Clinical Trials Advisor

Sponsors of new drugs seeking approval with a companion in vitro diagnostic (IVD) need to work with trial sites to ensure they are not prescreening patients by local test methods — a process that can prove fatal for regulatory approval, an expert says.

An independent ethics advisory board could help the FDA assess the risks and benefits of approved drugs and firm up its decisionmaking on required postmarket trials, according to a new report that advocates creating such a group.

Known for its relatively relaxed regulations on companion diagnostics (CDx), the European Medicines Agency (EMA) is not expected to provide guidance on the products until it has more experience in this area, an expert says.

Clinical studies require a tremendous amount of paperwork and data collection — a tall task to keep straight, but a necessary one.

A former Genentech employee is suing the drugmaker, alleging the Roche unit engaged in illegal and unethical conduct during a cancer drug development program, despite being warned to do otherwise.

The FDA has warned a New York-based IRB for failing to have any written procedures describing the ethics committee’s functions and a lack of key documentation, including copies of reviewed research proposals and approved consent forms.

Drugmakers should use an updated instrument for the prospective assessment of suicidal thoughts and behaviors during clinical trials and follow FDA advice on which trials and patients need such assessments, according to a new draft guidance.

Pharma and medical device trade groups are pressuring the Centers for Medicare & Medicaid Services (CMS) to immediately release the nearly year-late Physician Payment Sunshine Act final rule, but they want the agency to hold off on collecting data on drug- and devicemakers’ payments to doctors until 180 days after the rule comes out.

Medical devicemakers should report all adverse events in premarket clinical trials and any device deficiencies that might lead to a serious adverse event (SAE), according to the Global Harmonization Task Force’s (GHTF) final guidance on reportable events.

The FDA has placed a “precautionary” clinical hold on Idenix Pharmaceuticals’ next-generation nucleotide polymerase inhibitor, IDX19368, being developed to treat hepatitis C (HCV) infection.

Eli Lilly’s Alzheimer’s disease candidate solanezumab failed to meet its primary endpoints in a pair of closely watched Phase III trials, but flickers of promise seen in mildly affected Alzheimer’s patients have lifted some analysts’ hopes the drug could still be filed for regulatory approval.