The Division of Cancer Treatment and Diagnosis (DCTD) of the National Cancer Institute (NCI), has the scientific mission, the organizational scope, and the obligation to oversee the research directions of clinical cancer treatment. Among its responsibilities, the DCTD is the sponsor of Investigational New Drug Applications (IND) for new anticancer agents and Biological Response Modifiers. For every trial utilizing NCI-sponsored investigational drugs, a protocol outlining the study plan, criteria for patient eligibility, and definitions for toxicity and response is submitted to DCTD. Protocols are reviewed and approved by the CTEP Protocol Review Committee. Upon final approval they are filed with the FDA.

As an IND sponsor, the DCTD is obligated to monitor clinical trials to assure high quality data. This obligation is described in the Code of Federal Regulations pertaining to the FDA. In view of this, and in light of the practice of clinical trials in the 1970’s, the DCTD determined that a Clinical Trials Monitoring Service (CTMS) was needed, with resources dedicated to monitoring the studies it was sponsoring. CTMS was launched in 1979 by a contract to an organization which in 1982 became Theradex Systems, Inc., of Princeton, New Jersey.

The first objective was to establish a detailed patient database for clinical observations occurring during Phase I trials in order to provide regular status reports and summary findings in a uniform format. To do this, data regarding all patients treated on Phase I clinical trials sponsored by the DCTD and assigned to the CTMS for monitoring have been captured into a central CTMS database. Monthly reports consisting both of summaries per study and per drug, as well as single patient data have been made available to the DCTD staff. Quarterly, study summary and single-patient data have been made available by the CTMS to each investigator.

The second original objective of CTMS was to provide an on site monitoring service for each Phase I institution; this was initially provided on an annual basis and more recently three times a year. By on-site monitoring of Phase I investigators, CTMS assures the DCTD of the compliance of investigators with NCI policies and FDA regulations regarding data quality, patient rights protection, investigational agent storage and accountability, etc.

In addition to the Phase I studies, the DCTD also has the obligation to closely monitor all other investigational drug trials conducted under DCTD sponsored INDs. Therefore all investigators conducting such studies must be periodically monitored on site. Since Phase II and III trials are inherently safer for the patient, these studies are monitored less frequently, using a spot-check technique.

Currently, all the Cooperative Groups funded by DCTD are actively monitoring their member institutions, affiliates, and CCOPs for protocol compliance, using mutually-agreed elements and mechanisms. Since 1982, CTMS has represented DCTD in this monitoring at two levels: 1) participating in co-site visits with cooperative group monitoring programs; and 2) organizing and supporting an on-site monitoring program for other investigators conducting studies with DCTD-sponsored investigational agents.