A quarter of procedures carried out during clinical trials may be pointless according to a new study, which suggests that this unnecessary work costs around $5bn (€3.96bn) a year.
Carried out by Medidata and Tufts University School of Medicine, the report was based on eight months’ worth of data about 115 clinical trial protocols from 15 companies, including big international players like Lilly, Sanofi and GSK (GlaxoSmithKline).
The key finding is that procedures not supporting a study’s end-points or safety objectives – termed “non-core” dealings – are often unnecessary.
By simplifying the process and cutting non-core aspects, the investigators said, CROs (contract research organisations) and researchers could save themselves significant, and otherwise wasted, money.
Michelle Marlborough, director of product management at Medidata Solutions told Outsourcing-Pharma.com that though complexity in studies isn’t always a bad thing, companies often are not aware of the snowball affect their small decisions make.
She said: “In isolation the addition of a procedure may not seem like a big deal, but the cumulative effect of those decisions is clear to see in this study.”
Marlborough also said fear of the regulators plays a big part in the collection of too much data, adding: “There seems to be a fear in organisations of not having data if it is requested by the regulators, and so that drives a culture of collecting data 'just in case.’”
Principle investigator and Tufts senior research fellow Ken Getz said the study is the first of its kind to link trial economics to protocol complexity, adding: “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.”
Call for change
Marlborough told us the best way to take action is forward planning. She said that by setting more rigid design protocols, researchers will not stray away from the goal.
“There needs to be substantial changes in the way protocol design is conducted,” she said.
“Sponsors need to ensure that they can see the cost, complexity and purpose of procedures in a protocol aligned with the objectives of the study. Visibility of the purpose of the procedures will allow robust scientific challenge of protocol designs and allows sponsors to quantify the impact of decisions.”
She also said that simplifying the protocol was something that could benefit all of the companies surveyed – which also included Abbott, Bristol-Myers Squibb, AstraZeneca, and Amgen – adding “the issues were consistent across the data collected.”
“Sponsors we work with that are making head way are embracing technology to revolutionize the way they write protocols, the focus is shifting away from thinking about the document to ensuring the design is optimal, and the need for every procedure in a study is challenged and justified,” Marlborough added.