Navigate Up
UPMC/University of Pittsburgh Schools of the Health Sciences
For Journalists
Managers
Telephone: 412-647-9975
Manager
Telephone: 412-647-9966
Other Inquiries



UPCI Contributes to National ‘Checklist’ for Personalized Testing in Cancer Clinical Trials


PITTSBURGH, Oct. 16, 2013 – A University of Pittsburgh Cancer Institute (UPCI) professor contributed to guidelines that will be used by the National Cancer Institute (NCI) to evaluate proposals for clinical trials that include biological assessments of individual cancer risk and treatment recommendations.


William L. Bigbee, Ph.D., previous leader of the Cancer Biomarkers Facility at UPCI and outgoing chair of the National Institutes of Health Cancer Biomarkers Study Section, is co-author of an article in the Oct. 1, 2013 issue of the journal Nature that includes a proposed, 30-point NCI “checklist” of criteria for the use of “omics-based” predictors in clinical trials.


Tests based on “omics” are those that use computational modeling to interpret molecular measurements of blood, tissue or other bodily samples in order to recommend a clinical course of action, such as cancer therapy or preventative surgery. Genomics, transcriptomics and proteomics are among the fields of study that are the basis of these tests.


“Omics-based tests are very powerful, emerging tools that are revolutionizing medicine, particularly in predicting and treating cancer,” said Dr. Bigbee, also professor of pathology in Pitt’s School of Medicine. “However, there are many variables and opportunities for error, including study design, patient selection, biological sample integrity, and data analysis and management. The NCI checklist is intended to provide clear expectations and guidelines for the development and implementation of omics-based tests and will hopefully eliminate unintentional errors.”


The Nature paper, written by lead author Lisa M. McShane, Ph.D., and senior author Barbara A. Conley, M.D., both of NCI, was published in conjunction with an “explanation and elaboration” paper in the journal BMC Medicine.


The checklist is the result of a 2011 Institute of Medicine review of the omics field and the recommendations of a 2011 NCI workshop bringing together scientists and stakeholders in this research. The review and workshop arose following widely publicized cases of premature advancement of omics-based tests used to guide treatment decisions.


The checklist is divided into these five sections:

  • specimen issues
  • assay issues
  • model development, specification and preliminary performance evaluation
  • clinical trial design
  • ethical, legal and regulatory issues

Based on his research expertise in cancer biomarkers, Dr. Bigbee’s primary contributions to the checklist involved the specimen and assay issues sections.


“There’s a whole series of issues involving the biological specimens selected for omics-based testing on which research conclusions and clinical recommendations will be made,” said Dr. Bigbee. “From which patients will biological specimens be obtained? Are the selected patients representative of all relevant patients with a given malignancy? How are these specimens collected, processed and stored to ensure reproducible results?”


For example, if a research project seeks to use omics-based testing to determine the best course of treatment for an individual cancer patient, it is important that the predictor be developed and tested in specimens from patients with similar clinical characteristics, including stage of disease.


“The field is rife with promising results in patients with late-stage cancer that may or may not be relevant to patients with early-stage cancer,” said Dr. Bigbee. “We don’t want to give the wrong toxic drugs to patients or give them too much or too little. The goal of personalized medicine is to give the right therapy to the right patient at the right time.”


Additional co-authors include Margaret M. Cavenagh, M.S., Tracy G. Lively, Ph.D., P. Mickey Williams, Ph.D., Mei-Yin C. Polley, Ph.D., Kelly Y. Kim, Ph.D., James V. Tricoli, Ph.D., Deborah J. Shuman, Richard M. Simon, D.Sc., and James H. Doroshow, M.D., all of NCI; David A. Eberhard, M.D., Ph.D., of the University of North Carolina; Jill P. Mesirov, Ph.D., of the Massachusetts Institute of Technology and Harvard University; and Jeremy M.G. Taylor, Ph.D., of the University of Michigan.

©  UPMC | Affiliated with the University of Pittsburgh Schools of the Health Sciences
Supplemental content provided by A.D.A.M. Health Solutions. All rights reserved.

For help in finding a doctor or health service that suits your needs, call the UPMC Referral Service at 412-647-UPMC (8762) or 1-800-533-UPMC (8762). Select option 1.

UPMC is an equal opportunity employer. UPMC policy prohibits discrimination or harassment on the basis of race, color, religion, ancestry, national origin, age, sex, genetics, sexual orientation, marital status, familial status, disability, veteran status, or any other legally protected group status. Further, UPMC will continue to support and promote equal employment opportunity, human dignity, and racial, ethnic, and cultural diversity. This policy applies to admissions, employment, and access to and treatment in UPMC programs and activities. This commitment is made by UPMC in accordance with federal, state, and/or local laws and regulations.

Medical information made available on UPMC.com is not intended to be used as a substitute for professional medical advice, diagnosis, or treatment. You should not rely entirely on this information for your health care needs. Ask your own doctor or health care provider any specific medical questions that you have. Further, UPMC.com is not a tool to be used in the case of an emergency. If an emergency arises, you should seek appropriate emergency medical services.

For UPMC Mercy Patients: As a Catholic hospital, UPMC Mercy abides by the Ethical and Religious Directives for Catholic Health Care Services, as determined by the United States Conference of Catholic Bishops. As such, UPMC Mercy neither endorses nor provides medical practices and/or procedures that contradict the moral teachings of the Roman Catholic Church.

© UPMC
Pittsburgh, PA, USA UPMC.com