Clinical trial sponsors are spending US$3-5 billion a year in aggregate on medical procedures that may be surplus to requirements, a new study has found.
In the study presented by principal investigator Ken Getz at the 48th Annual Meeting of the Drug Information Association, researchers from Tufts University School of Medicine used a customised version of Medidata Designer, an eClinical tool for protocol development, to collect and analyse over 115 trial protocols from 15 international sponsor companies and to categorise more than 22,000 medical procedures administered to patients during those trials.
The study, which was conducted over an eight-month period, was sponsored by Medidata Solutions, the US-based provider of cloud-based clinical development platforms to enhance the efficiency of clinical trials.
Medidata’s extensive database of benchmarked clinical-trial costs also enabled the Tufts University researchers to measure the financial impact of ‘core’ procedures – those supporting study endpoints or safety objectives – and of ‘non-core’ procedures.
The context for the study was growing pressure on lifescience organisations to identify opportunities to reduce costs and improve R&D efficiencies without compromising safety, as clinical trials become increasingly complex, expensive and hard to execute.
Among the key findings were:
• Around 25% of all clinical trial procedures were considered non-core – in other words, they were not directly tied to the trial endpoints agreed prior to the study by the US Food and Drug Administration for the purpose of demonstrating the safety and efficacy of the drug/therapy in question.
• These non-core procedures accounted for roughly 20% of the clinical-trial budget – an estimated US$1 million in non-core procedure costs per study.
• Considering the number of studies conducted annually, physician-related costs associated with non-core procedures came to US$2-4 billion a year across the industry.
• Non-core procedures also increased the overall burden of the clinical trial, requiring data management, monitoring, statistical analysis etc. If these related trial costs were factored in, non-core procedures represented an estimated annual spend of US$3-5 billion.
Eye-opening results
“This study is groundbreaking in that it links, for the first time, clinical trial economics to protocol complexity,” commented Getz, senior research fellow and research assistant professor at Tufts University’s Center for the Study of Drug Development.
“The results have been eye-opening for participating companies and will no doubt serve as a jumping-off point for pharmaceutical and biotechnology companies to examine ways to reduce the number of non-core procedures to improve clinical trial efficiency and substantially reduce study budgets,” he added.
Marla Curran, director of clinical statistics and doctor of public health in biostatistics at GlaxoSmithKline, regards the study as one of the first to highlight viable ways of cutting clinical-development costs without sacrificing safety or quality.
