Target Audience
This activity is intended for physicians, pharmacists, nurses, researchers and others who are responsible for the conduct of clinical trials.
Additional Training
Looking for more training? The University of Maryland online MS in regulatory science degree program provides graduates with the knowledge and skills necessary to contribute to drug and biologics regulation and pharmaceutical product lifecycles. Designed for working professionals, the degree program is exclusively online and is part-time over two years. More information is available online.
Below are slides from the Clinical Investigator Training Course held on November 13-15, 2018, in Silver Spring, Maryland.
To be alerted when registration for the 2019 course opens, please email clinicalinvestigator@fda.hhs.
Session 1: Trial Design |
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FDA Structure and Mandate |
Leonard Sacks, M.D. |
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The Design of Clinical Trials |
Robert Temple, M.D. |
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Clinical Trial Endpoints |
Elektra Papadopoulos, M.D. FDA, CDER |
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Electronic Technologies in Clinical Trials and clinicaltrials.gov |
Leonard Sacks, M.D. |
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Discussion & Questions |
Bridget Foltz, M.S. |
Recording |
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Issues in Clinical Trial Designs for Devices |
Soma Kalb, Ph.D. |
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Issues in Clinical Trial Design for Companion Diagnostic Devices |
Karen Bijwaard, M.S., RAC, MB(ASCP), CQA |
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Issues in Clinical Trial Design for Rare Diseases |
Patroula Smpokou, M.D., FACMG
FDA, CDER
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Discussion & Questions |
Soma Kalb, Ph.D. |
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Session 2: Ethics and Human Subject Protection |
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Informed Consent and Ethical Considerations in Clinical Trials |
Jon Mark Hirshon M.D., Ph.D., M.P.H.
University of Maryland
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Good Clinical Practice (GCP) Key Topics |
Bridget Foltz, M.S.
FDA, OC
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Discussion & Questions |
Jon Mark Hirshon M.D.,
Bridget Foltz, M.S.
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Session 3: Trial Populations and Safety |
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FDA Perspective on International Studies |
Kassa Ayalew, M.D., M.P.H.
FDA, CDER
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Clinical Discussion of Specific Populations |
Su-Young Choi, Pharm.D., Ph.D.
FDA, CDER
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Safety Considerations in Phase I Trials |
Joseph G. Toerner, M.D, M.P.H.
FDA, CDER
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Safety Assessment in Clinical Trials and Beyond |
Yuliya Yasinskaya, M.D.
FDA, CDER
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Discussion & Questions |
Kassa Ayalew, M.D., M.P.H.
Su-Young Choi, Pharm.D., Ph.D.
Joseph G. Toerner, M.D, M.P.H.
Yuliya Yasinskaya, M.D.
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Recording |
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Investigator Responsibilities — Regulation and Clinical Trials |
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Recording | Slides |
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Session 5: Statistical Considerations
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The Analysis of Investigator Data, Sources of Bias and Error |
Susan Ellenberg, Ph.D.
University of Pennsylvania
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Session 6: Understanding the Investigator Brochure: Non-Clinical and Early Clinical Studies
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CMC and the Investigator Brochure: Ensuring the Quality of a Drug is used in a Clinical Trial |
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Pharmacology/Toxicology in the Investigator Brochure |
Brenda Gehrke, Ph.D.
FDA, CDER
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Discussion & Questions |
Brenda Gehrke, Ph.D.
Erika Englund, Ph.D.
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Clinical Pharmacology |
Shirley Seo, M.D.
FDA, CDER
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Biosimilar Biological Products |
Sue Lim, M.D.
FDA, CDER
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Discussion and Questions |
Shirley Seo, M.D.
Sue Lim, M.D.
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Session 7: INDs and IDEs from Start to Finish |
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Center for Drug Evaluation and Research: How to Put together an IND Submission |
Judit Milstein, D.Sc.
FDA, CDER
Eithu Z. Lwin, Pharm.D.
FDA, CDER
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Center for Biologics Evaluation and Research: Putting Together Your IND Application (CBER): CMC, Preclinical Testing and Clinical Trial Design Expectations to Ensure Safety for a First-in-Human Clinical Investigation |
Donald Fink, Ph.D.
FDA, CBER
Allen K. Wensky, Ph.D.
FDA, CBER
Rachel Witten, M.D., FAAP
FDA, CBER
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Center for Devices and Radiological Health: How to Put together an IDE Submission: Safety and Effectiveness |
Joshua Chetta, Ph.D.
FDA, CDRH
Jiping Chen, M.D., Ph.D., M.P.H.
FDA, CDRH
Nadezda Radoja, Ph.D.
FDA, CDRH
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Clinical Investigator Site Inspections- What to Expect |
Michelle Anantha, MSPAS, PA-C, RAC
FDA, CDER
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Session 8: Patient Perspective |
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Patient Perspective/Engagement in Drug Development |
Pat Furlong
Founding President & CEO
Parent Project Muscular Dystrophy
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Discussion and Questions |
Michelle Anantha, MSPAS, PA-C, RAC
Pat Furlong
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Session 9: Safety and Efficacy — Special Topics |
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Phase I Development Oncology- Investigator’s Perspective |
Edward Sausville, M.D., Ph.D., F.A.C.P
University of Maryland
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Hepatotoxicity |
Mark Avigan, M.D., CM
FDA, CDER
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Recording | Slides |
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Special Cardiac Safety Concerns |
Shari Targum, M.D., M.P.H,
FDA, CDER
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| Human Genetics in Therapeutic Development and Clinical Trials |
Alan R. Shuldiner, M.D.
University of Maryland
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Recording |
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Process, Wrap-up and Adjourn |
Leonard Sacks M.D.
Edward Sausville, M.D., Ph.D., F.A.C.P.
Alan R. Shuldiner, M.D. Shari Targum, M.D., M.P.H.
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Recording |
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