Provided by Meniscus Educational Institute and Meniscus Limited

Supported by an educational grant from Lilly USA, LLC. 

Release Date: March 2010

CE Available Until: March 31, 2011

Intended Audience
This continuing education activity is designed for oncology nurses and other healthcare providers interested in clinical trials for oncology patients

Learning Objectives
Module 1: Overview of Clinical Trials
At the completion of this activity, participants should be better able to  

• Describe the purpose of clinical trials
• Discuss regulatory and ethical considerations involved in conducting clinical trials
• Identify roles of members of the clinical research team

Module: 2: Phases of Clinical Trials  

• Identify the four phases of clinical trials
• Describe the function of a randomized clinical trial
• Define common study parameters used for patient evaluation in a Phase II study

Rationale and Purpose
Clinical trials are designed to test newly developed drugs, treatment regimens or medical devices in humans to assess safety, efficacy or clinical benefit. The primary aim of most clinical trials is to provide an unbiased evaluation of the merits of an investigational agent, regimen or device within a study population before being approved for wider use in the population of interest. Advances in cancer care and the development of more effective cancer therapeutics depend largely on an ef¬fective clinical trial process. Patient participation in clinical trials helps answer critical questions about cancer prevention and treatment. Adhering to a proven system of rigorous testing of new agents or new uses for existing therapies provides oncologists and oncology nurses with a solid base of evidence on which to base prevention, treatment and supportive care recommendations. The goal of this activity is to give oncology nurses an overview of the clinical trial process.

Continuing Education
Statement of Credit—To successfully complete this activity, you must review the content, score at least a 70% on the learning assessment, and submit your evaluation form. If you provide your e-mail address, you will receive an immediate e-mail notification with a link to your printable statement of credit.

  Nurses. This activity for 0.6 contact hours is provided by the Meniscus Educational Institute.

The Meniscus Educational Institute is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. 
Accreditation refers to recognition of educational activities only and does not imply approval or endorsement by the Meniscus Educational Institute or the American Nurses Credentialing Center’s Commission on Accreditation of any product mentioned.

Provider approved by the California Board of Registered Nursing, Provider No. 13164, for 0.6 contact hours.

Financial Disclosures
All individuals in positions to control the content of this program (eg, planners, faculty, content reviewers) are expected to disclose all financial relationships with commercial interests that may have a direct bearing on the subject matter of this continuing education activity. Participants have the responsibility to assess the impact (if any) of the disclosed information on the educational value of the activity. All faculty have been offered a modest honorarium from the accredited provider for their participation in this activity.

Susan Moore, RN, MSN, ANP, AOCN®, Advisory Panel, receives an honorarium from Genentech, Inc.
Pamela Hallquist Viale, RN, MS, CS, ANP, AOCNP®, Advisory Panel, receives honoraria from Bristol-Myers Squibb Company, Amgen Inc., Merck & Co., and Novartis Pharmaceuticals Corporation.
Carolyn Grande, MSN, CRNP, AOCNP®, Advisory Panel, receives an honorarium from IMER.
Linda J. Smith, MSN, MEd,  Project Director, has nothing to disclose.
Karen J. Abbas, RN, MS, AOCN®, Nurse Planner, has nothing to disclose.
Karen Dow Meneses, PhD, RN, FAAN, Content Reviewer, has nothing to disclose.
Linda Moriarty, RN, BSN, OCN®, Pilot Reviewer, receives honoraria from Merck & Co.
Dawn C. Stefanik, AA, MLT, BSN, RN, OCN®, Pilot Reviewer, has nothing to disclose.

Disclaimer
This activity has been designed to provide continuing education that is focused on specific objectives. In selecting educational activities clinicians should pay special attention to the relevance of those objectives and the application to their particular needs. The intent of all Meniscus Educational Institute educational opportunities is to provide learning that will improve patient care. Clinicians are encouraged to reflect on this activity and its applicability to their own patient population.

The opinions expressed in this activity are those of the faculty and reviewers and do not represent an endorsement by MEI of any specific therapeutics or approaches to diagnosis or patient management.

Product Disclosure
This educational activity may contain discussion of published and/or investigational uses of agents that are not approved by the US Food and Drug Administration. For additional information about approved uses, including approved indications, contraindications, and warnings, please refer to the prescribing information for each product or consult the latest edition of the Physicians’ Desk Reference.

There is no fee for participating in this activity.

ANCC Accreditation Feedback Line
1-866-262-9730

The Accreditation Program of the American Nurses Credentialing Center is interested in the opinions and perspectives of the participants in accredited continuing nursing education activities, particularly perspectives related to the presence of perceived bias* in an activity. For this reason, we provide a toll-free telephone number, which participants may call at any time to tell us about  

• Any noted bias or conflict of interest in the education
• Any concerns, compliments, or opinions
• A great experience
• An unpleasant experience
• Your thoughts on the process

Just call and tell us!
1-866-262-9730
*Bias is defined as preferential influence that causes a distortion of opinion or facts. Commercial bias may occur when an educational activity promotes one or more product(s) (drugs, devices, services, software, hardware, etc). This definition is not all inclusive, and participants may use their own interpretation in deciding whether a presentation is biased.
NOTE: statements of commercial support and/or conflict of interest disclosures do not represent bias. Such statements inform the learner that the provider has implemented a mechanism to identify and resolve all conflicts of interest prior to delivery of the educational material.

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