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.
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 priority 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 unless the protocol packet includes a signed letter of support by the Program Leader that confirms the trial is of scientific importance, does not overlap with existing trials, and can be completed within the desired time frame.
Submitted trials are reviewed by the Scientific Review Committee (SRC), as well as several specialty subgroups such as radiation 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 and diverse number 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.
Clinical Trials Operations
Jeffrey Clark, MD
Medical Director, Clinical Trials Operations, DF/HCC
Senior Vice President, Research Administration
Clinical Research Support Offices
Clinical Research Agreements Office
Mary Melloni, RN, JD, MBA
The Clinical Research Agreements Office works with industry to negotiate budgets and contracts for PI-initiated trials. For CHB and BIDMC-led trials, the Office works closely with clinical trials negotiators at their respective institutions.
Office for Human Research Studies (OHRS)
Michele Russell-Einhorn, JD
OHRS coordinates all SRC and IRB committees, and provides regulatory guidance and resources to clinical investigators and their support staff. The office also maintains the Oncology Protocol System with current copies of protocol and consent documents.
Quality Assurance Office for Clinical Trials (QACT)
QACT is central to the DF/HCC Data and Safety Monitoring Plan. This group is responsible for registering human subjects for trials, ensuring high-quality standards are used for data collection, and the ongoing management of clinical trials, auditing, and data and safety monitoring. QACT also coordinates quality assurance efforts related to multi-center clinical research, registration of new protocols through clinicaltrials.gov, and educational programs focused on clinical trials issues.
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.