Applied Clinical Trials
Trend doesn't seem to fall in line with the perception of an increasingly complex trial protocol climate.
Are pharmaceutical company Phase III clinical trials becoming more complex? The most broadly based database available, ClinicalTrials.gov, does not support the assertion that clinical trials have become more complex in study/protocol design or execution. Illustrative is the number of countries used in pharmaceutical company sponsored Phase III clinical studies.
The number of countries used in commercially sponsored Phase III trials has not changed in recent years. It is essential to stratify the results or otherwise the data appear to show that the number of countries per study has actually declined. The chart at right stratifies the studies by planned study duration: less than one year, 1 to 2 years and 3 or more years. This is important because the longer the planned study, the more likely the study may be opening sites in additional countries. When stratified this way, the data show practically no change over the years covered.
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.