Not All Clinical Trials Are Created Equal – Understanding the Different Phases
Target Audience
This activity has been designed to meet the educational needs of physicians and other healthcare providers who are interested in participating in clinical trial research.
Educational Objectives
After completing this activity, the participant should be better able to:
Outline the drug development process from preclinical investigations through clinical testing
Describe the purpose and design of Phase 1–4 clinical studies
Explain the characteristics of each type of clinical trial (ie, treatment, diagnostic, etc)
Faculty
Cynthia Guzzo, M.D., Centocor Ortho Biotech Inc.
Physician Continuing Medical Education
Accreditation Statement
This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Postgraduate Institute for Medicine (PIM), BioCentric, Inc., and International Psoriasis Council (IPC). PIM is accredited by the ACCME to provide continuing medical education for physicians.
Credit Designation
Postgraduate Institute for Medicine designates this educational activity for a maximum of 0.5 AMA PRA Category 1 Credit(s)™. Physicians should only claim credit commensurate with the extent of their participation in the activity.
Disclosure of Conflicts of Interest
Postgraduate Institute for Medicine (PIM) assesses conflict of interest with its instructors, planners, managers and other individuals who are in a position to control the content of CME activities. All relevant conflicts of interest that are identified are thoroughly vetted by PIM for fair balance, scientific objectivity of studies utilized in this activity, and patient care recommendations. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.
The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME activity:
Cynthia Guzzo, M.D.
Salary: Centocor, J&J
Ownership Interest (stocks, stock options or other ownership interest excluding diversified mutual funds): Centocor, J&J
The editors reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME activity.
Craig Leonardi, M.D.
Consulting Fees (e.g., advisory boards): Abbott, Amgen, Centocor, Genentech
Fees for Non-CME Services Received Directly from a Commercial Interest or their Agents (e.g., speakers' bureaus): Abbott, Amgen, Centocor, Genentech
Contracted Research: Abbott, Altana, Alza, Amgen, Celgene, Centocor, Genentech, Eli Lilly, Galderma, Genzyme, Novo Nordisk, Pfizer, Incyte, Perrigo Israel Pharmaceutical, Novartis, Vitae, and Wyeth
Kim Papp, M.D.
Has no real or apparent conflicts of interest to report.
The planners and managers reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME activity:
The following PIM planners and managers, Linda Graham, RN, BSN, BA, Jan Hixon, RN, BSN, MA, Trace Hutchison, PharmD, Julia Kirkwood, RN, BSN and Jan Schultz, RN, MSN, CCMEP hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.
Liz Horn, Ph.D., International Psoriasis Council, and Meredith Rogers, M.S. and Adam Valerio, B.S., BioCentric, Inc., hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.
Media: Internet
Method of Participation
There are no fees for participating and receiving CME credit for this activity. During the period June 1, 2009 through May 31, 2011, participants must 1) read the learning objectives and faculty disclosures; 2) study the educational activity; 3) Complete the post-test online at: www.cmeuniversity.com. On the navigation menu, click on “Find Post-tests by Course” and search by project ID 4962. Upon registering and successfully completing the post-test with a score of 70% or better and the evaluation, your certificate will be made available immediately.
Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The Postgraduate Institute for Medicine (PIM), BioCentric, Inc., and International Psoriasis Council (IPC) do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of PIM, Biocentric, Inc., or IPC. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Disclaimer
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.