4 min read
How to Measure and Improve ROI in Clinical Research
Sophia Kapchinsky, PhD.
Feb 11, 2021 8:00:00 AM
Using a centralized database of de-identified electronic health records (EHR) can help clinical researchers determine study feasibility, expedite patient recruitment, reinforce grant applications, and avoid research dead-ends in a cost-effective manner.
Scientific Directors and Principal Investigators (PIs) need ways to quantify their return on investment (ROI) for clinical research in order to create budget predictions and show tangible benefits from their investments. This can be challenging since profits are linked to Key Performance Indicators (KPIs) such as a research footprint, number of studies successfully completed per budget allowance, time to publication and publication rates, H-index, securing funding, and notoriety within the research community. While the costs of research are not only financial, but are also related to resources, time, infrastructure, staff, etc.
Extensive research has shown that patient recruitment alone can have a significant impact on the bottom line of a research center.
What are the financial impacts of poor recruitment?
Despite new strategies in patient recruitment and study design and methodology cohort recruitment and retention continues to be a large struggle. In 2009, it was estimated that the economic impact of low-enrolling studies within a single medical center is nearly $1 million USD. This represents approximately $1.2 million USD or $1.6 million CAD in 2020 for a single research center. In addition, the 2020 January/February Tufts CSDD Impact Report showed that the average budget for patient recruitment is over $600,000 for late phase studies with each patient costing over $2,000.
According to the McDougall Scientific, Canada is home to approximately 5,500 active clinical trials. The trials take an average of half a year to recruit their first patient for Phase I studies, while Phase II, III, and IV studies take an average of 10 months. Globally, 11% of sites are unable to recruit a single patient.
When taking a closer look, 25% of clinical trials are terminated prematurely due to difficulties in recruitment; 50% are forced to extend their recruitment time to enroll enough patients; and a large number of studies fail to meet statistical power due to under-recruitment.
Studies have shown that patient recruitment not only exceeds planned timelines, it can also go significantly over budget by as much as 18x higher than the planned budget.
The long timelines and high costs caused by difficulties in identifying and recruiting patients creates a need for new innovative ways to streamline the patient recruitment process and positively impact their ROI.
Continuing to use traditional strategies for patient identification and recruitment will maintain the status quo. It will continue to yield financial losses, to foster uncertainty in recruitment success, and to create frustrations, while negatively impacting the research footprint and reputation of the respective research centers and labs.
Improving ROI and research footprint using new technology
Logibec NOAH aims to support clinical researchers with improving their ROI through increasing information and decision value, increasing research reputation and network, and decreasing time to action and infrastructure costs.
Bioinformatics tools and support platforms like Logibec NOAH ensure that research budgets, that are often limited, are not wasted on studies that result in minimal scientific benefit. New technologies that are supported by cloud computing, eliminate the need for in-house IT infrastructure, improve processing times and reduce down time, all of which can be very costly.
Researchers can have added assurance and confidence that they are investing their funds, time, energy, and ideas in studies that are likely to reach their end-point thanks to successful patient recruitment. What’s more, it aids discovery of new ideas and breakthroughs.