Applied Clinical Trials
Medidata Solutions
Site performance is a critical factor in the success of any clinical trial. Sponsors are continually looking for ways to better track site performance and minimize the number of sites that fail to enroll a patient. To that end, Medidata has tracked two metrics related to the performance of investigative sites, the percentages of both non-enrolling and high-enrolling sites. A non-enrolling site is a site that actively participated in a clinical trial but failed to recruit any patients.
Nearly one-third of sites performing clinical trials never enroll a single patient.
Non-enrolling sites contribute significantly to both study delays and unnecessary costs. Drawn from the more than 2,000 studies in the Medidata InsightsTM metric warehouse, the non-enrolling site performance metric shown in the graph illustrates that nearly one-third of sites performing clinical trials never enroll a single patient. While Asia Pacific is clearly the best performing geographic region at just more than 17%, in certain geographies the percentage is over 40%.
At tens of thousands of dollars in site initiation and maintenance costs per site, wouldn't it be nice to be able to eliminate or at least reduce the number of non-productive sites? What can be done to drive better site selection and performance? We'd love to hear your take on these results.
Please continue to stay tuned as we look further into Insights data throughout 2012.
—Medidata Solutions, www.mdsol.com
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.
FDA Grants Ziftomenib with Breakthrough Therapy Designation for NPM1-Mutant Acute Myeloid Leukemia
April 23rd 2024Data from the Phase Ib portion of the KOMET-001 trial showed that the once-daily oral treatment may provide a substantial improvement over available therapies for relapsed/refractory NPM1-mutant acute myeloid leukemia.