About the Event

On March 5, 2024, FDA conducted a public workshop to discuss aspects of complex adaptive, Bayesian, and other novel clinical trial designs.

This meeting was conducted to meet the performance goal of convening a public workshop on complex innovative design (CID) included in the seventh authorization of the Prescription Drug User Fee Act (PDUFA VII).

The purpose of this public workshop was to facilitate discussion on the use of external data sources, Bayesian statistical methods, and simulations in complex innovative trial designs as well as trial implementation.

The meeting consisted of two sessions. The first session focused on case studies illustrating various aspects of complex innovative designs and implementation. The second session consisted of panel discussions motivated by the case studies.

For more information about complex innovative trial design, please visit FDA’s website, Complex Innovative Trial Design Meeting Program.

Meeting Materials

Public Docket

Stakeholders were invited to submit comments through the public docket. The public docket closed on April 5, 2024.

Contact

CID.Meetings@fda.hhs.gov

Content current as of:

09/26/2024

Source

Medically Reviewed By: Felicia Eddings, Pharm.D.

Clinical :: Oncology :: Nuclear :: Geriatric :: Regulatory :: Technology :: Consulting

"My passion is helping businesses, small and large, perform at their best." - Felicia Udoji-Eddings, Pharm.D.

Dr. Felicia Udoji-Eddings is the Founder and CEO of The Health Pals Company, a vertically integrated Healthcare System. As an experienced Clinical Pharmacy Leader, Pharmacy Consultant, Healthcare Executive, and Licensed Pharmacy Practitioner with deep backgrounds in Information Technology (IT), Scientific Research, and Business Management. Dr. Udoji-Eddings has a strong track record of exceptional performance in different business environments. A skilled Business Strategist, Dr. Udoji-Eddings has tackled complex problems and helped several organizations refocus their strategy in tough economic times. As a highly motivated and proactive individual, Felicia enjoys working with teams, in various capacities, to facilitate positive outcomes.

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