Clinical Trials Advisor

Drugmakers are urging the FDA to raise drug review issues with sponsors earlier, as one company says its recent complete response letter came after a frustrating lack of communication from the agency.

Draft proposals from Sen. Kay Hagan (D-N.C.) and the Biotechnology Industry Organization (BIO) would allow the FDA to grant marketing authorizations before sponsors meet current clinical trial requirements.

UK Prime Minister David Cameron plans to propose automatically including patient data in clinical research, while allowing patients to opt out if they desire.

Clinical investigators should take heed when discussing a patient’s care with a drug or device sponsor to avoid the appearance of bias.

A new FDA draft guidance offers devicemakers specific goals and methods to ensure that more women are represented in medical device clinical trials.

Trial sites and sponsors shouldn’t fear throwing out paper records, Jules Mitchel, president of eCRO Target Health says.

Drug sponsors should look to their peers as potential partners, not as competitors, if they want to create a more effective and efficient path to cancer drug discovery, CDER Director Janet Woodcock advises.

The federal government should establish a public website to track federally funded research to better ensure human subjects are protected from harm and unethical treatment, the Presidential Commission for the Study of Bioethical Issues says.

Big Pharma saw several pipeline setbacks in December, with AstraZeneca, Sanofi, Novartis and GlaxoSmithKline (GSK) announcing trial failures, a study termination and the end of a drug development program.

The FDA has alerted Onyx Pharmaceuticals to potential review issues for its multiple myeloma drug carfilzomib, including the Oncologic Drugs Advisory Committee’s (ODAC’s) preference for Phase III trials for accelerated approval, Onyx said.

CDER should be allowed to release minutes from its meetings with sponsors during the drug approval process so that a more accurate account of the interactions is made public and the FDA can defend itself against accusations that it shifted its expectations during reviews, an FDA official says.