The results of a new research study performed by the Center for the Study of Drug Development at Tufts University School of Medicine and sponsored by Medidata Solutions, a global provider of cloud-based clinical development solutions, found that clinical data gathered from 25% of the procedures administered to patients may be unnecessary—and, in the aggregate, are responsible for $3-5 billion in overall clinical trial costs annually.
With clinical trials increasing in complexity, cost and difficulty to execute, life science organizations are under growing pressure to identify opportunities to reduce costs and safely improve R&D efficiencies. Procedures identified as non-core to the protocol may represent opportunities for pharmaceutical companies to streamline their trials and significantly reduce clinical trial budgets.
The study was conducted over an eight month period and is based on data from 15 international sponsor companies of all sizes. Study participants and the research team used a version of Medidata Designer customized for the research study to collect and analyze more than 115 clinical trial protocols and categorize more than 22,000 medical procedures. The costs of “core” procedures—those supporting study end-points or safety objectives—and “non-core” procedures were measured using Medidata’s extensive benchmarked clinical trial cost database.
“This study is groundbreaking in that it links, for the first time, clinical trial economics to protocol complexity,” said Ken Getz, senior research fellow and the study’s principal investigator. “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.”
Key study findings include:
- Approximately 25% of all clinical trial procedures are considered non-core, i.e. are not directly tied to the trial end-points as agreed upon prior to the study by the FDA for demonstrating the safety and efficacy of the drug or therapy in question.
- The non-core procedures represent roughly 20% of a clinical trial’s budget—an estimated $1 million in non-core procedure costs per clinical study.
- Considering the number of studies conducted annually, physician-related costs associated with non-core procedures total $2-4 billion a year across the industry.
- These procedures also increase the total burden of the clinical trial, requiring data management, monitoring, statistical analysis etc. Including these related trial costs, the non-core procedures represent an estimated $3-5 billion each year.
Marla Curran, director of clinical statistics and doctor of public health in biostatistics at GlaxoSmithKline (GSK), was part of the study working group and has driven efforts to increase efficiency across GSK trials. She views the study as one of the first to reveal actionable ways to cut clinical development costs without sacrificing safety or quality.
“By distinguishing between core and non-core procedures early on in the trial process, this research underscores the critical roles study design and protocol development play in overall clinical trial costs,” said Curran. “Even with this study’s conservative estimate of the procedures organizations could potentially eliminate, it’s clear that the industry can take a closer look at trial design to improve efficiencies while still meeting regulatory requirements.”
Medidata Designer was key to the Tufts CSDD team’s ability to collect information for the study, as it is the only tool to offer clinical trial sponsors visibility into cost and complexity metrics, as well as the structuring capabilities crucial for identifying unnecessary procedures during the study design stage.
“For years, we have been emphasizing that the effectiveness of any trial starts with a strong study design,” said Glen de Vries, president of Medidata Solutions. “Through the use of Designer, this study emphasizes the increasing role technology, and the expertise around it, will continue to play in helping drug developers design, conduct and manage efficient and effective clinical trials.”