NCI - CTMS | Partners since
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.
CTEP Help Desk
CTEP Help Desk
For information about the NCI DCTD Clinical Trials Therapy Program, please visit
the CTEP website or email the CTEP help desk.