Toll Free: +1-888-717-2436


Your Shopping Cart

Contains 0 items
Total: $0.00
View Shopping Cart
Cart Image

customer care
Fax: +1-650-963-2556
Read Frequently Asked Questions

Superiority, Non-inferiority, or Equivalence Trials: How, Why and When

Buy Now Section

This webinar on clinical study design will explore the differences among superiority, Non-inferiority (NI), and equivalence trials, including development of the precise research questions necessary to making a decision about appropriate clinical designs.

Instructor: Rita Hanover
Product ID: 702591
Training Level: Basic

Why Should You Attend:

Randomized Control Trials (RCT) aimed at showing superiority remain the gold standard in clinical trial research, but are not appropriate for trials in which the aim is to show that a new treatment is equivalent or at least non-inferior to the current standard of care. The design of NI and equivalence trials is not as straightforward as that of the RCT superiority trial, and requires precise definitions of the interval of equivalence and/or region of non-inferiority.

This session will explore the differences among superiority, NI, and equivalence trials, including development of precise research questions necessary to make a decision about appropriate clinical designs. The instructor will examine details of representative studies and review relevant FDA guidances.

Areas Covered in the Webinar:

Who Will Benefit:

Professionals who seek to design appropriate clinical investigations for supporting anticipated labeling for a new drug or medical device will find this course valuable. This webinar will also benefit:

Instructor Profile:

Dr. Rita Hanover has worked in clinical research for over 30 years as a principal investigator for studies funded by national agencies such as NIMH, Veteran’s Affairs, and DOD as well as various private pharmaceutical and medical device companies. As a professor, she taught research methods, biostatistics, and evidence-based medicine at the University of Utah School of Medicine, and also served as a consultant to the Utah State Department of Health, and as a director of clinical research for Techniscan Medical Systems. She has concurrently held consulting positions for such companies as Pherin Pharmaceuticals, Utah Cancer Specialists, Montgomery-Watson Environmental Engineering, and Planned Parenthood Federation of America. She earned a Regulatory Affairs Certification (RAC) in 2006 through RAPS, and is also a member of the Society of Clinical Research Associates (SOCRA), and the American Statistical Association (AMSTAT).

Topic Background:

This webinar is directed toward professionals in two broad groups. For those on the side of new drug/device developments that may have safety, ease of administration or advantages over current treatment, this discussion will explain nontraditional clinical trial designs necessary for indication designation and labeling. For those who need to intelligently evaluate clinical study design and outcome for business, regulatory, or evidence-based medical decisions, this is a discussion about how to determine the adequacy and merit of a particular study.

The pharmaceutical and medical device industry increasingly faces the challenge of launching ever more safe and efficient drugs and devices on the market. This often means looking for drugs at least as efficacious, but with some treatment advantage, over those already available, or devices that are less expensive or easier to operate.

Follow us :
Bookmark and Share
Refund Policy
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance.
ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email or call +1-888-717-2436(Toll Free).

COSO Framework for Internal Controls, Risk Assessment and Financial Statement Audit - 80225SEM

This training hasn't been reviewed yet.

Review this training

Training Options Training Duration = 60 Min
$229.00 Access Recorded Version Only
One Person - Unlimited viewing for 6 Months
(For multiple licenses contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
$399.00 Get Training CD Only
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days