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...

New NIH Recovery Act Opportunity Seeks to Fund High Impact, Large-Scale, Accelerated Research (4/13/09)
Goal to Promote Growth and Investment in Biomedical R&D, Public Health and Health Care Delivery

The National Institutes of Health highlighted a new funding opportunity under the Recovery Act that will support approximately $200 million in large-scale research projects that have a high likelihood of enabling growth and investment in biomedical research and development, public health and health care delivery. The purpose of this new program, the Research and Research Infrastructure "Grand Opportunities" (GO), is to support high impact ideas that lend themselves to short-term funding and may lay the foundation for new fields of scientific inquiry. More information…

Recovery Act Funds for Administrative Supplements – Request for Applications – Nomination submission until May 1, 2009

Some funds directed to the National Cancer Institute (NCI) — through the American Recovery and Reinvestment Act of 2009 (“Recovery Act” or “ARRA”) — have been designated for an initiative known as the NCI-Activities to Promote Research Collaboration (NCI-APRC). Applications for these funds are due May 1, 2009. Through the NCI-APRC program, the NCI encourages requests for supplemental funding in FY2009 for existing NCI-funded research projects to support and encourage new multidisciplinary scientific collaborations among NCI grantees, as well as with other members of the scientific community. The NCI-APRC Program can support novel collaborative activities in cancer biology, cancer control and population sciences, cancer surveillance, cancer prevention, health services and outcomes research, and cancer treatment and diagnosis that bring together new ideas and approaches from disparate scientific disciplines. The proposed NCI-APRC activities must be within the overall scope of the active parent award and the collaborative activity must be new. For more information about NCI-ARPC, view the NCI-APRC Guidelines. For information on DCTD Strategic Research Interests, announced in February 2009, please see information on the DCTD Website. More information…

Visit NCI’s Website on Information about the American Recovery and Reinvestment Act of 2009.

AACR Highlights NCI Research Programs

Are you attending the American Association for Cancer Research (AACR) meeting?

If so, please stop by the NCI booth # 306 and pick up brochures highlighting NCI’s participation in various sessions throughout the conference. The brochures are entitled Guide to NCI Sessions on The Cancer Genome Atlas and the Guide to NCI-Sponsored Scientific and NCI Meet the Experts Sessions.

A Special Session: Address by the NCI Director,Dr. John E. Niederhuber, will be held on Monday, April 20 from 1:45 to 2:45 p.m. in the Korbel Ballroom. He will talk about opportunities to hasten progress against cancer and to conduct exciting new science, made possible, in part, by additional funding.

Other sessions include: Cancer Drug Development as a Successful Public-Private Enterprise—NCI in Partnership with Industry; Translating Knowledge from the Cancer Genome Atlas (TCGA) to Understand and Control Cancer; NCI Early Detection Research Network: Investment in Biomarker Research; and Proteomics Technology Platforms for the Cancer Biomarker Pipeline.

A series of “Meet the Experts” sessions will take place at the NCI booth. Below is a chart outlining the sessions to “tour” and discuss the NCI Funded Research Portfolio Web site.

NCI Interactive "Meet the Experts" Sessions
AACR 100th Annual Meeting 2009

Schedule for NCI Funded Research Portfolio (NFRP): Demo and Q/A
NCI Booth 306

Day/Date

Time

Presenter

Sunday, April 19

2:00 p.m.

Lisa Krueger, DEA

Monday, April 20

12:00 p.m.

Michele Vos, DEA

Monday, April 20

3:00 p.m.

Lisa Krueger, DEA

Tuesday, April 21

10:00 a.m.

Lisa Krueger, DEA

Tuesday, April 21

3:00 p.m.

Lisa Krueger, DEA

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.

TeleconferenceNCI Community Cancer Centers Program (NCCCP): Translating Scientific Advances into the Community, April 21, 2009, from 2:00-3:00 p.m. (ET)

Topic: The speakers will discuss how knowledge gained from NCI programs can be translated into a community setting

Speakers: Dr. Maureen Johnson, Project Officer, NCI Community Cancer Centers Program and Dr. Beverly Laird, Co-Chair NCI Directors’ Consumer Liaison Group

USA Toll-Free: 1-800-857-6584         Passcode: NCCCP
Toll-Free Playback: 1-866-457-5714 through May 21, 2009
For more information: http://ncccp.cancer.gov/

WebinarPromise and Reality of Proteomics Webinar Replay Available

The National Cancer Institute (NCI) Office of Advocacy Relations invites you to view this Webinar on the role of protein science in the early detection of cancer as part of the Understanding NCI: Toll-Free Teleconference Series.

Topic: The speakers addressed how the biomarker discovery pipeline can turn discoveries into clinical use.

Speakers:

  • Dr. Henry Rodriguez, Director, Clinical Proteomic Technologies for Cancer, NCI Office of Technology and Industrial Relations
  • Dr. Amanda Paulovich, Director of the Fred Hutchinson Cancer Research Center’s Early Detection Initiative
  • Ms. Elda Railey, Co-Founder of Research Advocacy Network

Click here to view webinar.

NCI Plans Next Steps for Dissemination and Outreach

Last year, the National Cancer Institute’s Office of Advocacy Relations facilitated a teleconference for stakeholders on NCI’s decision not to renew the contract for the Cancer Information Service Partnership Program when it expires in January of 2010.

NCI’s priority is to serve those touched by cancer in communities across the country, with special attention toward the medically underserved, and the organizations whose direct attention is reaching these communities.

NCI’s next steps toward developing a concept for a dissemination and outreach arm are in progress. Various stakeholders will be included in each step of the process. Community members will be updated and asked for input through teleconferences, webinars and other forms of engagement. The planning process will utilize evidence and data in considering:

  • areas that are the most vulnerable to the poorest cancer outcomes;
  • opportunities where intervening in specific ways have the greatest potential for improving outcomes;
  • metrics that can be put in place to determine the outcomes of activities on cancer control; and
  • partnerships with other Federal agencies and key stakeholders to achieve greatest impact.

NCI will convene an independent panel of experts for synthesis and interpretation of the evidence. They will represent the fields of public health, advocacy, partnership development, cancer disparities, comprehensive cancer control, communications, dissemination, outreach, and social justice.

TeleconferenceNCI Co-Sponsors 7th Annual Survivorship Series with CancerCare and LAF
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

This workshop is 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.

Cancer News

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Maintenance Rituximab May Improve Survival in Follicular Lymphoma (4/02/09)

In a pooled analysis of data from five clinical trials in patients with follicular lymphoma whose disease had relapsed or was resistant to treatment, those who received maintenance therapy with rituximab survived longer than those who did not receive maintenance therapy. However, this finding leaves unanswered the question of whether maintenance rituximab is superior to treatment with rituximab on relapse. Read more…

NIH News in Health - Study Questions Prostate Cancer Test (4/09)

The prostate-specific antigen (PSA) test can spot prostate cancer early. But surprisingly, annual PSA tests may not lead to fewer prostate cancer deaths, a new study suggests. Read more…

Public Health Cancer News

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First Phase 0 Oncology Trial Shows Effectiveness of New Drug on Its Target (4/12/09)

The first phase 0 clinical trial of a drug in cancer treatment, involving 13 patients with advanced cancers, showed that the drug, ABT-888, affected its target and was well tolerated. Most importantly, this trial showed that it is possible to enroll a small number of patients, treat them with a low dose of a new drug, identify whether the desired target of the drug was affected, and obtain all of this critical information relatively quickly. Read more…

More Cancer from Smoking (4/09/09)

What cancer does smoking cause? Lung cancer is one clear answer. But a researcher thinks this may underestimate the impact of cancer. Bruce Leistikow of the University of California, Davis, bases that on a review of data on men living in Massachusetts from 1979 to 2003. Read more…

Reprogrammed Human Stem Cells Clear Another Hurdle (4/06/09)

Researchers have developed a technique in which the genes used to reprogram human cells and give them the versatility of embryonic stem cells can be cleanly removed afterward. The advance takes researchers another major step toward creating cells that could potentially be used for human therapies. Read more…

NIH News in Health - Get Moving and Stay Healthy (4/09)

Those busy with work and school, two-career couples, single parents—really, whoever you are, people from all walks of life find it difficult to get enough exercise. But research shows that all Americans need physical activity for good health. New government guidelines can help you get started and stay active. Read more…

Policy News

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Medicare Expands Coverage of PET Scans as Cancer Diagnostic Tool (4/06/09)

The Centers for Medicare & Medicaid Services issued a final national coverage determination to expand coverage for initial testing with positron emission tomography (PET) for Medicare beneficiaries who are diagnosed with and treated for most solid tumor cancers. Read more…

Fact Sheets, Websites, & Publications

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New Drug Information Summary for Bleomycin (4/14/09)

Bleomycin is approved by the Food and Drug Administration (FDA) to treat malignant pleural effusion and keep it from recurring (coming back). Bleomycin is also approved to be used alone or with other drugs as palliative treatment for many types of cancer. View Drug Information Summary…

NIH Launches New Clinical Research Web site (4/10/09)

The new Clinical Research Web site provides information on how clinical research is conducted and the role that clinical trial participants play in the process. There are personal testimonies of volunteers who have participated in clinical research as well as a state by state breakdown of NIH research funding. Visit Website…

Fact Sheet – Prostate Cancer Research Results From the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial (4/02/09)

The Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial, or PLCO, is a large-scale clinical trial to determine whether certain cancer screening tests reduce the number of deaths from these cancers. Screening for cancer may enable doctors to discover and successfully treat the disease earlier, preventing deaths. View Fact Sheet…

Spotlight on Women’s Health – Kris Carr: Interview with a Woman Living with Cancer (4/02/09)

Faced with the diagnosis of cancer, Kris Carr refused to go down without a fight. Her quest for information and no-nonsense attitude empowered her to become an advocate for her own health. In doing so, she created a documentary, wrote several books, and developed a blog and an online community. Read more…

Health Literacy, eHealth, and Communication: Putting the Consumer First Workshop Summary (4/02/09)

There is great enthusiasm over the use of emerging interactive health information technologies—often referred to as eHealth—and the potential these technologies have to improve the quality, capacity, and efficiency of the health care system. eHealth includes such technologies as electronic personal health records; electronic health education libraries; and online personal health journals and self-assessment tools. Read more…

NIH News in Health Issue (4/09)

The April 2009 issue is now available! Read about making physical activity part of your life and remembering to take your pills. View current issue…

New Oral Cancer Materials for African American Men Now Available (4/09)

African American men have a higher risk of developing oral cancer than any other group in the U.S. population. To help raise awareness of this risk and the importance of early detection, National Institute of Dental and Craniofacial Research (NIDCR), in partnership with the National Cancer Institute (NCI), developed a new publication series, “Oral Cancer: What African American Men Need to Know.” Read more….

New Fact Sheet on Brain and Other Central Nervous System Cancers (4/09)

In 2005, the age-adjusted incidence of brain and other central nervous system (CNS) cancers among adults was 6.5 per 100,000 persons; among children 19 years of age or younger it was 2.8 per 100,000. The higher incidence rates observed today are likely due, in part, to an improved ability to diagnose brain and other CNS tumors with advanced imaging technologies. View Fact Sheet…

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 – Public Meeting on ClinicalTrials.gov (4/20/09) Bethesda, MD

The National Institutes of Health (NIH) of the U.S. Department of Health and Human Services (HHS) is holding a public meeting and requesting input from interested parties on issues that the agency will consider as it develops regulations to expand the clinical trial registry and results data bank commonly known as ClinicalTrials.gov. Comments on these issues from all interested parties will inform the development of draft regulations, which will be made available for public comment via a Notice of Proposed Rulemaking (NPRM) that will be issued in the Federal Register at a later date. More information…

Meeting – Secretary’s Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020 (4/20/09) Online

The Committee will meet on the Internet via WebEx software. The meeting will be open to the public as a live, streaming webcast. All interested parties are invited to committee meetings. While the main focus of the meeting will be on Committee discussion, an opportunity will be provided for members of the public to provide oral comments to the Committee. More information…

Meeting – Advisory Panel on Medicare Education (4/22/09) Washington, D.C.

The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. The agenda includes discussion of Medicare outreach and education strategies, public comment, and a listening session with CMS leadership. More information…

Public Comment – Cancer Focus and Objectives for Healthy People 2020 – Comments to be submitted by April 24, 2009

The 2010 Healthy People objectives for cancer were within the following focus areas: overall cancer deaths, lung cancer deaths, breast cancer deaths, cervical cancer deaths, colorectal cancer deaths, oropharyngeal cancer deaths, prostate cancer deaths, melanoma deaths, sun exposure and skin cancer, provider counseling about cancer prevention, Pap tests, colorectal cancer screening, mammograms, statewide cancer registries, and cancer survival.

In preparation for the process of creating draft objectives for Healthy People 2020, we are seeking preliminary comments on existing Healthy People 2010 objectives. Comments received by April 24 will be considered as we create the draft objectives for Healthy People 2020. This is a preliminary input period that will help inform the development of a set of draft Healthy People 2020 objectives.

Submit comments by April 24, 2009, online. More information…

Public Comment – Systematic Review of Topographic Genotyping Available for Comment – Comments to be submitted by April 24, 2009

The Agency for Healthcare Research and Quality's (AHRQ) Technology Assessment Program develops systematic reviews, health technology assessments, and other reports at the request of the Centers for Medicare & Medicaid Services (CMS) Coverage and Analysis Group. These reports are used to inform national coverage policies and for discussion at public Medicare Evidence Development and Coverage Advisory Committee (MedCAC) meetings.

The systematic review posted for public comment is of the published literature on PathfinderTG®, a patented technology for topographic genotyping offered by the private company RedPath Integrated Pathology Inc. Topographic genotyping integrates anatomic pathology done microscopically and molecular analyses. Briefly, it involves performing microscopic examination of a specimen, identifying areas of interest on the pathology slide, and microdissecting (manually excising) them under the microscope. The minute tissue samples, enriched in tumor cells, can then be subjected to molecular analyses. It has been claimed that topographic genotyping can aid pathologic diagnosis, individualize prognosis and guide treatment decisions. The aim of the systematic review is to describe the published evidence on the analytic validity of PathfinderTG®, as well as the published evidence on its clinical validity and utility.

Submit comments by April 24, 2009, online. More information…

Request for Nominations – Two Patient Advocates Needed for the Medicare Evidence Development & Coverage Advisory Committee – Nomination submission until April 27, 2009

The MEDCAC advises the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on whether medical items and services are "reasonable and necessary" and therefore eligible for coverage under Title XVIII of the Social Security Act. The MEDCAC reviews and evaluates medical literature, reviews technology assessments, and examines data and information on the effectiveness and appropriateness of medical items and services that are covered or eligible for coverage under Medicare.

The MEDCAC consists of a pool of 100 appointed members including 6 patient advocates, who are standard voting members. As of May 2009 there will be 2 vacancies on MEDCAC for patient advocates.

Nominations for membership must be postmarked by April 27, 2009 and mailed to Maria Ellis, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail Stop: C1-09-06, Baltimore, MD 21244-1850. More information…

Meeting – Neuropathic Cancer Pain Symposium (4/27/09) Bethesda, MD
Advocates invited to attend! Register Today

The National Cancer Institute and the National Institutes of Health Pain Consortium invites you to attend the Trans-NIH Neuropathic Cancer Pain Symposium to be held on April 27, 2009 in Bethesda, Maryland.

The Neuropathic Cancer Pain Symposium will bring together a multi-disciplinary group of researchers, clinicians, and patient advocates to build upon our knowledge and understanding of the role of pain and pain management in cancer care. This symposium seeks to address the knowledge gap in the area of neuropathic pain associated with cancer, due to the underlying disease, as well as therapy. Planners aim to develop a symposium report, a synopsis of which could be published in a peer-review journal as a call-to-action to government, industry, clinicians, and others.

The day will include plenary sessions, panel discussions and opportunities for networking. Advocates are invited to contribute to the Q&A session following each panel discussion. Registration is free and space is extremely limited. More information…

Please contact Camilla Benedicto of the NCI Office of Advocacy Relations at (301) 402-5575 or by email with any questions or for more information.

Meeting – FDA Pediatric Advisory Committee and Oncologic Drugs Advisory Committee: Joint Meeting (4/27/09) Gaithersburg, MD

The Pediatric Advisory Committee and the Oncologic Drugs Advisory Committee will meet to discuss the scientific and ethical issues involved in obtaining and using brain biopsy specimens to evaluate gene expression patterns in children with diffuse pontine gliomas. More information…

Meeting – Dietary Guidelines Advisory Committee Meeting (4/29/09-4/30/09) Online

The meeting will (a) include presentations by expert speakers on topics that may include the eating environment, economics and nutrient adequacy, and effects of various macronutrient meal plans on weight status; (b) allow individual subcommittees to provide updates on progress made within each subcommittee; and (c) allow for the continued formulation of plans for future work of the Committee. After a thorough review of the most current scientific and applied literature and open Committee deliberations, the Committee will provide its recommendations in the form of an advisory report to the Secretaries of both Departments. Online registration is requested. More information…

Meeting – Healthy People 2010 Regional Public Meeting (4/30/09) Chicago, IL

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 – FDA Risk Communication Advisory Committee (4/31/09-5/01/09) Rockville, MD

On both days the Committee will discuss the Agency's draft risk communication strategic plan and will be asked for comment and further advice, for example, on strategic priorities for research on effective risk communication. More information…

Meeting – Economically Motivated Adulteration of Food or Drugs (5/01/09) College Park, MD

The purpose of the meeting is to stimulate and focus a discussion about ways in which the food, (including dietary supplements and animal food), drug, medical device and cosmetic industries, regulatory agencies, and other parties can better predict and prevent economically motivated adulteration. FDA invites interested individuals, organizations, and other stakeholders, including industry representatives, to present information pertaining to predicting and preventing EMA of food, (including dietary supplements and animal food), drugs, medical devices and cosmetics. More information…

Meeting – Medicare Evidence Development and Coverage Advisory Committee (5/06/09) Baltimore, MD

This meeting will focus on the requirements for evidence to determine if the use of screening genetic testing of beneficiaries without signs or symptoms of disease improves health outcomes in Medicare beneficiaries. The meeting will discuss the various kinds of evidence that are useful to support requests for Medicare coverage in this field. More information…

Meeting – Advisory Council on Blood Stem Cell Transplantation (5/12/09) Bethesda, MD

The Council will hear reports from three ACBSCT Work Groups: Cord Blood Accreditation Organization and Recognition Process, Scientific Factors Necessary to Define a Cord Blood Unit as High Quality, and Informed Consent. The Council also will hear presentations and discussions on the following topics: recent clinical developments and current issues, adult donor recruitment: Strategies and challenges, and future council activities. More information…

Meeting – Healthy People 2010 Regional Public Meeting (5/14/09) New York, NY

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…

Conference – Reducing Regulatory Burden: Real Strategies for Real Change
Office for Human Research Protections (5/14/09) Ann Arbor, MI

Interested in sharing ideas on how to change or eliminate Institutional Review Board (IRB) processes while maintaining high standards for protection of human subjects? Register for this one-day program to learn about: ways to better use the flexibility within regulations, proposed changes to the regulations, novel approaches to IRB activities, and demonstrations on decreasing regulatory burdens for PIs and IRBs. The target audience includes institutional officials, institutional administrators, principal investigators, research staff, research coordinators, legal counsel, public health officials, privacy officers, compliance officers, patient advocates and IRB members, administrators, coordinators, and staff. More information…

Conference – Improving Health WITH Communities: The Role of Community Engagement in Clinical and Translational Research (5/14/09 – 5/15/09) Bethesda, MD

This event is free and open to the public. This is the second annual conference to discuss and share best practices and collaborate with communities and health care providers to improve health. Participants will develop recommendations for academic-community collaborations and partnerships with other community programs to establish research agendas. Discussions will include ways to transform the clinical research enterprise through effective collaboration. Best practices, effective collaboration strategies and successful models will be discussed and shared. More information…

Public Comment - Patient Access to Genetic Tests: How Gene Patents and Licensing Practices Impact Access – Comments must be submitted by May 15, 2009.

The Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) is requesting public comments on a draft report to the Secretary of Health and Human Services, "Public Consultation Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests." The draft report includes policy options. The Committee developed these options to present a broad range of possible actions, but has not yet decided which, if any, of these policy options to support.

Before SACGHS can develop specific recommendations for the Secretary, the Committee needs public input on several issues, including whether changes are needed in patenting and licensing practices that affect genetic testing, and the appropriateness, feasibility, and implications of the report's policy options. Members of the public are also invited to recommend specific policy options not included in the presented options and any needed modifications to existing options. SACGHS also encourages the public to provide any additional information and data regarding the positive or negative effects gene patenting or licensing practices have had, are having, or may have on patient and clinical access to genetic tests.

Submit comments by May 15, 2009, by email with the subject line SACGHS Public Comment. More information…

Meeting – Secretary’s Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020 (5/15/09) Online

The Committee will meet on the Internet via WebEx software. The meeting will be open to the public as a live, streaming webcast. All interested parties are invited to committee meetings. While the main focus of the meeting will be on Committee discussion, an opportunity will be provided for members of the public to provide oral comments to the Committee. 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…

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…

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 – National Advisory Council for Complementary and Alternative Medicine Meeting (6/05/09) 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…

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 – 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…

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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Great Teachers – Hereditary Cancer Predisposition: New Challenges

Wednesday, April 08, 2009
Judy E. Garber, MD, MPH
Total Running Time: 00:52:54

Demystifying Medicine – Drug resistance and cancer

Tuesday, April 07, 2009
Michael Gottesman, MD and Susan Bates, MD
Total Running Time: 02:00:00

Nanotechnology at NIH: Basic Concepts, Current Research, and Medical Applications

Tuesday, April 07, 2009
Trans-NIH Nanotechnology Task Force and NIH Roadmap Nanomedicine Initiative
Total Running Time: 06:38:34

An Ubiquitous Reserve of Multipotent Stem Cells in the Walls of Blood Vessels

Monday, April 06, 2009
Bruno Péault, Ph.D.
Total Running Time: 01:09:15

DNA Replication: Start Right, Proceed with Caution

Mirit Aladjem, Ph.D., Laboratory of Molecular Pharmacology, NCI
Total Running Time: 00:54:01

Featured Clinical Trials

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Lymphoma Cancer Clinical Trial Continues at NCI’s Center for Cancer Research at NIH in Bethesda, Maryland.

Why is this phase I/II trial for lymphoma cancer important?

This study aims to determine the highest dose of ABT-263 that can safely be given to patients with lymphoma while evaluating the safety and effectiveness of ABT-263 in treating patients with lymphoma that has recurred (come back) or is refractory (did not respond to prior treatment). In addition, we hope to determine how the body absorbs and handles ABT-263. Finally, we hope to find biomarkers (substances in the blood or tissue that may indicate the effects or progress of the disease and activity of ABT-263). For more information about this trial, please visit: http://bethesdatrials.cancer.gov/ola/wilson/07c0006/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.

 

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