How Not to Ruin a Perfectly Good Product With a Flawed Study Design

Held Nov. 14, 2012

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.


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.

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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.

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Participants include everyone who is a key player in designing and managing FDA clinical trials, including:

  • Clinical Research Directors and Study Designers
  • Medical Directors
  • Subject Matter Experts
  • Compliance Officials
  • Regulatory Managers

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Dr. Debbie Wilkerson, Clinical Research Director, Medtronic Spinal.
Dr. Wilkerson oversees clinical development plans, including clinical study designs, for biologics/devices. Her responsibilities include working cross-functionally on clinical trials to ensures on-time implementation and delivery. Dr. Wilkerson’s industry experience has been primarily focused in clinical operations, overlapping with regulatory affairs, drug packaging and labeling, product development, data management and pharmacovigilance. Dr. Wilkerson earned her PhD in biochemistry from the Stanford University School of Medicine.

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