Applied Clinical Trials
A recent study conducted by the Tufts Center for the Study of Drug Development (Tufts CSDD) found that more than half of all protocols require one or more amendments.
A recent study conducted by the Tufts Center for the Study of Drug Development (Tufts CSDD) found that more than half of all protocols require one or more amendments. Based on data from 3,410 protocols provided by 17 large and midsize pharmaceutical and biotechnology companies, Tufts CSDD found that completed protocols across all phases had an average of 2.5 amendments requiring 6.9 changes to the protocol per amendment. Later-stage Phase II and III protocols had a higher average number of amendments, 2.7 and 3.5 respectively. The most commonly cited causes of amendments included the availability of new safety information, requests from regulatory agencies to amend the study, and changes in the study strategy. Protocol design flaws and difficulties recruiting study volunteers were also cited as top causes. The study found that the incidence of amendments is associated with protocol complexity and duration. The mean number of amendments per protocol, for example, was positively and significantly correlated (p<.001) with the number of procedures per protocol, study length, and the number of investigative sites conducting that protocol.
—Tufts Center for the Study of Drug Development, http://csdd.tufts.edu.
Mean number of amendments per protocol. (Source: Tufts Center for the Study of Drug Development)
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.