DF/HCC has one of the largest clinical research initiatives in the country, taking a unified approach to approving,
activating, monitoring, and supporting the cancer-related clinical trials conducted at our member institutions. As
an NCI-designated Comprehensive Cancer Center, clinical trials efforts must comply with federal guidelines for
cancer-related clinical trials.
What types of studies must be reviewed through DF/HCC?
Ancillary: Auxiliary studies that are stimulated by, but not Observational: Prospective studies for a defined popula-
a required part of, a main clinical trial/study, utilize patient tion to assess changes in the status of the participants.
or other resources of the main trial to generate information
Outcomes: Studies of a defined population to assess the
relevant to it, and are linked to individual patients or partici-
outcome of some kind of treatment or behavioral interven-
tion NOT part of the study.
Correlative: Laboratory-based studies using specimens to
Prevention Trials: Trials in which an agent or other in-
assess cancer risk, clinical outcomes, response to therapies,
tervention is used for the primary prevention of cancer in
etc., that are linked to individual patient or participant data.
healthy subjects as well as high-risk subjects.
Diagnostic: Trials testing the efficacy of devices, tech-
Screening: Trials using the full population to test the ef-
niques, procedures or tests to diagnose disease usually
ficacy of devices, techniques, or tests for earlier or more
leading to a treatment decision.
accurate detection of disease.
Early Detection: Trials using a select population to test the
Supportive Care: Trials using an agent or other interven-
efficacy of devices, techniques, or tests for earlier or more
tion to improve the quality of life of the subject.
accurate detection of disease.
Therapeutic Trials: Trials using an agent or other interven-
Epidemiologic: Studies among cancer patients and/or
tion with the intention to cure cancer or to prolong the life
health populations to determine the patterns, causes, and/
of the patient and studies for secondary prevention follow-
or control of disease leading to improved understanding of
ing curative therapy.
screening and detection, diagnosis, and treatment of cancer.
Clinical Trials Process
The scientific review of clinical trials at DF/HCC is designed to ensure that activated trials are of high scientific merit, a prior-
ity to the relevant disease program, and will accrue the targeted number of research subjects.
Prior to formally submitting a trial for review and approval, there is an extensive and interactive vetting process. This
includes review of the trial concept and draft protocol at the institutional level as well as by the relevant DF/HCC research
program. While the review process may vary depending on the
research program, no protocol is forwarded for scientific review un-
less the protocol packet includes a signed letter of support by the Clinical Investigator Toolkit
Program Leader that confirms the trial is of scientific importance,
does not overlap with existing trials, and can be completed within This onlilne Toolkit provides standardized tools
the desired time frame. to create protocols, IND applications, and multi-
Submitted trials are reviewed by the Scientific Review Commit-
tee (SRC), as well as several specialty subgroups such as radia- www.dfhcc.harvard.edu/toolkit
tion safety, research pharmacy, nursing, and biostatistics. Once
approved by the SRC, the Institutional Review Board (or IRB)—a
single review board for all cancer-relevant research as required by the NCI for all Comprehensive Cancer Centers, and
consisting of multiple panels to support the large number and diversity of trials taking place at DF/HCC—conducts its initial
review. When approved by the IRB, the trial is activated. Activated trials are reviewed annually on the basis of scientific
merit and accrual rate.
The DF/HCC web site has a wealth of information and resources about clinical research. Forms, information, updates,
and toolkits are available. For more information please go to: www.dfhcc.harvard.edu/clinical-research-support/
Clinical Research (cont’d)
Clinical Research Support Offices
Clinical Research Agreements Office Office for Human Research Studies (OHRS)
The Clinical Research Agreements Office works with OHRS coordinates all SRC and IRB committees, and pro-
industry to negotiate budgets and contracts for PI-initiated vides regulatory guidance and resources to clinical investi-
trials. For CHB and BIDMC-led trials, the Office works gators and their support staff. The office also maintains the
closely with clinical trials negotiators at their respective Oncology Protocol System with current copies of protocol
institutions. and consent documents.
Clinical Trials Education Office (CTEO) Quality Assurance Office for Clinical Trials (QACT)
CTEO sponsors a full range of educational programs for QACT is responsible for registering human subjects for
investigators, nurses, coordinators, and other support trials. They ensure high-quality standards are used for data
staff focusing on clinical trials issues. CTEO also oversees collection and the ongoing management of clinical trials,
human subject protection training for DF/HCC research including computerization of protocol data, auditing, and
personnel, which is required every three years, and regis- data safety monitoring. QACT also coordinates quality as-
tration of new protocols through clinicaltrials.gov. surance efforts related to multi-center clinical research.
To find a list of active clinical trials at DF/HCC and across the nation, visit the web site,
www.dfhcc.harvard.edu, and go to the Visitor Center/Clinical Trials.
Clinical Trials Operations Clinical Trials Education Office
Jeffrey Clark, MD Michele Copersino, MPH, CCRP
(617) 643-3415 (617) 582-8422
Beverly Ginsburg-Cooper, MBA Office for Human Research Studies
(617) 632-4452 Michele Russell-Einhorn, JD
Beverly_Ginsburg-Cooper@dfci.harvard.edu (617) 632-3032
Clinical Research Agreements Office
Mary Melloni, RN, JD, MBA Quality Assurance Office for Clinical Trials
(617) 632-4192 Jane Russell
Mary_Melloni@dfci.harvard.edu (617) 632-3764
Dana-Farber/Harvard Cancer Center is the largest National Cancer Institute-designated Comprehensive Cancer
Center in the nation. Founded in 1998, DF/HCC is an inter-institutional research enterprise that unites all of the cancer
research efforts of the Harvard-affiliated community. The primary goal of the Cancer Center is to encourage and
promote collaborative interactions and translational research that will lead to new approaches to cancer prevention,
diagnosis, and treatment.