Applied Clinical Trials
Protocol complexity, as measured by the number of unique procedures and their frequency and the number of subject eligibility criteria, has risen dramatically in comparisons of protocol characteristics between two time periods, 2000-2003 and 2004-2007.
Protocol complexity, as measured by the number of unique procedures and their frequency and the number of subject eligibility criteria, has risen dramatically in comparisons of protocol characteristics between two time periods, 2000-2003 and 2004-2007. The burden on investigative sites to administer these procedures has also risen sharply. Tufts CSDD research has shown that higher levels of protocol complexity and execution burden are associated with study conduct delays, longer cycle times, more protocol amendments, and poorer patient recruitment and retention rates. Phase I and Phase IV protocols have seen the largest increases in complexity and work burden as drug developers have sought to gather more clinical research data in earlier phase clinical trials and as post-approval clinical research studies have become more robust. Phase III protocols grew the least in terms of complexity and execution burden during the observation period perhaps reflecting sponsors' efforts over the last decade to control rising costs and demands of large, later-stage clinical research programs.
—Tufts Center for the Study of Drug Development, http://csdd.tufts.edu.
Rising Protocol Complexity and Execution Burden
Regulatory Compliance With eCOAs
April 26th 2024In the fourth and final part of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA discusses how the regulatory stance on electronic clinical outcome assessments has changed over the years and what it could look like in the future.
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.