About the Clinical Trials Office
At VCU Massey, clinical research is a critical component of our scientific agenda and enables our teams to provide the latest cancer advances for our patients.
The Clinical Trials Office (CTO) supports investigators conducting cancer-focused clinical, translational and population science research at Massey, including industry-sponsored studies and investigator-initiative trials (IITs). Through the services listed below, CTO leadership and staff promote the conduct of high-quality human subject research and facilitate the development and activation of hundreds of cancer-related studies each year.
Our commitment to clinical research extends well beyond the greater Richmond area. Through our extensive clinical trials network, Massey is bringing cutting-edge advancements to the most rural corners of the commonwealth.
Clinical Trials at Massey
Find a Clinical Trial
Massey’s portfolio of 150+ cancer clinical studies offers patients access to the latest clinical advancements across the commonwealth.
Clinical Research Committees
Four committees ensure the safety, compliance and efficiency of clinical research activities and CTO operations.
NCI Networks
As an NCI-designated Comprehensive Cancer Center, Massey collaborates with several NCI Networks to increase access to studies.
Oversight & Services
The clinical operations team provides high-quality services and expert resources that enable and promote the conduct of efficient, high-quality clinical research throughout a study’s lifecycle – from study activation to close out.
Clinical operations also provide disease working group (DWG) support, study initiation oversight, patient screening, eligibility confirmation and enrollment, protocol activity management, study data collection, clinical research sample processing and preparation, and collaboration with all patient care teams to ensure study parameters are met.
Regulatory services are available to provide new trial feasibility review management, study activation coordination, Investigational New Drug (IND) and Investigational Device Exemption (IDE) application preparation and submission, and overall management of regulatory activities through the lifecycle of a study.
The research finance team assists with both pre- and post-award activities pertaining to clinical research efforts. This includes OnCore study calendar creation, coverage analysis, study budget and contract review, clinical research charge review and payment reconciliation.
Clinical research activities are organized across 15 multidisciplinary disease working groups (DWGs) spanning various cancer types and study types. Each group is responsible for reviewing new study concepts and emerging clinical trial protocols to ensure alignment with Massey’s patient population, evaluate scientific progress and enable operational feasibility.
DWGs are co-led by clinical cancer investigators with complimentary expertise, and includes representation from medical, surgical and radiation oncologists, oncology nurses and CTO staff. Active DWGs include:
- Acute Leukemia/Myeloid Malignancies
- BMT/Cellular Immunotherapeutics
- Breast
- Cutaneous/Melanoma
- Early Phase
- Gastrointestinal Oncology
- Gynecologic Oncology
- Head and Neck
- Lung
- Lymphoma/Myeloma
- Neurology-Oncology
- Pediatric Oncology
- Sarcoma
- Urologic Oncology
- Cancer Prevention and Control
DWGs are evaluated annually by the Clinical Research Leadership Committee to review their productivity, leadership and trial portfolio alignment with Massey research goals.
Massey’s Investigator-initiated trial research operations (IITRO) unit supports the identification and development of investigator-initiated trials (IITs). IITRO connects Massey investigators with knowledgeable, experienced staff to assist with protocol development and writing for new IIT concepts, database and electronic case report form development, trial activation, and study close out and manuscript development. This team also supports the preparation and management of Investigational New Drug (IND) and Investigational Drug Exemption (IDE) applications as well as safety and annual reporting to the U.S. Food & Drug Administration (FDA).
All IITs are also independently monitored for quality assurance and compliance under Massey’s Data & Safety Monitoring Committee.
Provider Profile: Keri Maher, DO
As the medical director of the Massey Clinical Trials Office, Maher ensures that clinical trials are a part of a treatment to improve cancer outcomes.
"Without clinical trials, we don't improve cancer outcomes and they stay the same."