticated randomization and resupply algorithms is fed with accurate subject recruitment and status data. This is only possible through tight integration with EDC. But such integrations are expensive and risky and, by definition, require additional time between final protocol and FPFV. A CDM solution with unified and powerful EDC and RTSM capabilities enables accurate supply and resupply triggers and tracking, maintenance of full, live drug accountability while eliminating the costs, risks and time delays of integration.
The immediate consolidation of data from ePRO and RTSM within EDC, especially when coupled with continuous integration of lab data and within system data cleaning, has a powerful impact on database lock. Since the bucket of clean, coded, analyzable data gradually fills up, analyses can be performed ad hoc to detect when a safety or efficacy endpoint is reached. If this occurs before 100% of subjects complete the study, it’s unethical to keep subjects on the study any longer. Not only that, but halting a study early has an obvious impact on reduced cost and accelerated clinical development.
Even if a study does conclude when a target number of subjects have completed all visits, since data cleaning and coding locking of datapoints has been ongoing since day 1, locking the database should rely on the locking of a small proportion of data. This can mean that database lock occurs within days rather than weeks of LPLV, again accelerating progress of the development program. Without unification, database lock is very often a frantic period of high-resource utilization; with unification, no additional resource should be required, thereby reducing cost even further.
By now, you should have a good idea of the enormous value and minimal cost of a unified EDC, ePRO and RTSM solution. To learn even more about how the dream is already a reality, please join us for a complimentary webcast on Wednesday, September 25 at 1:00PM EST.
Want a more in-depth look at this topic? Check out the paper Risk-Based Monitoring: How Tight, Bidirectional Integration between CTMS and EDC Makes Truly Intelligent Monitoring Possible.
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