In Vivo is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



This article was originally published in The Gray Sheet

Executive Summary

DEVICE CLINICAL STUDIES SHOULD BE "OVERDESIGNED" to account for the likelihood that some data will be invalidated, Richard Chiacchierini, director of the Division of Biometric Sciences in FDA's Center for Devices and Radiological Health, said, at an FDA/industry teleconference on clinical trials Jan. 27. "Very many medical device manufacturers will design a study on the margin of adequacy," Chiacchierini remarked. "If you have a marginally designed study and something goes wrong, you've probably wasted everything." The teleconference was cosponsored by CDRH and the Food and Drug Law Institute.



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts