How Not to Ruin a Perfectly Good Product With a Flawed Study Design
Product Details
58% of Phase III trials fail. Why?
Sometimes that’s because the product is ineffective. But more often than not it’s because of poor study design or implementation.
Nearly every day, the newswires burn up with articles about high-profile products that are scrapped by their sponsors.
Or, FDA complete response letters are issued that require sponsors to go back and repeat or revise their clinical trials. Both equate to millions of dollars of time and effort down the drain.
SPECIAL BONUS Receive a comprehensive side-by-side matrix table comparing study design guidelines for drugs, biologics and devices. These guidelines include: ICH E6/E8, FDA CFR 312, FDA CFR 812 and ISO 14155:2011 (Annex A). The matrix table will identify requirements within 89 specific sections of the regulations. |
Receive practical and easy-to-use information that will guarantee further understanding of study design and aid in approvability of an investigational product.
Join Dr. Debbie Wilkerson for a 90-minute audio CD/Transcript session guiding you through examples of recognized study design guidances and best practices from correct and incorrect drug and device case studies. Don’t ruin a perfectly good product with a perfectly flawed study design.
You will learn:
- How to design a valid study that satisfies the FDA and product development endpoints
- Top 5 key issues that need to be addressed when designing a valid study
- Real-world scenarios analyzed as to why some investigational products don’t get approved
- How to tell if there are issues within an already-designed study — the answers will surprise you
This audio CD/Transcript session is intended for both sponsors and sites in the drug and medical device industries.