A Biostatistical Monitoring Committee was established to review periodically the procedures and performance of the data coordinating center of the National Cooperative Gallstone Study. The functions of this committee, the types of data coordinating center activities reviewed, the manner in which monitoring of these activities was carried out, and an assessment of the value of this committee to the study are discussed in this article.
Bibliographical noteFunding Information:
Although the BMC was not responsible for overseeing the DCC budget, it was asked periodically to review the DCC budget and its justification. This was an important role since other elements of the study organization did not have the expertise to critically review these financial considerations. This was also important to the DCC since reasonable bugetary requests were supported and thereby given greater credence by the study organization and the NIH.
The NCGS was a double-masked, randomized clinical trial to assess the efficacy and safety of chenodiol administered for 2 years to patients at ten TCs for dissolution of gallstones \[1\]B. esides the ten TCs and the Biostatistical Support Unit or DCC located at George Washington University, Bethesda, MD, the study group included a clinical coordinating center (CCC; Cedars-Sinai Medical Center, Los Angeles, CA) and five central laboratories. The study was funded by a prime contract from NIADDK to the CCC, and the DCC and other central units were funded by subcontracts from the CCC.
- clinical trials
- data coordinating center