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

R&D Productivity Still Lags: Study Shows Success Rates May Have Been Overestimated

Executive Summary

Large study tracking drug indications pursued by more than 800 companies over almost a decade finds that only one in 10 wound up getting approved. By therapeutic area, Phase III success rates were lowest in cancer and cardiovascular medicine, and highest in diabetes, infectious and autoimmune disease.

You may also be interested in...



Indication Matters: Study Shows Trial Characteristics Of Approved Drugs Vary Widely Across Diseases

FDA data requirements supporting novel drug approvals vary widely, depending on therapeutic area, with cancer drugs given greatest leniency, suggesting products may need a clinical trial “quality grade,” according to an analysis published in the Journal of the American Medical Association. Another study shows cancer treatments are most likely to get approved on the first try.

Many Drug Approval Delays, Denials Could Be Prevented, FDA Study Shows

Agency reports preventable deficiencies, including failure to select optimal drug doses and suitable study endpoints, account for many drug rejections, approval delays.

Sponsors’ Use Of Adaptive Designs Appears To Be Growing

A Drug Information Association working group survey found 477 studies between Jan. 1, 2008 and Sept. 1, 2011 utilized some type of adaptive design.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS055903

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