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Notes

Marie Bakits, DNSc, APRN Co-Author for Palliative Care Research Project
Effects of a Palliative Care Intervention on Clinical Outcomes in Patients with Advanced Cancer
The Project ENABLE II Randomized Controlled Trial
This research project was recently published in JAMA and here is the link for those interested... http://jama.ama-assn.org/cgi/reprint/302/7/741

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January 28, 2012




Clinical Trial Nurses SIG

On this SIG Virtual Community page, you will find information pertaining the Clinical Trial Nurses SIG. Here, you can view myriad resources, download and complete pertinent documents, join in our discussions and much more. Welcome to our SIG Virtual Community.

Announcements
Click here to sign up for SIG Announcements.

Oncology Clinical Trials Nurse Competencies:  In 2010, ONS released competencies for the Clinical Trials Nurse. These competencies outline the fundamental knowledge, skills and expertise required for novice clinical trials nurses to proficiently perform in this role during their first one to two years as a CTN. 

CTN SIG is now on Facebook! 
..........

Clinical Trials Resource Area
The conduct of clinical trials is the way we investigate scientific advances in oncology. It is the machine which moves our knowledge forward. Cancer nurses are critical to this research process, involved in designing and operationalizing research studies, protecting the rights of patients who choose to participate in research, and safely delivering the treatments. Working in the complex field of cancer research requires advanced knowledge in oncology, excellent patient/family teaching skills, a thorough work ethic, and the ability to work collaboratively with many different kinds of professional staff. The work is cutting edge, exciting and challenging.

Slides from Previous Congress sessions
Slides from Congress Session (2011): Development of the CTN Competenices including examples of implementation (2011)
Slides from CTN SIG presentation (2011): ORN-WAT: Oncology Research Nurse - Workload Assessment Tool
Cost Coverage and Implications for the Clinical Trials Nurse
(2010)

Clinical Trials Nurse Job Opportunity



REQUEST FOR NOMINATIONS FOR MEMBERS FOR THE MEDICARE EVIDENCE DEVELOPMENT & COVERAGE ADVISORY COMMITTEE POSTMARKED BY MON JANUARY 30, 2012

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services [CMS-3254-N] Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Notice.

SUMMARY: This notice announces the request for nominations for membership on the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Among other duties, the MEDCAC provides advice and guidance to the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) concerning the adequacy of scientific evidence available to CMS for "reasonable and necessary" determinations under Medicare. We are requesting nominations for both voting and nonvoting members to serve on the MEDCAC. Nominees are selected based upon their individual qualifications and not as representatives of professional associations or societies. We wish to ensure adequate representation of the interests of both women and men, members of all ethnic groups and physically challenged individuals. Therefore we encourage nominations of qualified candidates who can represent these interests. The MEDCAC reviews and evaluates medical literature, technology assessments, and hears public testimony on the evidence available to address the impact of medical items and services on health outcomes of Medicare beneficiaries. CMS-3254-N 2

DATES: Nominations will be considered if postmarked by Monday, January 30, 2012 and mailed to the address specified in the ADDRESSES section of this notice.

ADDRESSES: You may mail nominations for membership to the following address: Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, Attention: Maria Ellis, 7500 Security Boulevard, Mail Stop: South Building 3-02-01, Baltimore, MD 21244.

FOR FURTHER INFORMATION CONTACT: Maria Ellis, Executive Secretary for the MEDCAC, Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, Coverage and Analysis Group, S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 or contact Ms. Ellis by phone (410-786-0309) or via e-mail at Maria.Ellis@cms.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

The Secretary signed the initial charter for the Medicare Coverage Advisory Committee (MCAC) on November 24, 1998. A notice in the Federal Register (63 FR 68780) announcing establishment of the MCAC was published on December 14, 1998. The MCAC name was updated to more accurately reflect the purpose of the committee and on January 26, 2007, the Secretary published a notice in the Federal Register (72 FR 3853), announcing that the Committee's name changed to the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). The charter for the committee was renewed by the Secretary on November 24, 2010. The current charter is effective for 2 years. CMS-3254-N 3 The MEDCAC is governed by provisions of the Federal Advisory Committee Act, Pub. L. 92-463, as amended (5 U.S.C. App. 2), which sets forth standards for the formulation and use of advisory committees, and is authorized by section 222 of the Public Health Service Act as amended (42 U.S.C. 217A). The MEDCAC consists of a pool of 100 appointed members including: 94 voting members of whom 6 are designated patient advocates, and 6 nonvoting representatives of industry interests. Members generally are recognized authorities in clinical medicine including subspecialties, administrative medicine, public health, biological and physical sciences, epidemiology and biostatistics, clinical trial design, health care data management and analysis, patient advocacy, health care economics, medical ethics, or other relevant professions. The MEDCAC works from an agenda provided by the Designated Federal Official. The MEDCAC reviews and evaluates medical literature, technology assessments, and hears public testimony on the evidence available to address the impact of medical items and services on health outcomes of Medicare beneficiaries. The MEDCAC may also advise CMS as part of Medicare's "coverage with evidence development" initiative.

II. Provisions of the Notice

As of June 2012, there will be 30 membership terms expiring. Of the 30 memberships expiring, 1 is a nonvoting industry representative, 4 are voting patient advocates and the remaining 25 membership openings are for the general MEDCAC voting membership. CMS-3254-N 4 Accordingly, we are requesting nominations for both voting and nonvoting members to serve on the MEDCAC. Nominees are selected based upon their individual qualifications and not as representatives of professional associations or societies. We wish to ensure adequate representation of the interests of both women and men, members of all ethnic groups and physically challenged individuals. Therefore, we encourage nominations of qualified candidates from these groups. All nominations must be accompanied by curricula vitae. Nomination packages must be sent to Maria Ellis at the address listed in the ADDRESSES section of this notice. Nominees for voting membership must also have expertise and experience in one or more of the following fields:

• Clinical medicine including subspecialties

• Administrative medicine

• Public health

• Biological and physical sciences

• Epidemiology and biostatistics

• Clinical trial design

• Health care data management and analysis

• Patient advocacy

• Health care economics

• Medical ethics

• Other relevant professions

We are looking for experts in a number of fields. Our most critical needs are for experts in hematology; genomics; Bayesian statistics; clinical epidemiology; clinical trial CMS-3254-N 5 methodology; knee, hip, and other joint replacement surgery; ophthalmology; psychopharmacology; rheumatology; screening and diagnostic testing analysis; and vascular surgery. We also need experts in biostatistics in clinical settings, cardiovascular epidemiology, dementia, endocrinology, geriatrics, gynecology, minority health, observational research design, stroke epidemiology, and women's health. The nomination letter must include a statement that the nominee is willing to serve as a member of the MEDCAC and appears to have no conflict of interest that would preclude membership. We are requesting that all curricula vitae include the following:

• Date of birth

• Place of birth

• Social security number

• Title and current position

• Professional affiliation

• Home and business address

• Telephone and fax numbers

• E-mail address

• List of areas of expertise

In the nomination letter, we are requesting that the nominee specify whether they are applying for a voting patient advocate position, for another voting position, or as a nonvoting industry representative. Potential candidates will be asked to provide detailed information concerning such matters as financial holdings, consultancies, and research grants or contracts in order to permit evaluation of possible sources of conflict of interest. CMS-3254-N 6 Members are invited to serve for overlapping 2-year terms. A member may serve after the expiration of the member's term until a successor is named. Any interested person may nominate one or more qualified persons. Self-nominations are also accepted. The current Secretary's Charter for the MEDCAC is available on the CMS website at: http://www.cms.hhs.gov/FACA/Downloads/medcaccharter.pdf, or you may obtain a copy of the charter by submitting a request to the contact listed in the FOR

FURTHER INFORMATION section of this notice. CMS-3254-N

Authority: 5 U.S.C. App. 2, section 10(a)(1) and (a)(2). (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare--Supplementary Medical Insurance Program.)

Dated: October 18, 2011

___________________________

Patrick Conway

CMS Chief Medical Officer and Director

Office of Clinical Standards and Quality

Centers for Medicare & Medicaid Services

BILLING CODE: 4120-01-P

[FR Doc. 2011-29784 Filed 11/17/2011 at 8:45 am; Publication Date: 11/18/2011]



Become An Effective Clinical Trials Nurse

Shedding Light on Clinical Research: An Introduction to Clinical Trials Nursing is a motivating new online course for oncology nurses interested in clinical trials. This course provides a combination of didactic content and activities to help you gain the experience required for success as a clinical trials nurse. By the end of the course, you will have a good understanding of how to implement a clinical research protocol. This course is ideal for nurses with less than two years of experience in a CTN setting; established CTNs looking for an up-to-date refresher course; and for those considering a position in clinical trials nursing.



Summit Series on Cancer Clinical Trials Task Force on Human Subject Protections

Interorganizational Liaison Report



Clinical Trial Nurses Announcements

 
Post new announcement | Subscribe to list

Announcement Posted By Date Posted
Lists for all the Industries - 2011 guest 12/8/11
Newsletter from PMB ermeter 11/7/11
AdEERS Training site change ermeter 11/3/11
Clinical Trial Nurse Clinicians Needed! onsseeker 8/27/11
Healthcare Industry Professionals Databases guest 8/24/11
Investigational New Drug Safety Reporting Requirements ermeter 3/28/11
The FDA has issued a final rule that goes into effect on March 28, 2011 affecting expedited AE reporting. ermeter 3/2/11
House Approves Bill to Cut NIH Funding By $1.6 Billion for Remainder of FY 2011; Contact Your Senators Now to Protect NIH Funding ermeter 3/1/11
Legal Resource Guide for Health Professionals ermeter 1/8/11
FDA Requires new informed consent elements ermeter 1/8/11
AccrualNet: ermeter 5/9/10
Oncology Clinical Trials Nurse Competencies ermeter 2/1/10
Post by email:  Email list address for this Announcements list is
clinicaltrial-announcements@lists.ons.org
Any emails sent to this address will be delivered to all list subscribers.

IOM HIPAA Report Release

Dear Members, Partners, and Friends,

The Institute of Medicine has released its latest report,
Beyond the HIPAA Policy Rule: Enhancing Privacy, Improving Health Through Research. As a member of and contributor to the National Cancer Policy Forum, C-Change helped sponsor the work of the IOM on this important issue. The report concludes that the HIPAA Privacy Rule does not protect privacy as well as it should and that, as implemented, it impedes important research. The report offers a new approach to privacy protection in research, as well as recommendations for revising the HIPAA Privacy Rule should a new approach not be taken. This issue is important to address both in terms of research and in the context of the national discussion around health access that is gaining momentum. We strongly encourage you to review the findings in the report and to make your voices heard on this issue in the coming months. Tom's signature dark

Tom Kean
Executive Director



Final Draft of Cancer Program Standards Available for Public Comment

The American College of Surgeons Commission on Cancer (CoC) is in the final stages of compiling its new standards manual: Cancer Program Standards 2012: Ensuring Patient-Centered Care, which is scheduled for release in July 2011. Diane M. Otte, RN, MS, OCN®, the ONS liaison to the CoC, reports that the new standards focus on quality, patient-centered care, addressing key issues such as psychological distress, patient navigation, palliative care, and survivorship, among others.

The standards continue to be open for public comment while the CoC pilot tests them in 50 different survey sites. To provide feedback, use the 2012 Cancer Program Standards wiki on the CoC website.

The CoC will use several methods to educate and disseminate the standards, including a webcast series scheduled for April, YouTube videos dedicated to each of the 34 standards in August/September, and use of a new Best Practices Repository to be available in September. The guidelines will be effective beginning January 2012.

The CoC Accreditation Program is a voluntary commitment designed to encourage hospitals, treatment centers, and other facilities to provide quality care. Programs undergo evaluation and review every three years. According to its website, more than 1,480 CoC-accredited programs diagnose and treat 80% of newly diagnosed patients annually.

The CoC’s Cancer Program Standards are updated every 5-7 years to reflect changes in cancer care. The current standards were last completely revised in 2004.



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