Skyrocketing Clinical Trial Costs Ding Sponsor ROI

Rising Costs

Clinical Trial Costs Nearly Doubled Since 2010, Report Says

The sometimes-fragile relationship between sponsors and contract research organizations (CROs) probably won’t be helped by alarming new data suggesting clinical trial costs have nearly doubled since 2010, according to Deloitte’s 8th annual report, “A New Future for R&D?” Worse still, trial costs have grown in six of the past eight years.

In the report, Deloitte estimated the sponsors’ internal rate of return (IRR) return based on research and development (R&D) spending on the products sponsors hope to launch through 2022.

In 2017, it cost an average of nearly $2 billion for a top 12 pharma company to get a new drug to market. That’s a big jump from 2016, when the cost was $1.5 billion. In 2010, the cost was $1.2 billion.

While the report lays much of the blame for the declining IRR numbers on clinical trial–related problems such as low adherence rates, it did offer some room for optimism. Deloitte called out several encouraging developments, including:

  • Harnessing real-world evidence (RWE) to improve R&D productivity. RWE could “reduce the time it takes to recruit patients, identify subpopulations, and to conduct research, and in many cases, it could make drug development and approvals more efficient.” The report also cited advances in centralized and real-time clinical trial monitoring as a suite of tools and tactics to help better “analyze large amounts of operational data from historical cases, predict performance of different clinical trial sites, and use predictive criteria to determine drug outcomes, drop-out rates, and success rates of trials.”
  • Leveraging artificial intelligence (AI) to improve study design and decision-making by better navigating large datasets. “Once patients are recruited, [AI] can boost enrollment by studying why patients accept or decline invitations to relevant studies,” according to Deloitte. It can identify the drivers of value in patient engagement and better “curate” the patient experience.
  • Robotic and cognitive automation can increase efficiency and accuracy of repetitive tasks. Automation of certain aspects of the clinical trial process could free up program teams to focus on critical path activities or to accomplish tasks that were previously considered too time consuming or costly.

The report also noted the commitment by the U.S. Food and Drug Administration (FDA) to promote use of advanced technologies in clinical trials. “The FDA has been outspoken about its desire to evaluate innovation in clinical trials,” the report said.

Author: Michael Causey