Pink Sheet is part 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

UsernamePublicRestriction
UsernamePublicRestriction

Cardiovascular Outcomes Trials Increasingly Complicated By Missing Data

Executive Summary

As regulators and payers alike look for sponsors to conduct large-scale cardiovascular outcomes trials in a variety of settings, the problem posed by missing data is a slippery slope, as recent FDA advisory committee reviews of Brilinta and Avandia showcase

You may also be interested in...



FDA Panel Looks Beyond Xarelto’s Missing Data Problems To Broader Reforms

Despite the agency’s decision to limit discussion about missing data to the ATLAS pivotal trial of rivaroxaban, Cardio-Renal advisory committee members suggested reforms that sponsors should consider to prevent the kinds of problems seen in ATLAS.

Xarelto Acute Coronary Syndromes Claim Faces Data Quality Hurdle

FDA will ask its cardio-renal advisory committee whether missing data in J&J/Bayer’s ATLAS study affects the interpretability of rivaroxaban’s demonstrated efficacy in acute coronary syndromes. The panel also will be asked whether the agency should pre-specify clinical trial standards for data quality to reduce the problems associated with missing data in CV outcomes studies.

Industry, FDA Face Changes In Handling Of Missing Clinical Trial Data

A new National Academy of Sciences' report on missing clinical trial data is expected to lead to significant changes in how industry sponsors design and conduct studies and statistically account for the effects of drop-outs

Related Content

Topics

UsernamePublicRestriction

Register

OM003387

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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

Cancel