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Activity Outline
Clinical Investigator Training Course (CITC)
December 7 - 8, 2022
Clinical Investigator Training Course (CITC)
December 7 - 8, 2022
Activity Coordinators:
Forest Ford (Forest.Ford@fda.hhs.gov), Brenda Stodart (Brenda.Stodart@fda.hhs.gov)
Description
This course is designed to promote professionalism in the clinical trial industry for individuals involved with submissions to FDA (Investigational New Drugs, New Drug Applications, Biologic Licenses Applications, and Investigational Device Exemptions) and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical products. Participants will acquire a practical understanding of FDA's approach to the evaluation of clinical trials, associated regulatory requirements, and other scientific issues related to investigational medical products.
References
- Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biologic Products Guidance for Industry – Draft Guidance https://www.fda.gov/regulatory-information/search-fda-guidance-documents/real-world-data-assessing-registries-support-regulatory-decision-making-drug-and-biological-products
- Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biologic Products – Draft Guidance https://www.fda.gov/regulatory-information/search-fda-guidance-documents/real-world-data-assessing-electronic-health-records-and-medical-claims-data-support-regulatory
- Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-real-world-data-and-real-world-evidence-support-regulatory-decision-making-drug
- Digital Health Technologies for Remote Data Acquisition in Clinical Investigations – Draft Guidance https://www.fda.gov/regulatory-information/search-fda-guidance-documents/digital-health-technologies-remote-data-acquisition-clinical-investigations
Learning Objectives
- Outline the most current design and conduct of clinical trials
- Explain the development of appropriate endpoints in clinical trials
- Propose a plan to demonstrate efforts to advance diversity in trial populations
- Choose appropriate statistical evaluation techniques for use in clinical trials
- Develop and recommend current innovative trial designs
- Identify the proper interpretation of the investigator brochure
- Appraise clinical trial quality
Target Audience
This activity is intended for physicians, pharmacists, and nurses.
This activity is intended for physicians, pharmacists, and nurses.
Agenda
Day 1 December 7, 2022
Day 2 December 8, 2022
Day 1 December 7, 2022
| Time | Topic | Speaker |
|---|---|---|
| 11:00 - 11:15 AM EST | SBIA Welcome and CE information | Brenda Stodart, PharmD, MS, BCGP, RAC |
| 11:15 - 11:30 AM EST | FDA Structure and Mandate | Leonard Sacks, MD |
| 11:30 - 12:00 PM EST | Endpoints in Cardiovascular Trials | Karen Hicks, MD |
| 12:00 - 12:30 PM EST | Special Populations in Clinical Trials | Lynne Yao, MD |
| 12:30 - 12:45 PM EST | Q&A Session |
Leonard Sacks, MD Karen Hicks, MD Lynne Yao, MD |
| 12:45 - 1:00 PM EST | Break | |
| 1:00 - 1:30 PM EST | Statistical Principles for Clinical Drug Development | Mark Levenson, PhD |
| 1:30 - 2:15 PM EST | Safety Considerations in Clinical Drug Development | Shabnam Naseer, DO |
| 2:15 - 2:30 PM EST | Q&A Session |
Leonard Sacks, MD Mark Levenson, PhD Shabnam Naseer, DO |
| 2:30 - 3:15 PM EST | Special Topics: Gene Therapy, CarT Therapy, International Clinical Trials |
Lei Xu, MD, PhD Lianne Hu, MD, PhD, MPH Kassa Ayalew, MD, MPH |
| 3:15 - 3:30 PM EST | Q&A Session |
Leonard Sacks, MD Lei Xu, MD, PhD Lianne Hu, MD, PhD, MPH Kassa Ayalew, MD, MPH |
| 3:30 - 3:35 PM EST | Day One Closing | Brenda Stodart, PharmD, MS, BCGP, RAC |
| Time | Topic | Speaker |
|---|---|---|
| 10:55 - 11:00 AM EST | Administrative Overview | Brenda Stodart, PharmD, MS, BCGP, RAC |
| 11:00 - 11:45 AM EST | Clinical Trial Quality | Winifred Meeker-OConnell, MS |
| 11:45 - 12:00 PM EST | Q&A Session |
Leonard Sacks, MD Winifred Meeker-OConnell, MS |
| 12:00 - 12:15 PM EST | Real World Evidence | John Concato, MD |
| 12:15 - 12:45 PM EST | Innovative Trial Designs (Decentralized Clinical Trials, Digital Health Technologies) | Leonard Sacks, MD |
| 12:45 - 1:00 PM EST | Q&A Session |
Leonard Sacks, MD John Concato, MD |
| 1:00 - 1:15 PM EST | Break | |
| 1:15 - 2:15 PM EST | Early Drug Development |
Paresma Patel, PhD Matthew Thompson, PhD, MPH Shirley Seo, PhD |
| 2:15 - 2:30 PM EST | Q&A Session |
Leonard Sacks, MD Paresma Patel, PhD Matthew Thompson, PhD, MPH Shirley Seo, PhD |
| 2:30 - 2:40 PM EST | Day Two Closing | Leonard Sacks, MD |
Continuing Education Accreditation
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
This activity was planned by and for the healthcare team, and learners will receive 7.75 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 7.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-22-083-L04-P for 7.75 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 7.75 contact hour(s).
Requirements for Receiving CE Credit
Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.
Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.
Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Disclosure
Faculty
Planning Committee
CE Consultation and Accreditation Team
Faculty
- Ayalew, Kassa, MD, MPH, Supervisory Medical Officer, FDA/CDER/OC/OSI - nothing to disclose
- Concato, John, MD, Supervisory Physician, CDER-OMP - nothing to disclose
- Hicks, Karen, MD, Deputy Director, Office of Medical Policy, FDA - nothing to disclose
- Hu, Lianne, MD, PhD, MPH, Clinical Analyst, FDA/CBER/OTAT/DCEPT - nothing to disclose
- Levenson, Mark, PhD, Division Director, FDA/CDER/OTS/OB/DBVII - nothing to disclose
- Meeker-OConnell, Winifred, MS, Director, Office of Clinical Policy, U.S Food and Drug Administration - I have the following relationship(s): Vertex Pharmaceuticals - Employee; Johnson & Johnson - Stock ; Merck & Co - Stock; Beckton Dickinson - Stock; Thermo Fisher Scientific - Stock; Eli Lilly & Co - Stock ; BioMarin Pharmaceuticals - Stock; Zoetis - Stock; Medtronic - Stock; Proctor & Gamble - Stock; Pfizer - Stock; Alcon Inc - Stock; Abbott Labs - Stock; Briston Myers Squibb - Stock ; Unilever - Stock; Target - Stock; Walmart - Stock; Amazon - Stock
- Naseer, Shabnam, DO, Acting Medical Team Leader, FDA - nothing to disclose
- Patel, Paresma, PhD, Division Director, Food and Drug Administration - nothing to disclose
- Sacks, Leonard, MD, Associate Director for Clinical Methodology, CDER/FDA - nothing to disclose
- Seo, Shirley, PhD, Director, Division of Cardiometabolic and Endocrine Pharmacology, Office of Clinical Pharmacology, OTS/CDER/FDA - nothing to disclose
- Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose
- Thompson, Matthew, PhD, MPH, Pharmacologist, FDA - nothing to disclose
- Xu, Lei, MD, PhD, Medical Officer, FDA - nothing to disclose
- Yao, Lynne, MD, Director, DPMH, CDER/OND/ODE4/DPMH - nothing to disclose
Planning Committee
- Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose
- Sacks, Leonard, MD, Associate Director for Clinical Methodology, CDER/FDA - nothing to disclose
- Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose
CE Consultation and Accreditation Team
- Faberlle, Alexandra M., Training Specialist / FDA/CDER/OEP/DLOD - nothing to disclose
- Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.
All relevant financial relationships have been mitigated.
Registration Information
Registration is complimentary; therefore refunds are not applicable.
Registration is complimentary; therefore refunds are not applicable.
Requirements for Certificate of Completion (Non CE)
Must attend 80% of the activity.
Must attend 80% of the activity.
U.S. Food and Drug Administration