Oncology trends: smaller indications and greater efficiency, says QuintilesIMS Institute
The number of patients enrolled in Phase III clinical trials declined from a high of 671 in 1998 to 188 patients in 2016, according to a report published by the QuintilesIMS Institute.
Additionally, trial duration declined from 2,000 days in 1997 to 1,070 in 2016.
As Michael Kleinrock, research director of the QuintilesIMS Institute explained, these numbers could indicate two things: that companies are targeting smaller indications and/or that companies are becoming more efficient at completing trials and thus, are doing so at a reduced cost.
“Both are good things for those companies and for patients who get drugs sooner,” he told Outsourcing-Pharma.com.
“Trial designs that shift to having fewer measured end-points are ultimately simpler to complete faster,” Kleinrock added. “Smaller indications may ultimately be rarer cancers, but since most of the large tumors have effective treatments, this is only natural.”
The report also notes that clinical trial sponsors are employing improved trial design technologies to accelerate drug development. This includes the use of predictive biomarkers to target sub-populations within cancer types.
“Those that are in R&D have been facing ever greater pressures to optimize R&D for time and cost and to get to market faster and at lower development cost,” Kleinrock said.
As Outsourcing-Pharma.com previously reported, biomarker-enabled drug programs are three times more likely to reach approval.
Ultimately, Kleinrock explained the key finding was that there are more, better cancer drugs on the market than ever before – and more are coming.
