ClinicalTrials::Clinical Research Committees

Huntsman Cancer Institute Clinical Trials



	Before a clinical trial begins, there is an extensive review process to determine scientific merit and patient safety. Below is a list of committees that evaluate clinical trials before they open at Huntsman Cancer Institute (HCI). Clinical Research Executive Committee The Clinical Research Executive Committee (CREC), comprised of senior clinical research leaders at HCI, oversees and directs clinical research at HCI, including policy setting for the Clinical Cancer Investigations Committee (CCIC) and Data Safety Monitoring Committee (DSMC). It also establishes priorities for the Clinical Trials Office (CTO), reviews general accrual and resource allocation issues, and facilitates integration of research into the HCI multidisciplinary clinics. This committee reviews minority recruitment efforts and assists in the development of future plans to enhance patient accrual. CREC Members: Sean Mulvihill, MD, Co-Chair Senior Director of Clinical Affairs Ross Anderson, MD, Presidential Endowed Chair in Surgery Professor and Chair, Department of Surgery Sunil Sharma, MD, Co-Chair Senior Director of Clinical Research Jon and Karen Huntsman Presidential Professor in Cancer Research Professor, Department of Internal Medicine Wallace Akerley, MD, DSMC Senior Director of Community Oncology Research, HCI Co-Leader, Imaging, Diagnostics, and Therapeutics Program (IDT) Chair, Data and Safety Monitoring Committee Professor, Department of Internal Medicine David Gaffney, MD, PhD, CCIC Chair, Clinical Cancer Investigations Committee Professor, Department of Radiation Oncology Scott Lloyd, MBA, CPA, Finance and Administration Senior Director of Finance and Administration Donna Branson, BS, Minority Outreach Director, Patient and Public Education and Outreach Richard Lemons, MD, PhD, Pediatric representative (rotating) Professor, Department of Pediatrics Chief, Pediatric Hematology/Oncology Primary Children�s Medical Center Guido Tricot, MD, PhD, Faculty representative (rotating) Director, Utah Blood & Marrow Transplant and Myeloma Program Professor of Medicine Robert Andtbacka, MD, CM, FRCSC, MDG representative (rotating) Assistant Professor, Department of Surgery Mary Beckerle, PhD, Ad hoc Executive Director, Huntsman Cancer Institute Jennifer Katz, BS, CCRP, Ad hoc Clinical Research Administrative Director Director, Compliance and Monitoring Brad Bott, MBA, CCRP, Ad hoc Clinical Trials Office Manger Non-voting members Protocol Review Monitoring System The Clinical Cancer Investigations Committee (CCIC) was established to provide scientific review for all cancer trials as required by National Cancer Institute (NCI) Cancer Center Support Grant (CCSG) guidelines. All clinical trials at the University of Utah that involve cancer patients or subjects at risk for cancer (screening or prevention studies) must undergo an initial review by the CCIC. Two reviewers with no involvement in the trial under review, a biostatistician, a research pharmacist, a research nurse, a patient advocate, and an imaging specialist provide written reviews. CCIC Members: David Gaffney, MD, PhD, Chair Professor Radiation Oncology Leigh Neumayer, MD, Vice Chair Professor of Surgery Neeraj Agarwal, MD Assistant Professor Kenneth M Boucher, PhD Research Associate Professor (Biostats) Oncological Sciences Saundra Buys, MD Professor, (Oncology) Department of Internal Medicine Lisa Cannon-Albright, PhD Biomedical Informatics Jennifer Demko, RN, BSN, OCN Research Nurse, (Nursing) Tom Greene, PhD Professor (Clinical Epidemiology) Department of Internal Medicine Karen A Heichman, PhD Director/ARUP Elke A. Jarboe, MD Assistant Professor Melissa Johnson, PharmD Adjunct Professor, College of Pharmacy Michael A Pulsipher, MD Associate Professor of Internal Medicine (Hematology) Sadie Quinn (Patient Advocate) Stephanie Sanders, PharmD Clinical Pharmacist Sunil Sharma, MD, FACP Senior Director of Clinical Research Professor of Internal Medicine (Oncology) Ex-Officio Members: Mary C. Beckerle, PhD Cancer Center Director Ad Hoc Nursing: Kathi Mooney, RN, PhD Margaret Clayton, PhD APRN-BC Ad Hoc Genetics: Vickie L. Venne, MS Visit the CCIC website. Data and Safety Monitoring Committee* The Data and Safety Monitoring Committee (DSMC) was established by HCI in response to NCI and NIH requirements. Data and safety monitoring functions are separate and distinct from the study review and approval performed by the Institutional Review Board (IRB) and the scientific review conducted by the CCIC. DSMC members: Wallace Akerley, MD, Chair Professor of Medicine Senior Director of Community Oncology Research William Dunson, MD, Vice Chair Assistant Professor Medical Director, HCH Outpatient Clinics Medical Director, Internal Medicine Acute Care Clinic Zeinab Afify, MD Associate Professor Pediatric Hematology/Oncology Dennis Shrieve, MD, PhD Professor Department Chair, Radiation Oncology Maurizio Zangari, MD Professor Hematology/Blood & Marrow Transplant Kenneth Boucher, PhD Research Associate Professor Oncological Sciences Kylee Arbogast, BS, CCRP Compliance Office, Research Compliance Heather Bailey, BA* Administrative Assistant Gina Gregovich, BA, CCRP Project Administrator, Research Compliance Jennifer Katz, BS, CCRP Administrative Director, Clinical Research Shanon Matkin, BS, CCRP Compliance Office, Research Compliance * non-voting member Two subcommittees of the DSMC were established to monitor study and data integrity: Data Quality Subcommittee - The Data Quality Subcommittee (DQS) is responsible for performing full audits of all HCI-originated studies and any other active clinical trials not externally audited. Audits include review of eligibility, protocol compliance, toxicity grading, adverse event reporting, data quality, consent process, other regulatory compliance, and pharmacy compliance. Audits are routinely performed following accrual of the third patient to the study and then annually. More frequent audits can be mandated if serious concerns arise during planned audits. Audit results are reported to the DSMC, the IRB, and the PI. If closure is recommended or a project amendment results from the audit findings, the CCIC is notified. Endpoint Review Subcommittee - The Endpoint Review Subcommittee (ERS) is responsible for reviewing and certifying responses, survival, or other major study endpoints for all HCI-originated studies. Protocol endpoints are reviewed at times specified by early stopping rules and at completion of the study. Subcommittee review is required prior to publication. Results are reported to the DSMC, the CCIC, and the PI, and are incorporated into the research record.