Observational Oncology Study: An international, multicenter, prospective, cohort observational study to assess the incidence of chemotherapy-induced diarrhea in colorectal and breast cancer patients

Client: Pharmaceutical company

Client/study focus and needs: The primary aim of this international, multi-site, multi-country observational/non-intervention study is to evaluate prospectively, in routine medical practice, the incidence of chemotherapy-induced diarrhea (CID) episodes occurring in breast and colorectal cancer patients. We are responsible for the 22 U.S. sites, including site management, regulatory submissions, data management activities, and site monitoring. In addition to the United States, seven other countries are participating, with the goal of enrolling 2,000 participants.

Our customized approach: We applied our standard operating procedures for managing observational studies, including the selection of 22 oncology centers to establish clinical study agreements that govern the operations of the study. We trained sites on the study protocol, electronic data capture, and study operations. The collection of daily patient diaries is an essential part of the observational study, and we implemented standard procedures for the distribution, tracking, and receipt of the hard-copy diaries. We held regular teleconferences with the sites and the client to ensure that study activities were streamlined.

Services: Clinical study support, eClinical systems support, data management

Results: We successfully launched the observational study to enroll patients at all active clinical sites in the U.S., including obtaining authorization for institutional review board (IRB) approval (using a hybrid of central and local IRBs). At the end of active enrollment, the sites will have obtained detailed data on the impacts of CID in thousands of patients around the world.