Abstract
IntroductionMost of clinical laboratories are not properly reimbursed for their activity related to clinical trials (CTs) conducted in their institutions due to a lack of measurement strategies. We implemented a specific computer physician order entry (CPOE) environment for CTs in order to facilitate ordering to providers and estimate the associated costs to be compared with the standard of care (SOC).Materials and methodsFour specific electronic formularies, restricted to two new virtual CTs clinical services (onco - CT and haemo - CT), were implemented in January 2015. For each clinical trial displayed in the panels there were several box-cells that contained several profiles based on the different phase of the trials. Tests included in the profiles were the tests required by protocol. Laboratory costs (€) per patient were compared between the CTs services and their regular outpatients clinical services (onco - Out and haemo - Out, considered the SOC) for three years.ResultsCosts per patient were higher for CTs services and increased progressively each year (25%, 70% and 70% and 0.6%, 2.7% and 17% in 2015, 2016 and 2017 for Oncology and Haematology, respectively). Taking into account all these differences and the number of patients attending a total difference in expense of + 130,377.7 € for the period 2015-2017 was obtained between CTs and outpatients services.ConclusionsStrategies through CPOE systems based on restricted and specific profiles for CTs ordering are a promising tool that can improve laboratory associated costs estimation and provide robust evidence in reimbursement negotiation processes with CTs sponsors.
Highlights
Most of clinical laboratories are not properly reimbursed for their activity related to clinical trials (CTs) conducted in their institutions due to a lack of measurement strategies
Costs per patient were higher for CTs services and increased progressively each year (25%, 70% and 70% and 0.6%, 2.7% and 17% in 2015, 2016 and 2017 for Oncology and Haematology, respectively)
Taking into account all these differences and the number of patients attending a total difference in expense of + 130,377.7 € for the period 2015-2017 was obtained between CTs and outpatients services
Summary
Most of clinical laboratories are not properly reimbursed for their activity related to clinical trials (CTs) conducted in their institutions due to a lack of measurement strategies. In patients with cancer they play a pivotal role in improving their care from a therapeutic point of view but from a palliative perspective as well. Their management has experienced an increase in their complexity and, more importantly, in their costs over and above SOC (2). Service support costs represent the ancillary patient care costs related to the research itself, which would finish once the clinical trial stops, even supposing the patient care continues to be dispensed In this element additional investigations like imaging and laboratory tests are included as long as they would not continue to be supplied when trial stopped but patient care service continued to be provided
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