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Medscape, LLC, encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration, at first mention and where appropriate in the content.

Authors

Leonard Sacks, MD

Acting Director, Office of Critical Path Programs, US Food and Drug Administration, Silver Spring, Maryland

Disclosures

Disclosure: Leonard Sacks, MD, has disclosed no relevant financial relationships.

Dr. Sacks does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the US Food and Drug Administration (FDA) for use in the United States.

Dr. Sacks does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Robert L. Coleman, MD

Professor of Gynecologic Oncology, Vice Chair of Clinical Research, University of Texas, MD Anderson Cancer Center, Houston, Texas

Disclosures

Disclosure: Robert L. Coleman, MD, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: BiPar Sciences; sanofi-aventis; Endocyte; Nektar Therapeutics; GlaxoSmithKline; AstraZeneca Pharmaceuticals LP; Morphotek, Inc.; Genentech, Inc.; Roche; Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; Merck & Co., Inc.; Boehringer Ingelheim Pharmaceuticals, Inc.
Received grants for clinical research from: Merck & Co., Inc.; Abbott Laboratories; Boehringer Ingelheim Pharmaceuticals, Inc.; Abraxis Oncology; Regeneron Pharmaceuticals, Inc.; sanofi-aventis; Novartis Pharmaceuticals Corporation; Genentech, Inc.

Dr. Coleman does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr. Coleman does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Kenneth Getz, MBA

Senior Research Fellow, Tufts Center for the Study of Drug Development; Founder and Chairman, Center for Information and Study on Clinical Research Participation; Founder and Owner, CenterWatch, Boston, Massachusetts

Disclosures

Disclosure: Kenneth Getz, MBA, has disclosed no relevant financial relationships.

Mr. Getz does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Mr. Getz does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Frederick P. Ognibene, MD

Deputy Director, Educational Affairs and Strategic Partnerships, National Institutes of Health Clinical Center, Bethesda, Maryland

Disclosures

Disclosure: Frederick P. Ognibene, MD, has disclosed no relevant financial relationships.

Dr. Ognibene does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr. Ognibene does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Editor

Sarah Williams, PhD

Scientific Director, Medscape, LLC

Disclosures

Disclosure: Sarah Williams, PhD, has disclosed no relevant financial relationships.

CME Reviewer

Nafeez Zawahir, MD

CME Clinical Director, Medscape, LLC

Disclosures

Disclosure: Nafeez Zawahir, MD, has disclosed no relevant financial relationships.

Nurse Planner

Laurie E. Scudder, DNP, NP

Nurse Planner, Continuing Professional Education Department, Medscape, LLC; Clinical Assistant Professor, School of Nursing and Allied Health, George Washington University, Washington, DC

Disclosures

Disclosure: Laurie E. Scudder, DNP, NP, has disclosed no relevant financial relationships.

CME/CE

Transforming a Clinician Into an Investigator: What Does It Take?

Authors: Leonard Sacks, MD; Robert L. Coleman, MD; Kenneth Getz, MBA; Frederick P. Ognibene, MD
CME/CE Released: 11/15/2011
THIS ACTIVITY HAS EXPIRED FOR CREDIT
Valid for credit through: 11/15/2012, 11:59 PM EST

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Target Audience and Goal Statement

This activity is intended for clinicians who are interested in learning about clinical trials.

The goal of this activity is to help educate clinicians about clinical trials, particularly the responsibilities of clinical investigators.

Upon completion of this activity, participants will be able to:

Summarize the major responsibilities of the clinical trial investigator in the United States
Outline the challenges facing clinical trial investigators
Identify strategies for overcoming barriers to participating as clinical investigators

Disclosures

Authors

Leonard Sacks, MD

Acting Director, Office of Critical Path Programs, US Food and Drug Administration, Silver Spring, Maryland

Disclosures

Disclosure: Leonard Sacks, MD, has disclosed no relevant financial relationships.

Dr. Sacks does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the US Food and Drug Administration (FDA) for use in the United States.

Dr. Sacks does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Robert L. Coleman, MD

Professor of Gynecologic Oncology, Vice Chair of Clinical Research, University of Texas, MD Anderson Cancer Center, Houston, Texas

Disclosures

Disclosure: Robert L. Coleman, MD, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: BiPar Sciences; sanofi-aventis; Endocyte; Nektar Therapeutics; GlaxoSmithKline; AstraZeneca Pharmaceuticals LP; Morphotek, Inc.; Genentech, Inc.; Roche; Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; Merck & Co., Inc.; Boehringer Ingelheim Pharmaceuticals, Inc.
Received grants for clinical research from: Merck & Co., Inc.; Abbott Laboratories; Boehringer Ingelheim Pharmaceuticals, Inc.; Abraxis Oncology; Regeneron Pharmaceuticals, Inc.; sanofi-aventis; Novartis Pharmaceuticals Corporation; Genentech, Inc.

Dr. Coleman does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr. Coleman does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Kenneth Getz, MBA

Senior Research Fellow, Tufts Center for the Study of Drug Development; Founder and Chairman, Center for Information and Study on Clinical Research Participation; Founder and Owner, CenterWatch, Boston, Massachusetts

Disclosures

Disclosure: Kenneth Getz, MBA, has disclosed no relevant financial relationships.

Mr. Getz does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Mr. Getz does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Frederick P. Ognibene, MD

Deputy Director, Educational Affairs and Strategic Partnerships, National Institutes of Health Clinical Center, Bethesda, Maryland

Disclosures

Disclosure: Frederick P. Ognibene, MD, has disclosed no relevant financial relationships.

Dr. Ognibene does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved by the FDA for use in the United States.

Dr. Ognibene does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.

Editor

Sarah Williams, PhD

Scientific Director, Medscape, LLC

Disclosures

Disclosure: Sarah Williams, PhD, has disclosed no relevant financial relationships.

CME Reviewer

Nafeez Zawahir, MD

CME Clinical Director, Medscape, LLC

Disclosures

Disclosure: Nafeez Zawahir, MD, has disclosed no relevant financial relationships.

Nurse Planner

Laurie E. Scudder, DNP, NP

Nurse Planner, Continuing Professional Education Department, Medscape, LLC; Clinical Assistant Professor, School of Nursing and Allied Health, George Washington University, Washington, DC

Disclosures

Disclosure: Laurie E. Scudder, DNP, NP, has disclosed no relevant financial relationships.

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For Physicians

Medscape, LLC is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Medscape, LLC designates this enduring material for a maximum of 0.75 AMA PRA Category 1 Credit(s)™ . Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Medscape, LLC staff have disclosed that they have no relevant financial relationships.

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Awarded 0.75 contact hour(s) of continuing nursing education for RNs and APNs; none of these credits is in the area of pharmacology.

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For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact [email protected]

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There are no fees for participating in or receiving credit for this online educational activity. For information on applicability and acceptance of continuing education credit for this activity, please consult your professional licensing board.

This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity online during the valid credit period that is noted on the title page. To receive AMA PRA Category 1 Credit™, you must receive a minimum score of 70% on the post-test.

Follow these steps to earn CME/CE credit*:

Read the target audience, learning objectives, and author disclosures.
Study the educational content online or printed out.
Online, choose the best answer to each test question. To receive a certificate, you must receive a passing score as designated at the top of the test. Medscape Education encourages you to complete the Activity Evaluation to provide feedback for future programming.

You may now view or print the certificate from your CME/CE Tracker. You may print the certificate but you cannot alter it. Credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print out the tally as well as the certificates by accessing "Edit Your Profile" at the top of your Medscape homepage.

*The credit that you receive is based on your user profile.

From FDA and Medscape Education

CME/CE

Transforming a Clinician Into an Investigator: What Does It Take?

Authors: Leonard Sacks, MD; Robert L. Coleman, MD; Kenneth Getz, MBA; Frederick P. Ognibene, MDFaculty and Disclosures

THIS ACTIVITY HAS EXPIRED FOR CREDIT

CME/CE Released: 11/15/2011

Valid for credit through: 11/15/2012, 11:59 PM EST

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Editor's Note:
Clinical trials are essential to the development of evidence-based medicine, and the role of clinical investigator represents a unique opportunity to participate in this vital process. Medscape Education has developed this CME/CE activity to help clarify the responsibilities of clinical investigators and to address some of the challenges that investigators face today. Experts from the US Food and Drug Administration (FDA), the National Institutes of Health, MD Anderson Cancer Center, and CenterWatch participated in this panel discussion, which was taped on September 20, 2011, at the FDA headquarters. The panel discussion was moderated by Dr. Leonard Sacks, Acting Director of the Office of Critical Path Programs at the FDA. Medscape Education is pleased to partner with these experts to bring this important program to its members.

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Disclaimer

The material presented here does not necessarily reflect the views of Medscape, LLC, or companies that support educational programming on www.medscape.org. These materials may discuss therapeutic products that have not been approved by the US Food and Drug Administration and off-label uses of approved products. A qualified healthcare professional should be consulted before using any therapeutic product discussed. Readers should verify all information and data before treating patients or employing any therapies described in this educational activity.

Faculty and Disclosures

Authors

Leonard Sacks, MD

Robert L. Coleman, MD

Kenneth Getz, MBA

Frederick P. Ognibene, MD

Editor

Sarah Williams, PhD

CME Reviewer

Nafeez Zawahir, MD

Nurse Planner

Laurie E. Scudder, DNP, NP

CME/CE

Transforming a Clinician Into an Investigator: What Does It Take?

Target Audience and Goal Statement

Disclosures

Authors

Leonard Sacks, MD

Robert L. Coleman, MD

Kenneth Getz, MBA

Frederick P. Ognibene, MD

Editor

Sarah Williams, PhD

CME Reviewer

Nafeez Zawahir, MD

Nurse Planner

Laurie E. Scudder, DNP, NP

Accreditation Statements

For Physicians

For Nurses

Instructions for Participation and Credit

Transforming a Clinician Into an Investigator: What Does It Take?