National Cancer Institute

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National Cancer Institute

Office of Advocacy Relations

Office of Advocacy Relations

National Cancer Institute News - Events and More...

Nominations Open for NCI Director’s Consumer Liaison Group

The National Cancer Institute (NCI) is in the process of identifying individuals to serve on the Director’s Consumer Liaison Group (DCLG). The NCI Director’s Consumer Liaison Group is a Federal Advisory Committee of 16 people who advise the NCI Director from the viewpoint of the consumer advocate. The Institute will be filling three positions on the board with dates of service beginning July 2009 and running through June of 2013. All nomination materials must be received by NCI no later than 6:00 p.m. (ET) on Friday, May 22, 2009.

Ideal candidates will have first-hand knowledge of the cancer experience, be affiliated with a cancer-related constituency, and possess relevant non-scientific skills and perspectives that will allow them to help improve research outcomes by identifying new approaches, promoting innovation, recognizing unforeseen risks or barriers, and identifying unintended consequences that could result from NCI decisions. Nominees who offer the strongest collection of skills and perspectives that complement the expertise of current members will be selected for membership.

For further information about the DCLG and complete details about the nomination process...

Previous nominees should be aware that in order to be considered for current vacancies, their updated materials must be re-submitted for consideration. Please submit any questions by email.

Teleconference NCI Co-Sponsors 7th Annual Survivorship Series with CancerCare, LAF & Others

Living With, Through and Beyond Cancer

This free series, made possible by support from the National Cancer Institute and Lance Armstrong Foundation, offers cancer survivors, their families, friends and health care professionals practical information to help them cope with concerns and issues that arise after treatment ends.

Part II entitled, The Importance of Nutrition and Physical Activity, will be held on Tuesday, May 19 from 1:30 – 2:30 pm, Eastern Time.

The featured speakers for this program include:

  • Anna Schwartz, FNP, PhD, FAAN, Cancer Survivor, Executive Medical Director, Rehabilitation Systems and Affiliate Professor, University of Washington;
  • Bernardine M. Pinto, PhD, Professor (Research), The Miriam Hospital and the Warren Alpert Medical School of Brown University, Centers for Behavioral and Preventive Medicine; and
  • Wendy Demark-Wahnefried, PhD, RD, Professor, Department of Behavioral Science, The University of Texas MD Anderson Cancer Center

Part III entitled, Family, Friends and Loved Ones - Managing the Fatigue of Caregiving, will be held on Tuesday, June 23 from 1:30 – 2:30 pm, Eastern Time.

The featured speakers for this program include:

  • Joe Sommer, Caregiver, Executive Director, AT&T Intellectual Property
  • Laurel L. Northouse, RN, PhD, FAAN, Mary Lou Willard French Professor of Nursing, University of Michigan School of Nursing, Co-Director, Socio-Behavior Program, University of Michigan Comprehensive Cancer Center
  • Shelby L. Langer, PhD, Research Assistant Professor, University of Washington School of Social Work, Affiliate Investigator, Biobehavioral Sciences, Fred Hutchinson Cancer Research Center

These workshops are free – no phone charges apply. However, pre-registration is required. To register simply go to the CancerCare website and click on Register for a Telephone Education Workshop.

Understanding NCI Toll-Free Teleconference Series Continues

The Understanding NCI Toll-Free Teleconference Series is one way NCI’s Office of Advocacy Relations facilitates dialogue between NCI and the community. The teleconference series informs the advocacy community about NCI’s important research activities and programs – and how advocates are involved. Callers will have the opportunity to ask questions.

Teleconference Cancer as a Model for Research, June 25, 2009 from 1:00 – 2:00 p.m. (ET)

Topic: This call will explore how cancer research is much broader than cancer. Cancer research advances can lead to advances in other areas of research (i.e. HIV/AIDS, cardiovascular disease, diabetes).

Speaker:

  • Dr. Lee Helman, Scientific Director for Clinical Research, NCI Center for Cancer Research

USA Toll-Free: 1-800-857-6584         Passcode: CCR
Toll-Free Playback: 1-866-465-0338 through July 25, 2009
For more information…

Teleconference Teleconference Postponed on Collaborations: Essential to Cancer Research

Notices will be sent when a new date is selected for this teleconference focusing on how NCI collaborates with academia, industry, and other partners to meet the institute’s research goals. It features Dr. James H. Doroshow, Director, NCI Division of Cancer Treatment and Diagnosis. For more information…

Teleconference NCI Community Cancer Centers Program (NCCCP): Translating Scientific Advances into the Community Teleconference Replay Available

The Office of Advocacy Relations (OAR) invites you to listen to a replay of the Understanding NCI: Toll-Free Teleconference Series on Translating Scientific Advances into the Community. The NCI Community Cancer Centers Program (NCCCP) is a three-year pilot program to test the concept of a national network of community cancer centers to expand cancer research and deliver the latest, most advanced, cancer care to a greater number of Americans in their communities.

The featured speakers are Dr. Maureen Johnson, NCCCP Project Officer; Dr. Beverly Laird, Co-Chair of the NCI Director’s Consumer Liaison Group; Dr. Jay Harness, Principal Investigator of the NCCCP site at St. Joseph Hospital in Orange, California; Ms. Nancy Harris, Administrator at the Center for Cancer Prevention and Treatment at St. Joseph Hospital in Orange, California; Dr. Mark Krasna, Principal Investigator at the NCCCP site at Catholic Health Initiatives and Medical Director at St. Joseph Cancer Institute in Towson, Maryland; and Ms. Donna Costa, Outreach Coordinator at St. Joseph Cancer Institute in Towson, Maryland. A question and answer session follows the presentations.

The replay is available until May 21, 2009 by dialing 1-866-457-5714.
For more information about the NCCCP...

Visit OAR’s website for information on the teleconference series.

Cancer News

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Formaldehyde Exposure among Industrial Workers Is Associated with Increased Risk of Cancers of the Blood and Lymphatic System (5/12/09)

Results from an ongoing study of workers employed at plants that used or produced formaldehyde continue to show a possible link between formaldehyde exposure and death from cancers of the blood and lymphatic system, particularly myeloid leukemia. The report, by researchers at the National Cancer Institute (NCI), part of the National Institutes of Health, provides an additional 10 years of follow-up data to build on previous findings from this study. Read more…

Cancer and Women (5/11/09)

Every year, cancer claims the lives of more than a quarter of a million women in America. A woman can reduce her cancer risk by adopting a healthy lifestyle and getting the right cancer screening tests for her stage of life. Read more…

Genes Help Breast Cancer Cells Invade the Brain (5/11/09)

Scientists have identified 3 genes that help breast cancer cells gain access and take root in the brain. The finding points to potential new strategies for blocking the often-deadly spread of cancer to the brain and other parts of the body. Read more…

FDA Approves Drug for Treatment of Aggressive Brain Cancer (5/8/09)

The U.S. Food and Drug Administration recently approved Avastin (bevacizumab) to treat patients with glioblastoma multiforme (GBM) when this form of brain cancer continues to progress following standard therapy. GBM is a rapidly progressing cancer that invades brain tissue and can impact physical activities and mental abilities. Read more…

Biomarker Can Distinguish Between Cell Death and DNA Damage (5/8/09)

NCI researchers have identified a molecular ring pattern that could be used as a biomarker to identify and distinguish between cells that are programmed for death from cells that have a particular type of DNA damage. Such biomarkers could provide new tools for basic cellular biology research, but also help to mark cell death in clinical samples and monitor the efficacy of anticancer regimens. Read more…

Targeted Immune Cells Shrink Tumors in Mice (Updated 5/7/09)

Researchers have generated altered immune cells that are able to shrink, and in some cases eradicate, large tumors in mice. The immune cells target mesothelin, a protein that is highly expressed, or translated in large amounts from the mesothelin gene, on the surface of several types of cancer cells. Read more…

FDA Granted Accelerated Approval to Bevacizumab Injection (5/5/09)

The U.S. Food and Drug Administration granted accelerated approval to bevacizumab injection (Avastin, Genentech, Inc.) as a single agent for patients with glioblastoma, with progressive disease following prior therapy. Read more…

New Early Detection Studies of Lung Cancer in Non-Smokers Launched (5/4/09)

Government and private sector cancer scientists launched a research partnership to find biomarkers for lung cancer that develops in people who have never smoked. The research studies are designed to create a better understanding of the biology of lung cancer and to develop a test to detect early-stage lung cancer in lifetime nonsmokers. Read more…

Catch Oral Cancer Early (5/09)

Oral cancer can affect the mouth and the back of the throat. Chances of survival drop once the cancer spreads to other parts of the body. That’s why it’s so important to find oral cancer early, when it can be treated more successfully. Read more…

Public Health Cancer News

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NIH News in Health – No More Butts, Snuff Out That Cigarette for Good (5/09)

If you’re a smoker, chances are you’ve already tried to quit. So you know from experience that it’s not easy. Many ex-smokers say quitting was one of the hardest things they’ve ever done. But many do succeed in the end. And the health benefits they gain make quitting worth the effort.  Read more…

Many High School Students Who Try to Quit Smoking Are Unsuccessful (4/30/09)

Despite their relatively short smoking histories, many adolescents who smoke and try to quit are unsuccessful. Interventions that prevent initiation and increase quitting should be fully implemented to lower the prevalence of smoking among youth. Read more…

Policy News

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HHS Secretary Kathleen Sebelius Issues Statement on New Medicare Trustees’ Report (5/12/09)

Health and Human Services Secretary Kathleen Sebelius issued the following statement regarding the new Medicare Trustees’ report. A joint statement regarding the report from the Medicare Trustees is also available at the Social Security Website. Read more…

HHS Budget Puts Reform First (5/7/09)

Citing the rapidly escalating cost of health care in this country and the enormous pressures that health care costs are putting on our economic future, Health and Human Services Secretary Kathleen Sebelius highlighted key reforms in President Obama’s 2010 HHS budget. Read more…

Senate Confirms Two Key Leaders (5/7/09)

HHS Secretary Kathleen Sebelius welcomed Deputy Secretary Bill Corr and Indian Health Service Director Dr. Yvette Roubideaux to the Department of Health and Human Services. Read more…

Secretary Sebelius Highlights Two New Reports on Health Care Quality, Says Improving Quality is Key Component of Health Reform (5/6/09)

At a speech before the AFSCME Nurses Conference Secretary Kathleen Sebelius discussed two new HHS reports on the quality of health care in America and challenged hospitals to work to reduce health care associated infections. Published by the Agency for Healthcare Research and Quality, the annual 2008 National Healthcare Quality Report and 2008 National Healthcare Disparities Report indicate that patient safety measures have worsened and that a substantial number of Americans do not receive recommended care. Read more...

HHS Releases New Report – Hard Times in the Heartland: Health Care in Rural America (5/4/09)

Health and Human Services Secretary Kathleen Sebelius released a new report, Hard Times in the Heartland: Health Care in Rural America, outlining the health care challenges facing rural communities. The report was developed by HHS staff from across the department and comes on the same day Director of the White House Office of Health Reform Nancy-Ann DeParle, HRSA Administrator Mary Wakefield, and Representative Mike Ross will hold a meeting with Americans from rural communities as part of the ongoing series of White House Health Care Stakeholder Discussions. For more information, see the Press Release. View Report…

NIH Reiterates Stance on Terrorism and Violence Against Researchers (4/17/09)

NIH Acting Director Raynard Kington, M.D., Ph.D. has issued a statement condemning terrorist acts against researchers and institutions who use animals in their work. Dr. Kington emphasized the important role that these researchers play in the health of our nation and that federal funding supporting their work is based on national health needs. Dr. Kington further reiterated the high standards of accountability for animal welfare to which their research is held in order to receive federal funds. Read more…

Fact Sheets, Websites, & Publications

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New Website – Smokefree Women (5/11/09)

Women.Smokefree.gov is intended to help you or someone you care about quit smoking and is designed to try to provide information about topics that are often important to women. View Website…

New Website – Cancer Imaging Program (5/11/09)

Imaging, by itself, is not a treatment but can help in making better decisions about treatments. The same imaging technique can help doctors find cancer, tell how far a cancer has spread, guide delivery of specific treatments, or find out if a treatment is working. View Website…

Flyer: Clean Hands Save Lives! (5/6/09)

The CDC continues to investigate human cases of H1N1 flu in the United States and is working closely with Canada, Mexico and with the World Health Organization (WHO). As a part of its response to the outbreak, CDC is issuing new H1N1 flu guidance. In addition, a one-stop access Web site has been launched to bring together information from various federal agencies. For more information on H1N1 situation, please visit PandemicFlu.gov. View Flyer…

New Community Guide Website Launched (5/4/09)

CDC’s Guide to Community Preventive Services has launched a website which is a free resource to help you choose programs and policies to improve health and prevent disease in your community. View Website…

Fact Sheet – Calcium and Cancer Prevention: Strengths and Limits of the Evidence (5/4/09)

Calcium is an essential dietary mineral commonly found in milk, yogurt, cheese, and dark green vegetables. The results of some studies suggest that a high calcium intake may decrease the risk of one or more types of cancer, whereas other studies suggest that a high calcium intake may actually increase the risk of prostate cancer. View Fact Sheet…

Fact Sheet – Asbestos Exposure and Cancer Risk (5/1/09)

Asbestos is the name given to a group of minerals that occur naturally in the environment as bundles of fibers. Exposure to asbestos may increase the risk of asbestosis, other nonmalignant lung and pleural disorders, lung cancer, mesothelioma, and other cancers. View Fact Sheet…

IOM Workshop Summary – Ensuring Quality Cancer Care Through the Oncology Workforce: Sustaining Care in the 21st Century (4/29/09)

The American Society of Clinical Oncology (ASCO) predicts that by 2020, there will be an 81 percent increase in people living with or surviving cancer but only a 14 percent increase in the number of practicing oncologists. As a result, there may be too few oncologists to meet the population’s need for cancer care. To help address the challenges in overcoming this potential crisis of cancer care, the National Cancer Policy Forum of the Institute of Medicine (IOM) convened the workshop. Read more…

Events

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Editor’s Note: All of these events, and more, are updated daily on the Office of Advocacy Relations website where you can view upcoming meetings, conferences, opportunities for public comment, programs open for applications, and teleconferences.

Meeting – Food and Drug Administration Science Board (5/18/09) Rockville, MD

The Science Board will hear about and discuss updates from the following subcommittees: (1) The review of each Center's projects within scientific priority areas, (2) the review of research at the Center for Veterinary Medicine, and (3) the review of FDA's scientific information technology infrastructure modernization initiatives. The Science Board will also hear updates on rapid detection of Salmonella in foods and the handling of biospecimens used for genomic and proteomic analyses. More information…

Meeting – Clinical Trials Endpoints for Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation (5/19/09) Rockville, MD

The Food and Drug Administration (FDA) and National Institutes of Health (NIH) in co-sponsorship with the Center for International Blood and Marrow Transplantation Research (CIBMTR) and the American Society for Blood and Marrow Transplantation (ASBMT) are hosting a 1-day workshop for academics, government researchers, clinical trial experts, government regulators, and industry representatives. The purpose of the public workshop is to review the data that will serve as the foundation for protocol design and clinical trial evidence-based endpoints intended to support the approval of new drugs or biologics to prevent or treat acute GVHD. The public workshop also will inform FDA and assist investigators in facilitating clinical development programs for products to prevent or treat acute GVHD indications. More information…

Meeting – Gastrointestinal Drugs Advisory Committee Meeting (5/20/09) Silver Spring, MD

The committee will discuss the safety and efficacy of new drug application (NDA) 22-336 REZONIC, (casopitant mesylate) tablets, GlaxoSmithKline, in combination with other antiemetic agents for the proposed indications of prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy (HEC), prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC), and prevention of postoperative nausea and vomiting. More information…

Conference – Personal Electronic Health Records: From Biomedical Research to People’s Health (5/20/09-5/21/09) Bethesda, MD

This will be an important and timely conference dedicated to a state-of-the-art review of the implementation of Personal Electronic Health Records. Alternative systems and their settings will be reviewed by the experts managing their development and implementation. Presentations addressing systemic, clinical, patient, research, legal/ethical and national policy issues will be featured throughout the two-day meeting. More information…

Public Comment – Draft Guidelines for Human Stem Cell Research – Comments must be submitted by May 22, 2009

The National Institutes of Health (NIH) is requesting public comment on draft guidelines entitled "National Institutes of Health Guidelines for Human Stem Cell Research." The purpose of these draft Guidelines is to implement Executive Order 13505, issued on March 9, 2009, as it pertains to extramural NIH-funded research, to establish policy and procedures under which NIH will fund research in this area, and to help ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law.

These draft Guidelines would allow funding for research using human embryonic stem cells that were derived from embryos created by in vitro fertilization (IVF) for reproductive purposes and were no longer needed for that purpose. Funding will continue to be allowed for human stem cell research using adult stem cells and induced pluripotent stem cells. Specifically, these Guidelines describe the conditions and informed consent procedures that would have been required during the derivation of human embryonic stem cells for research using these cells to be funded by the NIH. NIH funding for research using human embryonic stem cells derived from other sources, including somatic cell nuclear transfer, parthenogenesis, and/or IVF embryos created for research purposes, is not allowed under these Guidelines.

Submit comments online by 11:00 p.m. ET on May 22, 2009, or by mail to NIH Stem Cell Guidelines, MSC 7997, 9000 Rockville Pike, Bethesda, Maryland, 20892-7997. More information…

Meeting – Moving Into the Future--New Dimensions and Strategies for Women's Health Research (5/27/09 – 5/29/09) San Francisco, CA

This public hearing and scientific workshop is the second in a series that will be convened throughout the Nation to assist the Office of Research and Women’s Health and the NIH to move into the next decade of women's health research. The meeting format is designed to promote an interactive discussion involving leading scientists, advocacy groups, public policy experts, health care providers, and the general public. The ideas and recommendations emerging from this conference and other regional conferences will help inform future women’s health research priorities at the NIH. More information…

Meeting – DC Area Healthy People 2020 Stakeholders Meeting (5/28/09) Bethesda, MD

The purpose of the meeting is to obtain public perspectives on the framework that will be used to organize Healthy People 2020 objectives. Public comment on specific objectives will be sought. More information…

Meeting – Anesthesiology and Respiratory Therapy Devices Panel (5/28/09) Gaithersburg, MD

The committee will discuss, make recommendations, and vote on a premarket approval application for the SEDASYS\TM\Computer-Assisted Personalized Sedation System sponsored by Ethicon Endo-Surgery, Inc. The device is indicated for the intravenous administration of 1% (10 milligrams/milliliters) propofol injectable emulsion for the initiation and maintenance of minimal to moderate sedation, as identified by the American Society of Anesthesiologists Continuum of Depth of Sedation, in adult patients (American Society of Anesthesiology physical status I, II, or III) undergoing colonoscopy and esophagogastroduodenoscopy procedures. More information…

Meeting – Oncologic Drugs Advisory Committee (5/29/09) Orlando, FL

The committee will discuss the biologics license application (BLA) 125326, proposed trade name ARZERRA (ofatumumab), GlaxoSmithKline, for the proposed indication of treatment of patients with chronic lymphocytic leukemia who have received prior therapy. More information…

Public Comment – Revisions to the NIH Guidelines for Research Involving Recombinant DNA Molecules – Comments must be submitted by June 1, 2009

For the purposes of clarification and in acknowledgement of the rapidly developing field of synthetic biology, the NIH is proposing a number of amendments to the current NIH Guidelines. The proposed revisions to the NIH Guidelines include:

  • Broadening the scope of the NIH Guidelines, which currently cover laboratory and clinical research involving DNA molecules created via recombinant techniques (i.e., joining of DNA molecules). NIH proposes to encompass nucleic acids that are synthesized chemically or by other means without the use of recombinant technology.
  • Revising the criteria for determining when introduction of a drug resistance trait into a microorganism must be reviewed and approved by the NIH Director. NIH proposes to remove the current language regarding a microorganism's ability to acquire the trait naturally, since this criterion may not be determinative of the safety and public health implications of the research. The proposed amendment also contains additional language requiring consideration of the utility of the drug in certain subpopulations.
  • Changing the level of review for recombinant or synthetic experiments involving more than half but less than two-thirds of the genome of certain viruses in tissue culture, as described in Section III-E-1 of the NIH Guidelines.

Submit written or electronic information and comments by email by June 1, 2009. More information…

Meeting – National Vaccine Advisory Committee (6/2/09) Washington, D.C.

Topics to be discussed at the meeting include vaccine safety recommendations, the National Vaccine Plan, adult immunization recommendations, NVAC evaluation, vaccine stockpile, vaccine financing, 2009 H1N1 influenza outbreak, and other related issues. More information…

Public Comment – Request for Information and Comments on IRB Accountability – Comments must be submitted by June 3, 2009

The Office for Human Research Protections (OHRP), has issued a Federal Register notice requesting information and comments from the public about whether the office should pursue a notice of proposed rulemaking to enable OHRP to hold IRBs and the institutions or organizations operating the IRBs directly accountable for meeting certain regulatory requirements of 45 CFR part 46. OHRP is contemplating this regulatory change to encourage institutions to rely on IRBs that are operated by another institution or organization, when appropriate.

Submit written or electronic information and comments by June 3, 2009 by email. More information…

Meeting – Advisory Committee to the Director, NIH (6/4/09) Bethesda, MD

Among the topics proposed for discussion are: (1) NIH Director's Report; (2) NIH Director's Council of Public Representatives Liaison Report; and (3) other business of the Committee. More information…

Meeting – Implementation of Post-Approval Studies for Medical Devices Public Workshop (6/4/09-6/5/09) Silver Spring, MD

The purpose of the workshop is to facilitate discussion among FDA and other interested parties on issues related to the implementation of Post-Approval Studies for medical devices. Issues under discussion will include: regulatory requirements for implementing a Post-Approval Study for medical devices; challenges and successful strategies for the recruitment of participants for Post-Approval Studies; challenges and successful strategies for the retention and compliance with follow-up requirements of participants for Post-Approval Studies; using existing infrastructure (e.g., national registries) to facilitate Post-Approval Studies; using innovative strategies to facilitate Post-Approval Studies; clinical research organizations, industry, academia, and other clinical trial consultant's perspectives on all of the previous issues related to implementing Post-Approval Studies for medical devices. More information…

Meeting – National Advisory Council for Complementary and Alternative Medicine Meeting (6/5/09) Bethesda, MD

The agenda includes opening remarks by the Director of the National Center for Complementary and Alternative Medicine, presentation of a new research initiative, and other business of the Council. More information…

Public Comment – Comments Needed: Positron Emission Tomography (FDG PET) for Cervical Cancer - Comments must be submitted by June 7, 2009

Medicare already nationally covers FDG PET when it is used by the beneficiary's physician to guide the subsequent management of cervical cancer in women who have undergone anticancer treatment. FDG PET is also already nationally covered for some uses in women diagnosed with cervical cancer who have not yet received anticancer treatment. Specifically, FDG PET imaging is covered as an adjunct test for the detection of pre-treatment metastasis (i.e., staging) in newly diagnosed cervical cancers following conventional imaging that is negative for extra-pelvic metastasis. Medicare coverage of all other uses of FDG PET related to cervical cancer is restricted to beneficiaries who are enrolled in a prospective clinical study under Coverage with Evidence Development (CED).

The requestors have asked CMS to reconsider the National Coverage Decision (NCD) and nationally cover FDG PET more broadly (without the CED restriction) for the staging of cervical cancer, i.e. in those women who have been diagnosed with cervical cancer but who do not otherwise meet the coverage criteria. The requestors also ask that the use of FDG PET be nationally noncovered to make the diagnosis of cervical cancer, as FDG PET imaging is not helpful to make the initial diagnosis.

Submit comments online by June 7, 2009.

Meeting – Medicare Evidence Development and Coverage Advisory Committee (6/17/09) Baltimore, MD

This meeting will focus on the use of Bayesian statistics to interpret evidence in making coverage decisions. The meeting will introduce Bayesian concepts, contrast Bayesian approaches with frequentist approaches, and provide some examples of using Bayesian techniques for meta-analyses. Bayesian analysis is a statistical technique in which prior evidence is used to update or to newly infer the probability that a hypothesis may be true. More information…

Meeting – Board of Scientific Advisors (6/22/09 – 6/23/09) Bethesda, MD

The agenda includes: a report from the NCI Director regarding ongoing and new business; reports of program review group; budget presentations; reports of special initiatives; RFA and RFP concept reviews; and scientific presentations. More information…

Meeting – Public Consultation Meeting on Proposed Revisions to the NIH Guidelines for Research Involving Recombinant DNA Molecule (6/23/09) Arlington, VA

Discussions will focus on the proposed revisions to the NIH Guidelines which include: (1) Broadening the scope of the NIH Guidelines, which currently cover laboratory and clinical research involving DNA molecules created via recombinant techniques (i.e., joining of DNA molecules), to apply to nucleic acids that are synthesized chemically or by other means without the use of recombinant technology; (2) Revising the criteria for determining when the introduction of a drug resistance trait into a microorganism must be reviewed by the Recombinant DNA Advisory Committee and approved by the NIH Director; and (3) Changing the level of review required for recombinant or synthetic experiments involving more than one-half but less than two-thirds of the genome of certain viruses in tissue culture as described in Section III-E-1 of the NIH Guidelines. More information…

Meeting – Soy Protein and Isoflavones Research: Challenges in Designing and Evaluating Intervention Studies Workshop (7/28/09 – 7/29/09) Bethesda, MD

The purpose of this workshop is to provide guidance for the next generation of soy protein and isoflavone human research. Specifically, the workshop objectives are to identify (1) methodological issues relative to exposures and interventions that may confound study results and interpretation and (2) scientifically sound and useful options and solutions for dealing with these issues in the design, conduct, reporting of results, and interpretation of ongoing and future studies. NIH is seeking input from scientists from multiple disciplines. This highly participatory workshop will address issues related to population exposure to soy and other phytoestrogens, factors influencing variability of response to soy interventions and negative consequences of exposure, methods and tools to assess exposure, product composition, and analytic methods to assess soy product constituents and metabolites. More information…

Public Comment – Guidance on Determining Conflict of Interest for Participation in FDA Advisory Committees

The purpose of this guidance is to simplify and streamline the process by which FDA considers meeting participation, increase the transparency, clarity, and consistency of the process, and enhance public trust in this important function. The guidance incorporates a progressively more stringent cap on the numbers of waivers issued per fiscal year in accordance with FDAAA. If an individual or his spouse or minor child has disqualifying financial interests whose combined value exceeds $50,000, she generally would not participate in the meeting, regardless of the need for her expertise. FDA will not issue a waiver in certain circumstances where the agency has determined that the conflict of interest is significant.

Submit electronic comments using Docket number FDA-2007-D-0424 at any time. More information…

Free Educational Webcasts

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Demystifying Medicine – Multiple Myeloma: Diagnosis and Treatment in the Genomic Era

Tuesday, May 05, 2009
Geraldine Schechter, MD and Luis Staudt, MD
Total Running Time: 2:00:00

Targeting DNA Repair Pathways in Cancer Therapy

Tuesday, May 12, 2009
Alan D’Andrea, MD
Total Running Time: 1:00:00

Featured Clinical Trials

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Non-Small Cell Lung Cancer (NSCLC) Clinical Trial Continues at NCI’s Center for Cancer Research, NIH

Why is this non-small cell lung cancer (NSCLC) trial important?

Non-small cell lung cancer (NSCLC) is the leading cause of cancer death. Despite improvements in diagnosis, surgical techniques, radiation therapy and chemotherapy, most patients diagnosed with NSCLC will succumb to their disease. This clinical trial is studying a novel approach to anticancer vaccination. The vaccine used in this clinical trial attempts to elicit strong immune responses against patients' lung cancers by vaccinating patients with genetically modified human lung cancer cells expressing the enzyme alpha (1,3) galactosyltransferase (Alpha-GT). Alpha-GT is expressed in the tissues of lower mammals and generates antigens that induce powerful immune responses that cause the rapid rejection of organs and tissues transplanted from these animals into humans. Preclinical studies demonstrated that vaccination of mice with alpha-GT expressing tumor cells induced immune rejection of established tumors that were alpha-GT negative. This study will examine whether this vaccine can slow or stop the growth of advanced lung cancers in patients. For more information about this trial, please visit: http://bethesdatrials.cancer.gov/ola/morris/04c0049/default.aspx

For information about other cancer clinical trials conducted at the Center for Cancer Research, please visit: http://bethesdatrials.cancer.gov

There is no charge for medical care received at the National Institutes of Health (NIH) Clinical Center. Patients will be responsible for travel costs for their initial screening visits. In most cases, once patients are enrolled in a trial, the National Cancer Institute (NCI) will pay the transportation costs for all subsequent trial-related visits for patients who do not live in the local area. In addition, these patients will receive a small per diem for food and lodging expenses if they are being treated as outpatients.

It will be important to maintain your current insurance plan to cover all medical care that is provided away from the NIH Clinical Center.


A Word on the NCI Nealon Digest

The NCI Nealon Digest is a compilation of news from Federal cancer-related Web sites, including the National Cancer Institute. The contents are in the public domain. Readers are encouraged to duplicate this information in part or in its entirety in their newsletters, Web sites, etc.

The NCI Nealon Digest is named in honor of Ms. Eleanor O’Donoghue Nealon, an advocate’s advocate who built bridges among the cancer advocacy community, the scientific community, and the federal government. Although Ms. Nealon, the first director of the National Cancer Institute’s (NCI) Office of Liaison Activities (now the Office of Advocacy Relations), passed away in 1999 from breast cancer, she continues to serve as an inspiration to those who strive to maintain and broaden the relationships among these organizations. As a cancer survivor, Ms. Nealon tirelessly engendered changes at the National Institutes of Health, so that cancer patients could have an expanded role in the decision-making process at NCI. At a time when the consumer advocate’s voice was not widely heard as it is today in the realm of scientific discovery, Ms. Nealon graciously persuaded many in the scientific community to open their minds, eyes, and ears to those who are affected by the work done at NCI and in research laboratories across the U.S. Ms. Nealon embodied a compassionate, devoted personality. Her kindness, loyalty, sincerity, and integrity are sorely missed and will never be forgotten.

 

Office of Advocacy Relations - Building 31, Room 10A28 - 31 Center Drive, MSC 2580 - Bethesda, MD 20892-2580 - Phone: 301-594-3194 - Fax: 301-480-7558 - http://advocacy.cancer.gov

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