The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI collaborate to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.

Program Description:

The fundamental principles of statistics, including hypothesis testing, power, multiplicity, mathematical and data adjustments, and statistical confidence will be discussed. These principles applied to study design inform clinical endpoints, sample size, biases, validity, and missing data. At the end of this program the learner will:

• Understand basic statistical principles relate to clinical research and how they affect clinical trial practices and study design
• Differentiate between statistical and clinical significance.
• Evaluate different types of endpoints, e.g., continuous, ordinal, binary, survival, composite, surrogate)
• Identify factors leading to missing data and biases and statistical techniques utilized to manage these factors.

Course Topics:

1. Statistical Inference
2. Hypothesis Testing
3. Statistical Significance and Clinical Significance
4. Power and Sample Size
5. Randomization and Blinding
6. Estimates and Confidence Intervals
7. Multiplicity and Approaches for Multiplicity Adjustments
8. Regulatory Claims
9. Multiple Endpoints vs. Co-Primary Endpoints
10. Different Types of Endpoints
11. Clinical and Surrogate Endpoints
12. Missing Data and Bias

Speaker: Steve Snapinn, PhD, is a managing expert at Advarra. Dr. Snapinn holds a PhD in Biostatistics from the University of North Carolina at Chapel Hill, MS in Bioengineering from Columbia University in the City of New York, and BS in Engineering Science from the University of Virginia. He has over 30 years of experience as a biostatistician in the pharmaceutical industry. Formerly, he was a consultant at Seattle-Quilcene Biostatistics LLC, the Senior Vice President of Biometrics at Alder Biopharmaceuticals Inc., the Vice President of Global Biostatistical Science at Amgen, and the Senior Director of Biostatistics at Merck. He is also the former editor of Statistics in Biopharmaceutical Research and is a fellow of the American Statistical Association. He has shared his expertise about the essential role of statistics in the medical product development process with numerous graduate and doctoral students at USC for 4 years as a guest lecturer. snapinns@gmail.com

Learner Level: Intermediate

Audience:

This symposium is designed for Clinical Research Coordinators, Project Managers, Monitors, Regulatory, Medical and Clinical Affairs Professionals, or junior faculty with three or more years of experience seeking to further develop clinical research skills and principles. Clinical research professionals should have responsibilities that include clinical trial start up planning, mentoring and complex issues involving site management, study management, and sponsor / CRO challenges.

Learner Disclosures:

• Accreditation Status: Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s (ANCC) Commission on Accreditation.
• Financial Relationships: ENPDC has evaluated everyone who has the ability to control content of this activity (planning committee members, subject matter experts, presenters) and found that no relevant financial relationships exist.
• Awarding Contact Hours: To obtain contact hours participants must
• Review the entire activity
• Pass the quiz with 100% of questions answered correctly
• Complete the evaluation at the end
• Certificates will be distributed at the end of the evaluation.
• Enduring Materials Dates:
• Start Date: 09/30/2022
• Expiration Date: 09/29/2025

Need Help with Registration? Please contact us at ene@emory.edu or 404-727-9208.

Program Information: This is the first course in a five (5) course program. To complete the entire program and earn a badge CLICK HERE.