Clinical Trials Advisor

The drug industry needs to get over its risk-averse attitude on much talked about ideas to improve the clinical trials enterprise, and the FDA needs to provide sponsors with enforceable agreements that will give companies the confidence to branch out from the norm, Association of Clinical Research Organization (ACRO) experts say.

Drugmakers would need to submit pediatric study plans to the FDA sooner in the drug development process under a bipartisan Senate bill that would make permanent three programs intended to encourage pediatric trials of medical products.

The FDA’s Reproductive Health Drugs Advisory Committee is recommending approval of Astellas’ overactive bladder (OAB) drug mirabegron, saying unresolved cardiovascular safety concerns are outweighed by the need for new OAB therapies.

Sponsors and CROs will craft trial contracts that are entirely in their favor, but that doesn’t mean sites are tied to this proposal verbatim, a site expert says.

The FDA has halted approval of new trials and enrollment in ongoing studies reviewed by BioMed IRB after two negative assessments of the board’s work.

Trial sponsors should notify the FDA about all adverse events brought to their attention by data monitoring committees (DMC), regardless of whether the safety issue is “serious” or not, according to new guidance.

Sponsors and other clinical trial stakeholders have failed to adapt their business plans to the advancing technological landscape and are missing numerous opportunities to make drug development more affordable, according to a new Institute of Medicine (IOM) report.

BOSTON — Drugmakers need to begin examining new research and development models as financial constraints tighten research budgets, an industry leader says.

To help drugmakers speed new therapies to patients with rare diseases, U.S. and EU regulators should harmonize their philosophies around orphan drug development and generate common guidance on trial requirements, experts say.

Roughly 8 percent of clinical trials inspected by Health Canada between 2004 and 2011 were noncompliant with agency regulations, according to a new report.

Trial billing is an easy area for the government to audit, and noncompliance can result in hefty penalties, Lisa Murtha told listeners at a recent FDAnews webinar on clinical trial billing under Medicare.