Applied Clinical Trials
Tufts CSDD
Clinical grants are growing increasingly sophisticated. Consquently, investigator site startup costs have become increasingly complex as well. Clinical sites are charging for a greater amount of site-cost line items. In addition, sites are charging more for those line items.
TTC's GrantPlan database contains grants from 76% of global clinical trials. GrantPlan tracks all the site-cost line items from clinical grants. The most common site costs are general site startup administrative fees, advertising, IRB fees, and pharmacy fees.
In 2010 the average number of line items included in global clinical grant site costs was 2.9 line items. That number increased to 3.0 in 2011, and is currently approaching 3.1 line items in 2012. Advertising fees are most responsible for the additional line items.
Additionally, sites are charging more for individual line items. The single most common site cost is the general administrative site startup fee. Between 2010 and 2011 the average site startup administrative fee increased 8%. Halfway through 2012, the average startup administrative fee has increased 3%.
—TTC (for more information, please contact help@ttc-llc.com)
Using Patient Reported Outcomes in Dermatology Trials
April 25th 2024In part 3 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA sheds light on the unique challenges of dermatology trials and how clinical outcome assessments can be implemented in them.
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.