Applied Clinical Trials
Tufts CSDD
A 2012 study conducted by the Tufts Center for the Study of Drug Development shows that academic centers and hospitals take significantly longer to initiate industry-funded clinical trials. Overall, it takes an AMC or hospital more than one year (12.9 months) on average from the pre-study visit to first patient in (FPI) the clinical trial. This compares with 7.9 months for community-based physician practices to complete the same cycle—nearly a 40% time reduction. The Tufts CSDD study evaluated start-up cycle times for 5,296 investigative sites participating in 105 Phase II and III clinical trials. The largest bottleneck is the time from when the contract is received by the center to the time that the contract is executed. AMCs and hospitals take nearly 73% longer than their for-profit counterparts—4.1 months on average versus 1.1 months. Cycle times from contract execution to site initiation, and from site initiation to FPI for non- and for-profit investigative sites are much closer, suggesting that AMCs and hospitals perform more competitively once they get through their less efficient administrative tasks.
Figure 1
—Tufts Center for the Study of Drug Development, https://csdd.tufts.edu
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.