By Cyndi Root
According to a new KMR Group report, oncology trials are now taking longer to complete. KMR announced its findings in a press release, stating that late-stage oncology cycle times have increased in the last 10 years. Analysts assessed 4,100 trials from 32 companies to determine the trends in cycle times and defined trial duration as the time from Protocol Approval to Database Lock. Late-stage oncology (Phase 2 and 3) trials have seen significant increases in time duration. Compared to a decade ago, Phase 2 trials are taking a year longer and Phase 3 trials are taking up to a year and a half longer. The study found that operational aspects such as enrolling and treating have expanded by six months.
KMR Group’s extensive analysis on the oncology cycle times point to several reasons for the trend, especially in Phases 2 and 3. The significant shift has occurred due to oncology’s specific considerations, including oncology protocol complexity, biomarker search, and longer treatments, among other factors. In many trials, issues such as multiple endpoints, multiple diseases, and the increasing number of subjects play a part.
Authors state that while these reasons have merit, they are not the only explanations for the longer cycle times. Companies are handling trials differently in an intra-company manner that adds variability when defining an average time among companies over the years. Additionally, the way different companies handle trial processes makes a difference in the total trial time.
These operational processes provide an opportunity for companies to improve and decrease trial times. Refining the operational aspects of running clinical trials could have a substantial effect, the report authors say. In assessing operational aspects, oncology site selection, site initiation, and study startup can be improved as can oversight of facility performance.
The report highlights several improvements that industry can begin making in order to make oncology trials more efficient. Linda Martin of KMR Group, said, “The focus of these efforts is to optimize the enrollment process, with a goal of reducing cycle times and faster time to market.”