Activity Outline
FDA’s Clinical Investigator Training Course
November 4 - 6, 2014
Holiday Inn, 10000 Baltimore Ave, College Park, Maryland 20740
Description
FDA's Clinical Investigator Training Course is designed for physicians, nurses, pharmacists and other healthcare professionals
involved in clinical trials. Lectures presented by senior FDA experts as well as guest lecturers from industry and academia explore the
scientific, regulatory and ethical aspects of clinical trials. They also include discussions of non-clinical, early clinical, and phase 3
studies, issues in the design and analysis of trials, safety and ethical considerations and FDA regulatory requirements related to the
performance and evaluation of clinical studies.
References
1.
Title 21, Chapter I, Subchapter A, parts 50 (protection of human subjects), 54 (financial disclosure by clinical investigators),
and 56 (IRBs)
2.
Title 21, Chapter I, Subchapter D, parts 300-499 (drugs for human use)
3.
Title 21, Chapter I, Subchapter F, parts 600-680 (biologics)
4.
Title 21, Chapter I, Subchapter H, parts 800-898 (medical devices)
Learning Objectives After completion of this activity, the participant will be able to:
1.
2.
3.
4.
Explain the responsibilities of an investigator conducting a clinical trial
Describe what to look for in drugs being studied in a clinical trial
Describe the basic concepts of clinical trial design
Review clinical data for sources of bias and errors
Target Audience
This activity is intended for physicians, pharmacists, nurses and others who are responsible for the conduct of clinical trials.
Schedule
Agenda
Tuesday, November 4
8:20 am – 12:00 pm
ACPE Universal Activity Number 0601-0000-14-087-L04-P
2.75 contact hours
1:00 pm – 5:15 pm
ACPE Universal Activity Number 0601-0000-14-088-L04-P
4 contact hours
7:30 am– 8:20am
Registration and Distribution of Course Material
Session 1: The Clinical Trial Protocol
8:20am – 8:30am
Welcome/Introduction
Leonard Sacks, M.D. (CDER)
8:30am – 9:00am
FDA Structure and Mandate
Leonard Sacks, M.D. (CDER)
9:00am – 10:00am
The Design of Clinical Trials (Part 1)
Robert Temple, M.D. (CDER)
10:00am – 10:15am
Break
10:15am – 10:45am
The Design of Clinical Trials (Part II)
Robert Temple, M.D. (CDER)
1
10:45am – 11:00am
Discussion/Questions
Robert Temple, M.D. (CDER)
11:00am – 11:30am
Clinical Trial Endpoints
Eugene Sullivan, M.D.
(EJS Consulting, LLC) - Not offered for CE
11:30am – 12:00pm
Issues in Clinical Trial Designs for Devices
Owen Faris, Ph.D. (CDRH)
12:00pm – 1:00pm
Lunch
1:00pm – 1:30pm
Issues in Clinical Trial Design for Companion Diagnostic
Devices
David Litwack, Ph.D. (CDRH)
1:30pm – 2:00pm
Issues in Clinical Trial Design for Rare Diseases
Anne Pariser, M.D. (CDER)
2:00pm – 2:45pm
Informed Consent and Ethical Considerations in Clinical
Trials
Dale Hammerschmidt, M.D.
(University of Minnesota)
Discussion/Questions
David Litwack Ph.D., Anne Pariser M.D. and
Dale Hammerschmidt M.D.
2:45 – 3:00pm
3:00pm – 3:15pm
Break
3:15pm – 3:45pm
Safety Considerations in Phase 1 Trials
3:45pm – 4:15pm
Safety Assessment in Clinical Trials and Beyond
Yuliya Yasinskaya, M.D. (CDER)
4:15pm – 4:45pm
Clinical Discussion of Special Populations
Ryan Owen, Ph.D. (CDER)
4:45pm – 5:15pm
Discussion/Questions
Sumathi Nambiar M.D., Yuliya Yasinskaya
M.D., and Ryan Owen Ph.D.
Sumathi Nambiar, M.D. (CDER)
Wednesday, November 5
8:30 am – 12:00 pm
ACPE Universal Activity Number 0601-0000-14-089-L04-P
3.25 contact hours
1:00 pm – 5:00 pm
ACPE Universal Activity Number 0601-0000-14-090-L04-P
3.75 contact hours
Session 2: FDA and the Regulation of Clinical Trials
8:30am – 9:00am
FDA Perspective on International Studies
Kassa Ayalew, M.D., M.P.H. (CDER)
9:00am – 9:45am
Good Clinical Practice (GCP) Key Topics
Bridget Foltz, M.S. (OC)
9:45am – 10:15am
Investigator Responsibilities – Regulation and Clinical Trials
(Part I)
Cynthia Kleppinger, M.D. (CDER)
10:15am – 10:30am
Break
2
10:30am – 11:00am
Investigator Responsibilities – Regulation and Clinical Trials
(Part 2)
Cynthia Kleppinger, M.D. (CDER)
11:00am – 11:45am
The Analysis of Investigator Data, Sources of Bias and Error
Susan Ellenberg, Ph.D.
(University of Pennsylvania)
11:45am – 12:00pm
Discussion and Questions
12:00pm – 1:00pm
Lunch
Bridget Foltz, M.S., Cynthia Kleppinger, M.D.,
Susan Ellenberg, Ph.D.
Session 3: Understanding the investigator brochure – Non-Clinical and Phase 1 Studies
1:00pm – 1:30pm
CMC and the investigator Brochure (Drugs): Ensuring the
Quality of a Drug used in a Clinical Trial
Dorota Matecka, Ph.D. (CDER)
1:30pm – 2:00pm
Biosimilar Biological Products
Sue Lim, M.D. (CDER)
2:00pm – 2:45pm
Pharmacology/Toxicology in the Investigator Brochure
Brenda Gehrke, Ph.D. (CDER)
2:45pm – 3:00pm
Discussion/Questions
Dorota Matecka, Ph.D., Sue Lim, M.D.,
Brenda Gehrke, Ph.D.
3:00pm – 3:15pm
Break
Session 4: Early Clinical Studies Session
3:15pm – 3:45pm
Clinical pharmacology 1: Phase 1 studies and Early Drug
development
Shirley Seo, Ph.D. (CDER)
3:45pm – 4:15pm
Clinical pharmacology 2: Clinical Considerations During
Phase 2 and Phase 3 of Drug Development
Kellie Reynolds, Pharm.D. (CDER)
4:15pm – 4:45pm
Electronic Technologies in Clinical Trials
Leonard Sacks, M.D. (CDER)
Patrick McNeilly, Ph.D. (OC)
4:45pm – 5:00pm
Discussion/Questions
Shirley Seo, Ph.D., Kellie Reynolds, Pharm.D.,
Leonard Sacks, M.D., Patrick McNeilly, Ph.D.
(OC)
3
Thursday, November 6
8:30 am – 11:45 am
ACPE Universal Activity Number 0601-0000-14-091-L04-P
3 contact hours
12:45 – 3:30 pm
ACPE Universal Activity Number 0601-0000-14-092-L04-P
1.75 contact hours
Session 5: Putting It All Together – Application and Compliance Issues
Concurrent Breakout Sessions for Drug/Device/Biologics – same topics offered simultaneously specific to each product
type
Center for Drug Evaluation and Research
Session 1
How to put together an IND submission
Judit Milstein, B.Sc.(CDER)
8:30am – 10:00am
Clinical Investigator Site Inspections-What to
Constance Cullity, M.D. (CDER
Expect
Session 1
8:30am – 10:00am
Center for Biologics Evaluation and Research
How to put together an Application
Session 1
8:30am – 10:00am
Center for Devices and Radiological Health
How to put together an Application
10:00am - 10:15am
Break
Center for Drug Evaluation and Research
Ensuring the Safety of Clinical Trials: AE
Reporting, DSMBs, IRBs
Center for Biologics Evaluation and Research
Ensuring the Safety of Clinical Trials: AE
Reporting, DSMBs, IRBs
Session 2
10:15am -11:15am
Session 2
10:15am -11:15am
Donald Fink, Ph.D. (CBER)
Allen K. Wensky, Ph.D. (CBER)
Rachel Witten, M.D. (CBER)
Lynn Henley, M.S. (CDRH)
Irfan Khan, M.S. (CDRH)
Session 2
10:15am -11:15am
Center for Devices and Radiological Health
Device Post Approval and Registry Studies
Session 3
11:15am – 11:45am
Center for Drug Evaluation and Research
Discussion/Questions
Session 3
11:15am – 11:45am
Center for Biologics Evaluation and Research
Discussion/Questions
Session 3
11:15am – 11:45am
Center for Devices and Radiological Health
Discussion/Questions
11:45am – 12:45pm
Lunch
Mathew Thomas, M.B., B.S. (CDER)
Patricia Holobaugh, M.S. (CBER)
Nilsa Loyo-Berrios, Pharm.D. (CDRH)
Daniel A Canos, Ph.D. (CDRH)
Benjamin Eloff, Ph.D.(CDRH)
Judit Milstein, BSc (CDER)
Constance Cullity, M.D. (CDER)
Mathew Thomas, M.B., B.S. (CDER)
Donald Fink, Ph.D. (CBER)
Allen K Wensky, Ph.D. (CBER)
Rachel Witten, M.D. (CBER)
Patricia Holobaugh, M.S. (CBER)
Lynn Henley, M.S. (CDRH)
Irfan Khan, M.S. (CDRH)
Nilsa Loyo-Berrios, Pharm.D. (CDRH)
Daniel A Canos, Ph.D., (CDRH)
Benjamin Eloff, Ph.D.(CDRH)
Session 6: Safety of Clinical Trials and Special Populations
12:45pm – 1:15pm
1:15pm – 1:45pm
1:45pm-2:15pm
2:15pm-3:15pm
3:15pm – 3:30pm
Special Cardiac Safety Concerns
Drug-Induced Liver Injury (DILI)
A Patient Advocate’s Perspective on Clinical
Trials
Roundtable : The Clinical Investigator’s Role in
Drug Development: a multi stakeholder
perspective
Explain Evaluation Process, Wrap up and
Adjourn
Shari Targum, M.D. (CDER)
Lana Pauls, M.P.H. (CDER)
Jane Reese-Coulbourne, M.S. ChE
Reagan-Udall Foundation
Federico Asch, M.D., Medstar
Diana Foster, Ph.D., SCRS
Sabrina Savic-Comic, M.D., MPH, The Medicine
Company
Not offered for CE
Leonard Sacks, M.D. (CDER)
4
Continuing Education
The Food and Drug Administration, Center for Drug Evaluation and Research is accredited by the Accreditation Council for
Continuing Medical Education to provide continuing medical education for physicians.
The Food and Drug Administration – Center for Drug Evaluation and Research designates this live activity for a maximum of 18.5
AMA PRA Category 1 Credit(s)TM. Physicians should claim only the credit commensurate with the extent of their participation in the
activity.
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation
Council for Continuing Medical Education (ACCME) through the joint providership of the Food and Drug Administration, Center for
Drug Evaluation and Research and Duke University. The Food and Drug Administration, Center for Drug Evaluation and Research is
accredited by the ACCME to provide continuing medical education for physicians.
The FDA-Center for Drug Evaluation and Research is accredited by the Accreditation Council for Pharmacy Education as a Provider
of continuing pharmacy education. Please reference the ACPE Universal Activity Numbers above. Each UAN indicates the number
of contact hours for that session. A maximum of 18.5 contact hours will be awarded to those participants who successfully complete
all sessions and meet the requirements for CE.
This activity is a Knowledge- based activity. These CE activities are primarily constructed to transmit knowledge (i.e., facts). The
facts must be based on evidence as accepted in the literature by the health care professions.
FDA, Center for Drug Evaluation and Research is an approved provider of continuing nursing education by the Maryland Nurses
Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation.
This 18.5 contact hour Education Activity is provided by FDA, Center for Drug Evaluation and Research. Each nurse should claim
only the time that he/she actually spent in the educational activity.
Requirements for receiving CE credit
Physicians, pharmacists, nurses and those claiming non-physician CME: attendance is verified by a sign-in sheet and completion of
the final activity evaluation. Final activity evaluations must be completed within two weeks after the activity. Pharmacy participants
will need their NABP e-profile ID number as well as their DOB in MMDD format in order to claim CE credit.
Statements of Credit
Physicians and Nurses Statements of Credit for CE will be issued 10 weeks after the last session of this activity. Pharmacists should
log into the CPE monitor 10 weeks after the last session of the activity to obtain their CE credit.
Disclosure
Faculty
Asch, Federico, M.D., Associate Director, Cardiovascular Core Labs, Medstar Research Health Institute, research grant paid from
company to employer/institution, Biotronik, GDS, Medtronic, St Jude Medical, NIH, for his role as an investigator
Ayalew, Kassa, M.D., M.P.H., Branch Chief, OMPT/CDER/OC/OSI/DGCPC/GCPAB, has nothing to disclose
Canos, Daniel A. Ph.D., MPH, Associate Director, CDRH/OSB/DEPI, nothing to disclose
Comic-Savic, Sabrina, M.D., MPH, Sr. Director, GCP Compliance, The Medicine Company, receives salary and stock as an employee
of The Medicine Company
Cullity, Constance, M.D., MPH, Supervisory Medical Officer/Good Clinical Practice Enforcement Branch Chief, FDA/CDER/Office
of Compliance/Office of Scientific Investigations/Division of GCP Compliance, has nothing to disclose
Ellenberg, Susan, Ph.D., Professor of Biostatistics, University of Pennsylvania, honoraria received from Otsuka Pharmaceuticals as a
data monitoring committee member; honorarium from Bristol Myers Squibb as a data monitoring committee member; honorarium
5
from Merck as a consultant and as a speaker at a statistical symposium; honorarium from Chelsea Pharmaceuticals as a consultant;
honorarium from Salix Pharmaceuticals as a consultant; honorarium GSK consulting; honorarium Janssen Pharmaceuticals statistical
lecture. Her spouse received an honorarium from Roche Pharmaceuticals as a data monitoring committee member and also received
honoraria from EnteroMedics and Vanda Pharmaceuticals as a consultant.
Eloff, Benjamin, MS, Ph.D., Senior Scientific Program Managerivision of Epidemiology, Office of Surveillance and Biometrics,
Center for Devices and Radiological Health, FDA, has nothing to disclose
Faris, Owen P, Ph.D., Clinical Trials Director (acting), FDA/CDRH, has nothing to disclose
Fink, Donald, Ph.D., Expert Biologist/Regulatory Review Scientist/CMC Specialist, FDA Center for Biologics Evaluation and
Research / Office of Cellular, Tissue and Gene Therapies, has nothing to disclose
Foltz, Bridget A, M.S., M.T. (ASCP), Health Scientist Policy Analyst, FDA/OC/OMPT/OSMP/OGCP, has nothing to disclose
Foster, Diana, Ph.D., Chief Safety Officer, Society for Clinical Research Sites (SCRS), has nothing to disclose
Gehrke, Brenda, Ph.D., Pharmacologist, Food and Drug Administration, has nothing to disclose
Hammerschmidt, Dale, M.D., Emeritus Professor of Medicine/University of Minnesota Medical School, has nothing to disclose
Henley, Lynn, M.S., M.B.A., Biologist, Investigational Device Exemption and Humanitarian Device Exemption Programs, Office of
Device Evaluation, Center for Devices and Radiological Health. In explaining the meaning of significant and non-significant risk
device studies, I will be providing examples of off-label uses of FDA approved products in demonstrating the need for a sponsor to
submit an IDE.
Holobaugh, Patricia, M.S., B.S., Branch Chief / Supervisory Consumer Safety Officer, FDA/CBER/Office of Compliance and
Biologics Quality/Division of Inspections & Surveillance/Bioresearch Monitoring Branch, has nothing to disclose
Khan, Irfan, M.S., Operations and Outreach Lead, CDRH/OC/DBM, has nothing to disclose
Kleppinger, Cynthia, M.D., Senior Medical Officer, Good Clinical Practice Assessment Branch, Division of Good Clinical Practice
Compliance, Office of Scientific Investigations, Office of Compliance, CDER/FDA, has nothing to disclose
Lim, Sue, B.S., M.S., M.D., Senior Staff Fellow, FDA/CDER/OND/IO/Therapeutic Biologics and Biosimilars Team, has nothing to
disclose
Litwack, David, Ph.D., Staff Fellow, FDA/CDRH/OIR/Personalized Medicine Staff, has nothing to disclose
Loyo-Berrios, Nilsa, Ph.D., MSc, Associate Director, Division of Epidemiology, Office of Surveillance and Biometrics, CDRH
Epidemiology, OMPT/CDRH/OSB/DEPI, has nothing to disclose
Matecka, Dorota M, Ph.D., Chemistry, Manufacturing and Controls (CMC) Lead, ONDQA/OPS/CDER/FDA, has nothing to disclose
McNeilly, Patrick J., Ph.D., C.I.P., Captain, USPHS, Office of Good Clinical Practice, FDA, has nothing to disclose
Milstein, Judit, B.Sc., Chief, Project Management Staff, FDA/CDER/OND/OIP/DTOP, has nothing to disclose
Nambiar, Sumathi, M.D., MPH, Acting Director, FDA/CDER/OND/DAIP, has nothing to disclose
Owen, Ryan, Ph.D., Clinical Pharmacologist, FDA/CDER/OTS/OCP/DCP4, has nothing to disclose
Pariser, Anne, M.D., Associate Director, Office of Translational Sciences, Office of New Drugs, Center for Drug Evaluation and
Research, FDA, has nothing to disclose
Pauls, Lana, M.P.H., Associate Director, Executive Operations and Strategic Planning, Office of Surveillance and Epidemiology
CDER/FDA, has nothing to disclose
Reese-Coulborne, Jane, M.S. ChE, B.S. Chemistry, Executive Director, Reagan-Udall Foundation for the FDA, has nothing to
disclose
6
Reynolds, Kellie S, Pharm.D., Deputy Division Director, OTS/OCP/DCPIV, has nothing to disclose
Sacks, Leonard, M.D., Acting Deputy Director, OMP/CDER, has nothing to disclose
Seo, Shirley, Ph.D., Clinical Pharmacology Team Leader, OCP/OTS/CDER/FDA, has nothing to disclose
Sullivan, Eugene (Gene), M.D., FCCP, Principal, EJS Consulting, LLC – discloses Salary Astra Zeneca, consulting fees from several
pharmaceutical firms for his role as a consultant- confidential
Targum, Shari, M.D., Clinical Team Leader, Division of Cardiovascular and Renal Products, CDER/FDA, has nothing to disclose
Temple, Robert, M.D., Deputy Center Director for Clinical Science, FDA/CDER, has nothing to disclose
Thomas, Mathew T, M.B., B.S., Director (Acting), Division of Safety Compliance, FDA/CDER/Office of Compliance/Office of
Scientific Investigations, has nothing to disclose
Wensky, Allen K, Ph.D., Biologist, FDA/CBER/Office of Cellular, Tissue, and Gene Therapies, has nothing to disclose
Witten, Rachael, M.D., Clinical Reviewer, FDA/CBER, has nothing to disclose
Yasinskaya, Yuliya, M.D., Medical Officer, FDA/CDER/OND/OAP/DAIP, has nothing to disclose
Planning Committee, CASE and FDA CE Team Reviewers
Chang, Ching-Jey George, D.V.M., M.S., Ph.D., Senior Pharmacologist, FDA/CDER/OND/OHOP/DHOT, has nothing to disclose
Chhina, Mantej Ph.D., Staff Fellow/Health Science Policy Analyst, FDA/OMPT/CDER/OMP/OMPI/DMPD, has nothing to disclose
Giroux, Virginia, M.S.N, FNP-BC, CE Program Administrator, FDA/CDER/OEP/DLOD, has nothing to disclose
Hinton, Denise, R.N., Acting Director for the Office of Medical Policy, FDA/CDER, has nothing to disclose
Kirchoff, Matthew, Pharm.D., Regulatory Program Manager, IO /OMP/CDER/FDA, has nothing to disclose
Lam, See Yan, Pharm. D., Ph.D., Regulatory Health Education Specialist, FDA/CDER/OEP/DLOD, has nothing to disclose
Rouse, Rodney, D.V.M., M.B.A., Ph.D., Research Veterinary Medical Officer, CDER, OTS, OCP, DARS, has nothing to disclose
Sacks, Leonard, M.D., Acting Deputy Director, OMP/CDER, nothing to disclose
Shahidzadeh, Rokhsareh, M.S.N., R.N. Regulatory Education Specialist, FDA/CDER/OEP/DLOD, has nothing to disclose
Tiernan, Rosemary (Rose), M.D., M.P.H., Medical Officer, Office of Medical Policy Initiatives (OMPI)/Center for Drug Evaluation
and Research /FDA, has nothing to disclose
Tran, Quynh-Van, Pharm.D., Regulatory Review Officer, FDA/CDER/OMP/Office of Prescription Drug Promotion, nothing to
disclose
Zawalick, Karen, Lead Education Program Specialist, FDA/CDER/OEP/DLOD, has nothing to disclose.
Registration Fees and Refunds
Registration is complimentary therefore refunds are not applicable.
Requirements for Certificate of Completion (Non CE)
Must attend 80% of the lectures (verified by a sign-in sheet).
Initial Release Date: November 4, 2014
7