Clinical Trials Advisor

Clinical trial stakeholders must look for opportunities to join forces on larger, more meaningful studies to boost trial efficiency, a Duke University researcher tells CTA.

An FDA final rule with stronger restrictions on the work of disqualified trial investigators takes effect May 30 and nearly mirrors an April 2011 proposed version that received little stakeholder feedback.

Clinical sites operating on limited resources may be better off focusing their energy on industry-backed trials, which offer a more sustainable pay structure than cooperative group trials, a new study suggests.

Sponsors can design better studies and avoid accrual pitfalls by engaging with physicians before writing pediatric trial protocols, experts say.

While Congress works to craft legislation encouraging new antibiotics, the Center for Drug Evaluation and Research this year plans to release nine guidances — both new drafts and updates — clarifying the FDA’s views on antibiotic development, a CDER official says.

Three biopharma giants are lending once cast-off drug candidates and corresponding data to government-funded researchers in the hopes outside scientists can develop new uses for the therapies.

The European Medicines Agency (EMA) must increase inspections of foreign trials and work with regulators and ethics bodies in other countries to ensure a robust framework for the oversight and conduct of clinical trials, according to a new agency report.

By a lopsided vote, the FDA’s Circulatory System Devices Panel April 25 recommended approval of the HeartWare Ventricular Assist System (HVAS), in what could be an early sign of more tolerance by advisory committees toward study designs other than traditional double-blind clinical trials.

Some drug-trial sponsors who used the discredited CRO Cetero Research will need to reanalyze or repeat studies, while others will need to conduct an independent third-party data audit, the FDA told drugmakers in late April.

Trial billing is a complicated arena for clinical sites. Yet because it’s an easy area for the government to audit, organizations need to be well informed and prepared.