It might not come as too much of a surprise to those working in clinical trials, but a new study confirms what many have probably already suspected: studies are becoming increasingly complex.
The increasing complexity of cancer clinical trials – including the use of more complex scientific designs, wider global scope, and a greater focus on highly targeted patient subpopulations – has exacerbated the challenges of conducting these studies, a newly completed analysis by the Tufts Center for the Study of Drug Development (CSDD) concludes.
“Oncology is the fastest growing and most active area of drug development, which has led to more [new product] Approvals, ”said Ken Getz, professor and director of Tufts CSDD who oversaw the study. “However, the large and growing number of oncology drugs that are in the pipeline and entering the marketplace carries the significant risk and execution challenges associated with the development of cancer therapy and which are likely to exacerbate. “
According to Tufts CSDD, the number of cancer-targeted trial treatments nearly quadrupled from 421 to 1,489 between 2000 and 2020. At the same time, Phase II and III oncology trials typically include more sites in more countries than trials of other drugs, making it harder to find patients to compete for and enroll in.
“The good news is that oncology drug reviews are on average two and a half months shorter than other drugs,” Getz said, noting that oncology drug reviews are more than twice as likely to have priority review in the US status.
The evolving state of conducting clinical trials: pilot or permanent?
On May 20, join Getz during ACRP 2021 as he examines the operating environment for clinical trials before and during the pandemic. Based on past and current research on industry practices and evolving patient preferences, this session will explore solutions to pandemic responses that are highest and lowest likely to become standard practice.
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Study results, highlighted in May / June Tufts CSDD Impact Report, also found:
- Oncology drug clinical trial duration is 30% to 40% longer than other drug trials due to the more complex designs and the difficulty of finding, enrolling, and retaining volunteer students.
- Screening and treatment duration are much longer in Phase II and III oncology trials compared to other drug trials, but the mean trial start times are shorter in Phase III.
- Oncology studies generate a much higher volume of data compared to other drug studies, especially in phase II protocols.
- Phase II and III oncology studies show larger protocol deviations and lead to more significant protocol changes compared to studies with other drugs.
Edited by Michael Causey