Clinical Research Services is an essential shared resource that provides centralized, integrated, and coordinated support for cancer clinical trials conducted through Yale Cancer Center. Patients enrolled in cancer clinical trials are most frequently cared for at Smilow Cancer Hospital at Yale-New Haven and at the Smilow Cancer Hospital Care Centers throughout Connecticut. Yale Cancer Center’s clinical trial portfolio includes over 130 active trials, providing options beyond the standard of care for patients with most types of cancers. Each year, over 700 patients choose to participate in one of our clinical trials as part of their care plan developed by their physician.
The Clinical Research Services (CRS) is a Shared Resource comprised of the Clinical Trials Office and Office of Protocol Review and Monitoring, as well as resources for contracts and budgeting and protocol development. A Steering Committee, Protocol Review Committee, and Data Safety Monitoring Committee oversee all clinical trial activities for Yale Cancer Center, along with the Institutional Review Board (IRB) and Human Investigations Committee (HIC) at Yale School of Medicine.
This resource provides the infrastructure necessary to support translational research and high-quality clinical trials. The staff of research nurses, data managers and administrative assistants offers complete support for clinical trials, including: preparation and submission of protocols to review committees, filing of all regulatory documents, establishment and maintenance of research files, completion of Case Report Forms, design of data entry forms, medical record abstraction, preparation of reports and analysis, coordination of monitoring visits and audits, as well as patient education, monitoring and follow-up. The staff has expertise in coordinating industrial, cooperative group and Yale-initiated studies. The office is experienced in all phase studies of drug development and in coordination of multi-center studies.
Howard Hochster, MD, Director