FDA News - Clinical Trials
Clinical Trials Advisor is devoted to helping pharmaceutical manufacturers, clinical researchers, IRBs and investigators improve clinical trial operations and GCP compliance. You'll get the latest regulatory and international news, as well as practical advice for maximizing your clinical investments. No other resource provides such valuable reporting and training applicable to every area of clinical trials. From ethics to information technology, training to patient recruitment, accreditation to disclosure — if it impacts clinical trials, CTA covers it.
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.