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Blog from June, 2013
SYNOPSIS:Markers are becoming more important in NCI-supported clinical trials. These trials are becoming increasingly oriented toward precision medicine. Unfortunately, Program Staff do not have access to a database that tracks such markers to make sure their use can be managed. The Center for Coordinating Clinical Trials (CCCT) was mandated to create the Clinical Trials Reporting Project (CTRP) to coordinate tracking all elements of the clinical trials. CTRP now contains nearly 7,000 trials with roughly half of them including markers on all patients; 12% of said trials have integral markers that are essential for performance of the trial, e.g., mutations for eligibility for targeted therapies. The presentation will cover the CTRP Marker database and its potential as a resource for staff and potentially the public.
BIO:
Kim Jessup, M.D. is a surgical oncologist who joined the Cancer Diagnosis Program at NCI as Chief of the Diagnostics Evaluation Branch in 2006. This branch facilitates the transition of discovery-based markers into in-vitro diagnostics that are used in clinical trials. As part of this effort, Dr. Jessup helped with the creation of the Markers Database in the Clinical Trials Reporting Project as well as the creation of electronic case-report forms (eCRFs) for pharmacodynamic assays for the Experimental Therapeutics-Clinical Trials Network. He also collaborates with the FDA to standardize assays for clinical trials and assists investigators in navigating the requirements for Investigational Device Exemption. In 25 years of practice, he has focused on the multidisciplinary treatment of GI and breast cancer, melanoma, and soft tissue/skeletal sarcomas in several different academic settings. In addition, he led a research effort studying the mechanisms that underpin hepatic metastasis by human colorectal carcinoma and identified two distinct roles for the marker carcinoembryonic antigen in modulating inflammatory responses and promoting metastasis. Currently, Dr. Jessup is a Principal Investigator in the Laboratory of Experimental Carcinogenesis in the NCI Center for Cancer Research. His research targets a novel embryonic retrogene that drives cancer stem cells in metastatic human colorectal carcinoma.
SUMMARY:
Topic: The Good, The Bad and The Ugly for Clinical Markers: Possibilities For the Future
Speaker: Dr. Kim Jessup
Date: Wednesday, June 26, 2013
Time: 11 AM – 12 PM
Dr. Jessup will give his presentation in person at 2nd Floor East, Room 032-034 at the NCI Shady Grove Building on Medical Center Drive. The presentation will also be available via WebEx.
Presentation: A screen cast of the presentation will be available for viewing after the event here on our Speaker Series Videos page on the NCI’s CBIIT Speaker Series YouTube Playlist 
.
About the NCI CBIIT Speaker Series:
The National Cancer Institute (NCI) Center for Biomedical Informatics and Information Technology (CBIIT) Speaker Series is a bi-weekly knowledge-sharing forum featuring both internal and external speakers on topics of interest to the biomedical informatics and research communities. For additional information, including past speaker series presentations, visit the CBIIT Speaker Series page.
Questions? Please email us at NCICBIITcomms@mail.nih.gov.
Individuals with disabilities who need reasonable accommodation to participate in this program should contact the Office of Space and Facilities Management (OSFM) at 240-276-5900 or the Federal TTY Relay number 1-800-877-8339.
SYNOPSIS:The standard lexicon for reporting adverse events in National Cancer Institute sponsored clinical trials is the Common Terminology Criteria for Adverse Events (CTCAE). Currently, adverse events are reported by clinicians, yet evidence suggests that compared to patient-report, clinicians may underestimate symptom severity and onset.
The NCI Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a new patient-reported outcome measurement system that elicits the frequency, severity and interference of 78 treatment toxicities that can be reported from the patient perspective. This presentation offers an overview of the PRO-CTCAE measurement system and the interdisciplinary consortium in which it is being developed and tested, and suggests the trial contexts in which patient reporting of toxicity is likely to provide the greatest value and informational yield, as well as the challenges faced in developing this approach to adverse event reporting. Session details...
After outlining the factors that drive an expanding imperative to incorporate the patient perspective into the assessment of treatment tolerability and safety, the traditional approach to adverse event reporting is contrasted with a paradigm that seeks to incorporate the patient perspective. The key elements of the PRO-CTCAE measurement system are exhibited, and the research challenges, gaps in knowledge, and the issues that will need to be resolved to fully implement this new approach are examined. The presentation concludes by highlighting (i) NCI efforts to make PRO-CTCAE more widely available to investigators in the extramural community, including academic and industry investigators both in the U.S. and internationally; (ii) ongoing PRO-CTCAE consortium studies to evaluate and refine both the PRO-CTCAE items and the electronic system for patient-reported AE ascertainment and to scale up for integration into the clinical trial workflow and into existing platforms for electronic data capture and electronic health records; and (iii) envision some of the future directions for PRO-CTCAE, as both a drug development tool and as a potential platform upon which to build improvements in symptom management and care quality for patients participating in cancer clinical trials.
BIOs:
Dr. Sandra A. Mitchell is a research scientist in the Outcomes Research Branch of the Applied Research Program, Division of Cancer Control and Population Sciences, at NCI. Her work focuses on the development and testing of measures of symptom burden, physical function, and sleep and fatigue in patients with cancer, and the application of these outcomes to evaluate therapeutic response and treatment toxicity in clinical trials. Her methodologic interests include latent variable mixture modeling to characterize underlying heterogeneity, as well as analysis and interpretation issues surrounding patient-reported outcomes, including health-related quality of life.
A board certified acute-care nurse practitioner, Dr. Mitchell maintains a clinical practice as an Oncology Nurse Practitioner with the Experimental Transplantation and Immunology Branch, NCI Intramural Program, focusing on long-term survivors of allogeneic hematopoietic stem cell transplantation with chronic graft-versus-host disease. She also serves as the program director for the development and testing of PRO-CTCAE, a new measurement system to integrate patient reporting of symptomatic adverse events into cancer clinical trials.
Dr. Mitchell received her undergraduate and master’s degrees from the University of Toronto and the University of Rochester, and received a Ph.D. from the University of Utah with a focus in quantitative methods. The author of more than 50 peer-reviewed publications in the areas of symptom management, functional status, cancer survivorship, and the application of quality-of-life outcomes in evaluating therapeutic response to treatment, Dr. Mitchell’s work has been recognized with numerous awards, including two NIH Clinical Center Director’s Awards and the Oncology Nursing Society’s Award for Excellence in Nursing-Sensitive Patient Outcomes.
SUMMARY:
Topic: Capturing Symptom Burden and Treatment Tolerability in Cancer Clinical Trials, Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Speaker: Dr. Sandra A. Mitchell
Date: Wednesday, June 12, 2013
Time: 11 AM – 12 PM
Presentation: A screen cast of the presentation will be available for viewing after the event here on our Speaker Series Videos page and on the NCI’s CBIIT Speaker Series YouTube Playlist .
About the NCI CBIIT Speaker Series:
The National Cancer Institute (NCI) Center for Biomedical Informatics and Information Technology (CBIIT) Speaker Series is a bi-weekly knowledge-sharing forum featuring both internal and external speakers on topics of interest to the biomedical informatics and research communities. For additional information, including past speaker series presentations, visit the CBIIT Speaker Series page.
Questions? Please email us at NCICBIITcomms@mail.nih.gov.
Individuals with disabilities who need reasonable accommodation to participate in this program should contact the Office of Space and Facilities Management (OSFM) at 240-276-5900 or the Federal TTY Relay number 1-800-877-8339.
