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2025 Design and Management of Cancer Clinical Trials Course

  • Overview
  • Faculty
Add to Calendar 2025 Design and Management of Cancer Clinical Trials Course 9/5/2025 10:00:00 AM 10/10/2025 1:00:00 PM America/New_York For More Details: https://miami.cloud-cme.com/course/courseoverview?EID=18417 Description: This course is designed to provide physicians and others involved in developing and managing clinical trials with key information to advance a program of clinical research, foster better clinical trial design, and ultimately improve patient care. Over six weeks, participants will learn basic research concepts and principles that underlie the design and day-to-day conduct of cancer clinical trials. Cou... Online false MM/DD/YYYY


Date & Location
Friday, September 5, 2025, 10:00 AM - Friday, October 10, 2025, 1:00 PM, Online

Target Audience
Specialties - Breast Cancer, Cancer Survivorship, Cutaneous Oncology, Gastrointestinal Cancers, Gynecology-Oncology, Hematology, Medical Oncology, Neuro-Oncology, Oncology, Pediatric Oncology, Public Health Sciences, Radiation Oncology, Radiology, Sarcoma, Surgical Oncology
Professions - Allied Health Care Professional, Fellow, Hospitalist, Intensivist, Internist, Medical Student, Neuro-Oncologist, Non-Physician, Nurse, Nurse Practitioner, Other, Pathologist, Pathology Assistant, Patient Advocate, Pharmacist, Physician, Physician Assistant, Psychiatrist, Psychologist, Researcher, Resident, Scientist, Social Worker, Technologist

Credits
AMA PRA Category 1 Credits™ (18.00 hours), Non-Physician Attendance (18.00 hours)

Overview
This course is designed to provide physicians and others involved in developing and managing clinical trials with key information to advance a program of clinical research, foster better clinical trial design, and ultimately improve patient care. Over six weeks, participants will learn basic research concepts and principles that underlie the design and day-to-day conduct of cancer clinical trials. Course goals include the following: discuss the full spectrum of challenges and opportunities in clinical cancer research; facilitate collaborations and diverse networks among workshop participants; provide guidance on the development of clinical trial protocols; introduce principles of good trial design; and develop a cadre of well-trained, experienced clinical researchers who will become future leaders in clinically focused cancer research.

Objectives
At the conclusion of this activity, learners will be able to:

  1. Explain the concepts and rational for phase I, II, and III studies and describe aspects of design and methodology used in each type of study
  2. Describe the potential career paths of a clinical trialist
  3. Identify sources of support best suited to their research interests and career stage
  4. Understand the committee logistics involved in the protocol approval process
  5. Describe the roles and expected interactions of the various members of the clinical trial research team.
  6. Explain the pillars of valid consent, and how principles differ in clinical care and research

Accreditation
The University of Miami Leonard M. Miller School of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

 

The University of Miami Leonard M. Miller School of Medicine designates this Live Activity for a maximum of 18.00 of AMA PRA Category 1 CreditsTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

ACCME


Additional Information

Cancellation Policy

University of Miami Healthcare System reserves the right to cancel or postpone this program if necessary; in the event of cancellation, course fees will be fully refunded. We are not responsible for other costs incurred such as non-refundable airline tickets or hotel penalties.

Accessibility Statement
 
University of Miami Healthcare System is committed to ensuring that its programs, services, goods and facilities are accessible to individuals with disabilities as specified under Section 504 of the Rehabilitation Act of 1973 and the Americans with Disabilities Amendments Act of 2008.  If you have needs that require special accommodations, including dietary concerns, please contact the CME Conference Coordinator.




Keywords: LIVE



Mitigation of Relevant Financial Relationships


The University of Miami adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of a CE activity, including faculty, planners, reviewers or others are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity.

Member Information
Role in activity
Nature of Relationship(s) / Name of Ineligible Company(s)
Winsome Wilson, MA
Sylvester Comprehensive Cancer Center
Miami, FL
Activity Coordinator
Nothing to disclose
Vaughn Edelson, MPH, MPA
N/A
UM
Miami, FL
Co-Director
Nothing to disclose
Alan Pollack, MD, PhD
MD
UMMSM
Miami, FL
Course Director, Faculty
Nothing to disclose
Faculty Photos
Juan Pablo Alderuccio, MD
Associate Professor of Clinical Medicine
Sylvester Comprehensive Cancer Center
Miami, FL
Faculty
Esperanza Bas Infante, PharmD, PhD
Clinical Research Pharmacist
University of Miami
Miami, FL
Faculty
Nothing to disclose
Faculty Photos
Marijo Bilusic, MD, PhD
Professor of Clinical Medicine
Sylvester Comprehensive Cancer Center
Miami, FL
Faculty
Grant or research support-Surface Oncology (Relationship has ended)|Grant or research support-Merck |Grant or research support-Lilly (Any division) (Relationship has ended)|Grant or research support-Hookipa Pharma |Grant or research support-Marengo Therapeutics |Grant or research support-Bicycle Terapeutics
Lucia Carranza, APRN, AOCNP
Sylvester Comprehensive Cancer Center
Miami, FL
Faculty
Sarah Chadwell, MS, CGC
Sanofi
Cambridge, MA
Faculty
Employment-Sanofi S.A.
Faculty Photos
Aman Chauhan, MD
Associate Professor of Medical Oncology
Sylvester Comprehensive Cancer Center
Miami, FL
Faculty
Advisor-Ipsen Biopharmaceuticals, Inc. Ipsen Biopharmaceuticals, Inc.|Advisor-Crinetics|Advisor-Lexicon Pharmaceuticals, Inc.|Advisor-TerSera|Consulting Fee-Exelixis, Inc.|Consulting Fee-Curium|Consulting Fee-Seneca Therapeutics|Grant or research support-Bristol-Myers Squibb Company|Grant or research support-Clovis Oncology|Grant or research support-Seneca Therapeutics|Speakers Bureau-Crinetics
Codruta Chiuzan, PhD
PhD
Northwell Health
Miami, NY
Faculty
Nothing to disclose
Faculty Photos
Macarena De La Fuente, MD
University of Miami
Miami, FL
Faculty
Membership on Advisory Committees or Review Panels, Board Membership, etc.-Servier|Speakers Bureau-Medscape|Membership on Advisory Committees or Review Panels, Board Membership, etc.-Fore|Membership on Advisory Committees or Review Panels, Board Membership, etc.-AnHeart|Membership on Advisory Committees or Review Panels, Board Membership, etc.-Rigel
Charalampos S Floudas, MD, DMSc, MS
Associate Research Physician
Center for Cancer Research, National Cancer Institute, National Institutes of Health
Bethesda, MD
Faculty
Nothing to disclose
Sophia George, PhD
PhD
SYLVESTER COMPREHENSIVE CANCER CENTER, UNIVERSITY OF MIAMI
Miami, FL
Faculty
Grant or research support-Pfizer (Any division)|Grant or research support-GSK (Relationship has ended)
Leanne Hagen, MS
Genetic Counselor
Cincinnati Children's Hospital Medical Center
Cincinnati, OH
Faculty
Other: One time Advisory Committee-Amicus (Relationship has ended)
Chen Hu, PhD
Associate Professor
Johns Hopkins University School of Medicine
Baltimore, MD
Faculty
Consulting Fee-Johnson & Johnson|Consulting Fee-Belay Diagnostics
Farrah Jackson, MS, CCRP
Cincinnati Children’s Hospital Medical Center
Cincinnati, OH
Faculty
Nothing to disclose
Nicholas James, MBBS
Professor of Prostate and Bladder Cancer Research
The Institute of Cancer Research
London, United Kingdom
Faculty
Consulting Fee-AstraZeneca (Any division)|Grant or research support-AstraZeneca (Any division)|Consulting Fee-Astellas (Any division)|Grant or research support-Astellas (Any division)|Consulting Fee-Bayer (Any division)|Grant or research support-Novartis Corporation Pharmaceuticals|Advisor-Janssen (Any division)|Grant or research support-Janssen (Any division)|Grant or research support-Veracyte|Grant or research support-Artera
Gayle S. Jameson, MSN, ACNP-BC, AOCN
Nurse Practitioner, Associate Clinical Investigator
HonorHealth Research Instutute
SCOTTSDALE, AZ
Faculty
Nothing to disclose
Mi-Ok Kim, PhD
University of California San Francisco
San Francisco, CA
Faculty
Paid consultant-AER Inc.|Paid consultant-AdjuCor GmbH
Erin Kobetz, PhD, MPH
PhD, MPH
University of Miami Miller School of Medicine
South Miami, FL
Faculty
Nothing to disclose
Nina Lukinova, PhD
National Cancer Institute
Rockville, MD
Faculty
Nothing to disclose
Mitchell Machtay, MD
Faculty
Nicole S McCullough, MS, CCRP
Director, Regulatory Support
University of Miami
Miami, FL
Faculty
Nothing to disclose
Ruben Mesa, MD
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston Salem, NC
Faculty
Honoraria-Novartis Corporation Pharmaceuticals|Honoraria-Genentech (Any division)|Honoraria-BluePrint Genetics Inc.|Honoraria-Incyte Corporation Incyte Corporation|Honoraria-Bristol-Myers Squibb Company|Honoraria-AbbVie (Any division)
Faculty Photos
Craig H. Moskowitz, MD
Professor of Medicine
Sylvester Comprehensive Cancer Center
Miami, FL
Faculty
Aisha Mustapha, MBBS
MBBS
Zaria
Faculty
Laura Ochoa, BS
Clinical Research Coordinator
University of Miami
Miami, FL
Faculty
Nothing to disclose
Michael Paidas, MD
MD
UMMSM
Miami, FL
Faculty
Guillermo Perez, BA
Clinical Research Data Specialist
University of Miami
Miami, FL
Faculty
Nothing to disclose
Miguel Ramirez Menendez, RN
Faculty
Carolyn R Raski, MS, CGC
Genetic Counselor
Ann & Robert H. Lurie Children's Hospital
Chicago, IL
Faculty
Nothing to disclose
Faculty Photos
Estelamari Rodriguez, MD, MPH
Assistant Professor of Clinical Medicine
Sylvester Cancer Center
University of Miami, FL
Faculty
Roxana Sanchez Guerra, BA
Faculty
Hudson P Santos, Jr., RN, Ph.D., FABMR, FA
Jr., RN, Ph.D., FABMR, FA
Faculty
Matthew Schlumbrecht, MD
MD
University of Miami
Miami, FL
Faculty
Nothing to disclose
Mikkael Sekeres, MD, MS
MD, MS
University of Miami
Miami, FL
Faculty
Advisor-Bristol-Myers Squibb Company|Advisor-Kurome (Relationship has ended)|Advisor-AstraZeneca (Any division) (Relationship has ended)|Advisor-Agios (Relationship has ended)
Stephane Supiot, MD, PhD
Faculty
Mario Sznol, MD
MD
Yale University
New Haven, CT
Faculty
Stocks or stock options, excluding diversified mutual funds-Actym |Stocks or stock options, excluding diversified mutual funds-Adaptive Biotechnologies|Paid consultant-Asher|Paid consultant-Evolveimmune|Stocks or stock options, excluding diversified mutual funds-Glaxo|Stocks or stock options, excluding diversified mutual funds-Intensity|Stocks or stock options, excluding diversified mutual funds-Johnson & Johnson|Paid consultant-Nextcure|Paid consultant-Normunity|Paid consultant-Oncohost|Paid consultant-immunogenesis|Paid consultant-Regeneron|Paid consultant-Simcha|Paid consultant-Biond|Paid consultant-Cullinan|Consulting Fee-Bristol-Myers Squibb Company|Paid consultant-ideaya|Consulting Fee-dynamicure|Paid consultant-Biontech|Consulting Fee-Teva|Paid consultant-Innate|Consulting Fee-IO Biotech|Consulting Fee-Immatics|Consulting Fee-Pliant (Relationship has ended)|Consulting Fee-Incyte (Relationship has ended)|Consulting Fee-Verastem|Consulting Fee-GI innovation |Consulting Fee-Lyvgen (Relationship has ended)|Consulting Fee-Pfizer (Any division) (Relationship has ended)
Alyssa Vanderbeek, MS
Faculty
Kenia Viamonte, MA
Director, Buman Subject Research
University of Miami
Miami, FL
Faculty
Nothing to disclose
Louis Voigt, MD
Faculty
Alyssa Ward, BA, CCRP
Manager, Regulatory Support
University of Miami
Miami, FL
Faculty
Nothing to disclose
Faculty Photos
Diana Welch, MD
CME Manager
University of Miami
Miami, FL
Faculty
Honoraria-BluePrint Genetics Inc.

Friday, September 5, 2025
Phase I clinical trial design and statistics
10:00AM - 11:15AM
Codruta Chiuzan, PhD
Mario Sznol, MD

Phase II clinical trial design and statistics
11:15AM - 12:30PM
Mi-Ok Kim, PhD
Juan Pablo Alderuccio, MD

Panel: Bench-to-bedside translation
12:30PM - 1:00PM
Mario Sznol, MD
Michael Paidas, MD
Hudson P Santos, Jr., RN, Ph.D., FABMR, FA
Sophia George, PhD

Saturday, September 6, 2025
Sunday, September 7, 2025
Monday, September 8, 2025
Tuesday, September 9, 2025
Wednesday, September 10, 2025
Thursday, September 11, 2025
Friday, September 12, 2025
Phase III and non-interventional trial design and statistics
10:00AM - 11:15AM
Mitchell Machtay, MD
Chen Hu, PhD

Considerations in special trial design: The STAMPEDE trial
11:15AM - 12:00PM
Nicholas James, MBBS

Advancing Oncology Through Theranostics: Innovations in Targeted Drug Development
12:00PM - 1:00PM
Aman Chauhan, MD

Saturday, September 13, 2025
Sunday, September 14, 2025
Monday, September 15, 2025
Tuesday, September 16, 2025
Wednesday, September 17, 2025
Thursday, September 18, 2025
Friday, September 19, 2025
Roles and responsibilities of the study team
10:00AM - 11:00AM
Gayle S. Jameson, MSN, ACNP-BC, AOCN
Lucia Carranza, APRN, AOCNP
Alyssa Ward, BA, CCRP
Guillermo Perez, BA
Esperanza Bas Infante, PharmD, PhD
Laura Ochoa, BS

What it means to be a PI
10:00AM - 10:45AM
Marijo Bilusic, MD, PhD

Addressing catchment area populations in recruitment and retention
10:45AM - 11:30AM
Estelamari Rodriguez, MD, MPH

Regulatory management of clinical research
11:00AM - 12:00PM
Kenia Viamonte, MA
Nicole S McCullough, MS, CCRP

Crafting a successful LOI
11:30AM - 12:15PM
Macarena De La Fuente, MD

Talking to patients about clinical trials
12:00PM - 1:00PM
Matthew Schlumbrecht, MD

Incorporating biomarkers into your clinical trial
12:15PM - 1:00PM
Nina Lukinova, PhD

Saturday, September 20, 2025
Sunday, September 21, 2025
Monday, September 22, 2025
Tuesday, September 23, 2025
Wednesday, September 24, 2025
Thursday, September 25, 2025
Friday, September 26, 2025
Protocol approval from start to finish
10:45AM - 11:30AM
Craig H. Moskowitz, MD

Special session: International clinical trial infrastructure
11:30AM - 12:15PM
Stephane Supiot, MD, PhD
Aisha Mustapha, MBBS

Saturday, September 27, 2025
Sunday, September 28, 2025
Monday, September 29, 2025
Tuesday, September 30, 2025
Wednesday, October 1, 2025
Thursday, October 2, 2025
Friday, October 3, 2025
Patient-reported outcomes in clinical research
10:00AM - 10:45AM
Ruben Mesa, MD

The road to regulatory approval
10:45AM - 11:30AM
Mikkael Sekeres, MD, MS

Saturday, October 4, 2025
Sunday, October 5, 2025
Monday, October 6, 2025
Tuesday, October 7, 2025
Wednesday, October 8, 2025
Thursday, October 9, 2025
Friday, October 10, 2025
Dungeons and Drug Approvals:
10:00AM - 1:00PM
Sarah Chadwell, MS, CGC
Farrah Jackson, MS, CCRP
Leanne Hagen, MS
Carolyn R Raski, MS, CGC

TrialGPT: Matching patients to clinical trials with large language models
10:00AM - 10:45AM
Charalampos S Floudas, MD, DMSc, MS

Digital twins in clinical trials: How they work, and how they don’t
10:45AM - 11:30AM
Alyssa Vanderbeek, MS

Ethics and AI in clinical research
11:30AM - 12:15PM
Louis Voigt, MD

Panel: Benefits and challenges of AI in clinical research
12:15PM - 1:00PM
Louis Voigt, MD

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