Unnecessary clinical trials cost pharma industry up to US $5 billion a year

Hannah Blake

pharmaphorum

Clinical trials are increasing in complexity, cost and difficulty to execute every year, and life science organisations are under growing pressure to identify opportunities in which to safely improve research and development efficiencies as well as reduce costs.

The Center for the Study of Drug Development (CSDD) at Tufts University School of Medicine recently found that clinical data, gathered from a quarter of the procedures administered to patients, may be unnecessary. Clinical trial procedures that do not directly support study endpoints or FDA safety objectives are considered ‘non-core procedures’.

In total, these unneeded procedures are responsible for up to US $ 5 billion in overall clinical trials costs per year and roughly 20% of a clinical trial’s budget.

“This study is groundbreaking in that it links, for the first time, clinical trial economics to protocol complexity. 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.”

Ken Getz, senior research fellow and research assistant professor at CSDD.

As an example of a ‘non-core procedure’, Tufts identified amendments made to protocols as a problem area, because each amendment adds 61 days and costs over US $450,000 to implement. Overall, Tufts found that in Phase 1 clinical trials, there were approximately 6.9 amendments to each protocol and that 18% of amendments were completely avoidable due to inconsistencies / errors in protocols or flaws in protocol design.