Navigating Clinical Trials: Essential Knowledge for Dermatologists
Date of Original Release: December 16, 2024
Date of Expiration: December 16, 2027
Estimated Time of Completion: 7 Hours
Target Audience
Dermatologists and others involved in the delivery of dermatologic care.
Statement of Need
The American Academy of Dermatology bases its CME activities on identified professional practice gaps, the educational needs which underlie these gaps, and emerging clinical research findings as these relate to dermatology. Learners should reflect upon clinical and scientific information presented in this CME activity and determine the need for further study.
Learning Objectives
Following participation in this activity, the learner should be able to:
- Discuss the basic structure and set up of a clinical trial unit in both academic centers and community.
- Utilize the practical tips to start an investigator initiative study.
- Review the important factors in the studies selection, contracts and budget negotiation, FDA audit
Accreditation Statement
The American Academy of Dermatology is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
AMA PRA Credit Statement
The American Academy of Dermatology designates this enduring material for a maximum of 7 AMA PRA Category 1 CreditTM. Physicians should only claim the credit commensurate with the extent of their participation in the activity.
Instructions to Claim Credit
To Claim CME credit for this activity, the learner must complete the post-activity evaluation survey.
Planner & Reviewer
Afsaneh Alavi, MD, FAAD
Professor
Mayo Clinic
Rochester, Minnesota
Faculty
Alexandra Kimball, MD, MPH, FAAD
Professor
Harvard Medical School
Beth Israel Deaconess Hospital
Boston, Massachusetts
Amy Paller, MD, FAAD
Professor and Chair
Northwestern University – Feinberg School of Medicine
Chicago, Illinois
April Armstrong, MD, MPH, FAAD
Professor and Chief
Northwestern University – Feinberg School of Medicine
Chicago, IL
Chih-Ho Hong, MD
SkinfitMD
Surrey, British Columbia
David Rosmarin, MD, FAAD
Chair
Indiana University School of Medicine
Indianapolis, Indiana
Edward Lain, MD, FAAD
Sanova Dermatology
Austin, Texas
Emma Guttman, MD, PhD, FAAD
Professor and Chair
Icahn School of Medicine at Mount Sinai
New York, New York
Iltefat Hamzavi, MD, FAAD
Physician
Henry Ford Hospital
Canton, Michigan
James Del Rosso, DO, FAAD
Adjunct Professor
Touro University Nevada
Henderson, Nevada
John Harris, MD, PhD, FAAD
Professor and Chair
University of Massachusetts – Chan Medical School
Worcester, Massachusetts
Linda Stein Gold, MD, FAAD
Director
Henry Ford Hospital
Detroit, Michigan
Mark Lebwohl, MD, FAAD
Professor and Dean
Icahn School of Medicine at Mount Sinai
New York, New York
Melinda Gooderham, MD, FAAD
Assistant Professor
Queen’s University
Peterborough, Ontario
Neal Bhatia, MD, FAAD
Director
Therapeutics Clinical Research
San Diego, California
Robert Bissonnette, MD, MSc, FAAD
Chief Executive Officer
Innovaderm Research Inc.
Montreal, Quebec
Saakshi Khattri, MD, MBBS, FAAD
Associate Professor
Icahn School of Medicine at Mount Sinai
New York, New York
Seth Forman, MD
FCR-CenExel
Tampa, Florida
Susan Taylor, MD, FAAD
Bernett L. Johnson Endowed Professor
Perelman School of Medicine
Philadelphia, Pennsylvania
Todd Schlesinger, MD, FAAD
Assistant Professor
The George Washington University School of Medicine
Charleston, South Carolina
Staff
Christine Presta
Director, Digital Learning
Rosemont, Illinois
Janet Chester
Manager, Learning Resources
Rosemont, Illinois
Emma Hostetler
Coordinator, Learning Resources
Rosemont, Illinois
Dustin Herlich
Manager, Digital Learning
Rosemont, Illinois
Melinda Keske
Senior Coordinator, Digital Learning
Rosemont, Illinois
Camilia Schawel
Instructional Designer, Digital Learning
Rosemont, IL
Donna L. Roberts-Luttrell, CPT
Instructional Designer, Digital Learning
Rosemont, IL
Disclosures
All planners, speakers, reviewers, and staff for this activity have no relevant financial relationships with ineligible companies (formerly known as commercial interests).
Conflict Mitigation Statement
In accordance with the ACCME Standards for Integrity and Independence in Accredited Continuing Education, the American Academy of Dermatology has implemented mechanisms, prior to the planning implementation of this activity, to identify and mitigate conflicts of interest for all individuals in a position to control the content.
Unapproved Use Disclosure
The American Academy of Dermatology requires CME faculty/authors to disclose to learners when products or procedures are being discussed are off-label (not approved for the indications being discussed), unlabeled (not approved for any indications), experimental and/or investigational (not FDA approved); and any limitations on the information that is presented, such as data that are preliminary or that represent ongoing research, interim analyses, and/or unsupported opinion. This information is intended solely for continuing medical education and is not intended to promote off-label use of these products/procedures. If you have questions, contact the medical affairs department of the manufacturer for the most recent approval information. Faculty/authors of this activity may be discussing information about pharmaceutical agents that is outside of the U.S. Food and Drug Administration approved labeling.
Disclaimer
The American Academy of Dermatology (AAD) is not responsible for statements made by the author(s). Statement or opinions expressed in this activity reflect the views of the author(s) and do not reflect the official policy of the AAD. The information provided in this CME activity is for continuing education purposes only, is not intended to establish a standard of care, and is not meant to substitute for independent medical judgment of a health provider relative to the diagnostic, management and treatment options of a specific patient’s medical condition.
No Medical Advice
The information in this publication by the American Academy of Dermatology or any third party should not be considered medical advice and is not intended to replace consultation with a qualified dermatology professional. The American Academy of Dermatology does not answer specific medical questions or refer people to a particular dermatology professional.
Contact Information
For the American Academy of Dermatology Member Resource Center, please call (866) 503-7546.